{"success":true,"data":{"pressRelease":{"id":"178947","rtpr_id":"nGNE1r7XPh-20261025","ticker":"BMY","exchange":"NYSE","all_tickers":["BMY","BNTX","22UAY"],"title":"BioNTech and Bristol Myers Squibb Report Encouraging Global Phase 2 Data for Pumitamig in Advanced NSCLC After Progression on Immunotherapy Plus Chemotherapy","author":"Globe Newswire","published_at":"2026-10-25T07:29:59.860Z","article_body":"* Pumitamig plus docetaxel demonstrated encouraging responses in squamous and\nnon-squamous non-small cell lung cancer across PD-L1 expression levels with a\nconfirmed objective response rate of 36.7% following progression on or after\nimmunotherapy plus chemotherapy\n* An early median progression-free survival of 6.9 months was observed\n* Significant unmet need remains for patients who have progressed on an\nimmunotherapy-containing regimen, with the average progression-free survival\nbelow 4 months for standard of care docetaxel \n* Data represent the third global Phase 2 dataset for pumitamig in lung cancer\nand reinforce its potential to improve outcomes over current standards of\ncare \nMAINZ, Germany, and PRINCETON, USA, October 25, 2026 – BioNTech SE\n(https://www.globenewswire.com/Tracker?data=FFESXgz86UQry27FX4aKXfy5KdqXyrLDir5idZPHgFbGQ74Dadt4gWVgg1SNJFXvYZj1gUEBNxuJ0ebivGfUaoQ6ID1RR0jUd8bpypk-GsgMqVcfVcB8l3ajeEqLdU1rbXg77DeGZ8jEPo-oWn75AW4rtQQaiJ00Li6w2yad3DMvB9KY8e5O4OwnugZ1LYdFfrij1vrAxtlv1kgKPca_ZnWcU16QlVyn8_LEqMOzKqxrHhUR7WYXW506clTzLbZBeVFfDNIo3dpChhJZQSNjTcI3Hj5yB0QmuasaEpuabvOXmANX9sPGiWrgSlb7YTzV6VLqtClZEeG6UmCe_60dT9tnkm1XW678B6fBt2JyjehOBi2s-VivoHZ_xNnI1eIZMTW74juKgfpq8VfbxSMkEvQw6ISQOAKZzw-smZBD_tk=)\n(Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company\n(https://www.globenewswire.com/Tracker?data=zblgaHQ3qRd6nXMy3YgdlHpIjNUZDKHPBB01Kca_3rWrH1E-HczL-o63BiYcE4y3cDT62WhgvL46WZpvTqun6FlJiv0ySvT1Ib0NaGDBGCItRKEq99tGN_NTrt124M-3YzjnhYtB73pHhDdfm8xWDg8zvEAyqfzcSa5sSahb0xVKkRW_zIymHPVJOcm4dSPIzIvDs2mCunoe_7TP1cjOR5bIu_ZXJGmnG0wrP46XxyYrtuIleQNmNa1s542k_TnR5ZqfwWsk1QJ7gqXI0Dd6gnsN5TcCOso2f89_jHpry67bHcINdmtOfCKqCCZhPsE34s7MC0Pc9hsbKva2YQ5CWxxbB5ywHzwASVzcTk4MdkkZl4Ymq3BFfE_GzU9xu-NlZryBu1VfEdW4sGhGbKMo5GnhZg2dQeH5Trq-c-qfNK3gfw6IVuONp0UVwl-HriGQ-fQTRc8NOZz7SBXjsLIenLZ_gWrEjbwcF-uFUHO8NpSsL_y6qfIW2cqunLNj3Ws2M-9DlFnDeG6emad_XwjyqhZovAGiuN3lg6LJykB-HkcxJ0Qhq4XB3Xl_F-gr7V8UBWrMIsWJEMs-3hlDotvf4xYoMBL6O7pahQarX9AkzOg=)\n(NYSE: BMY, “BMS”) today announced first data from the global Phase 2\nROSETTA Lung-107 clinical trial (NCT06841055\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G57SkXzwrQDxd03nF9Bk5uTsQCNISkR05x-BMRKBSrOyHWiquLLes51BXVGq4ZwZEMwizpg8b1LSpO-g1iffqccQHMBLABDy95EmdeDJd3yCN))\nevaluating pumitamig, an investigational PD-L1xVEGF-A bispecific\nimmunomodulator (BNT327/BMS986545), in combination with docetaxel in patients\nwith metastatic non-small cell lung cancer (“NSCLC”) whose disease\nprogressed on or after first-line immunotherapy plus chemotherapy.\n\nThe data showed encouraging antitumor activity, with responses observed in\nboth squamous and non-squamous NSCLC and across PD-L1 expression levels,\ntogether with a manageable safety profile consistent with prior global\ndatasets for pumitamig. The data were presented today in a late-breaking rapid\noral presentation (abstract #LBA76\n(https://www.globenewswire.com/Tracker?data=VRzxRRVxvGMHEfIosjdsFwuzVYbmizsmgfaAoq_zcIqyU35Kv497mMH22UIdVc73Wxnh0emKPXOyyiiVDpNGsahuAHdwlhYb1xZh7QSc4HyDC23DKZ16UH_4X9oPjbPN5xDOdccMh_4_KvEYPtWwrA==))\nat the European Society for Medical Oncology (“ESMO”) Congress 2026 in\nMadrid, Spain.\n\n“Despite meaningful advances in first-line treatment, outcomes remain poor\nfor the many patients with non-small cell lung cancer whose disease progresses\nafter immunotherapy plus chemotherapy, a setting where docetaxel has remained\nthe standard of care for years,”(1) said Byoung Chul Cho, M.D., Ph.D., Trial\nInvestigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei\nUniversity College of Medicine, Seoul, Republic of Korea. “These first data\nfrom ROSETTA Lung-107 show encouraging response rates and progression-free\nsurvival across PD-L1 expression levels and histology, suggesting that\npumitamig may help re-engage antitumor immunity in patients who have\nprogressed on prior immunotherapy plus chemotherapy. These findings support\ncontinued investigation of pumitamig in this population with high unmet\nneed.”\n\nROSETTA Lung-107 is evaluating pumitamig 1400 mg in combination with docetaxel\nevery three weeks. The July 10, 2026, data cut-off included 50 patients with a\nmedian follow-up of 12.2 weeks, and 33 patients remained on treatment. Among\n30 efficacy-evaluable patients, pumitamig plus docetaxel showed a confirmed\nobjective response rate (“cORR”) of 36.7% with a disease control rate\n(“DCR”) of 90.0%. Responses were observed across PD-L1 expression levels\n(cORR: 42.9% TPS ˂ 1%; 33.3% TPS 1–49%; 40.0% TPS ≥ 50%) and histologies\n(cORR: 57.1% squamous; 30.4% non-squamous), with DCRs above 80% in all\nsubgroups. Median time to response was 1.4 months. In the overall treated\npopulation (n=50), median progression-free survival (“PFS”) was 6.9 months\n(95% CI: 4.2 – not reached), with a six-month PFS rate of 63.3%.\nHistorically, standard-of-care docetaxel has delivered a median PFS of\napproximately 3.6 or 3.9 months for non-squamous and squamous metastatic NSCLC\npatients, respectively, following prior immunotherapy plus chemotherapy.(1)\n\n“Our ambition is to improve outcomes for patients across the full spectrum\nof lung cancer, spanning disease subtypes, stages and lines of therapy,”\nsaid Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at\nBioNTech. “These encouraging results for pumitamig plus docetaxel extend the\nclinical evidence to patients whose disease has progressed after immunotherapy\nplus chemotherapy, a setting in which treatment options remain limited.\nTogether with our findings in first-line NSCLC and extensive-stage small cell\nlung cancer, they support our strategy to develop pumitamig across a broad\nrange of lung cancer settings, including those with particularly high unmet\nmedical need.”\n\n“This is the third global Phase 2 dataset to show consistent activity for\npumitamig in lung cancer across PD-L1 expression levels, and it extends our\nevidence into a second-line setting where current options fall short,” said\nCristian Massacesi, Executive Vice President, Chief Medical Officer and Head\nof Development at Bristol Myers Squibb. “Together with BioNTech, we are\nadvancing one of the broadest development programs in the class as we continue\nto build the growing body of clinical evidence for pumitamig across multiple\ntypes and treatment lines of lung cancer, with four ongoing global Phase 3\ntrials, and we look forward to defining the path forward for pumitamig in\nsecond-line NSCLC.”\n\nAcross 50 patients in the safety evaluation, pumitamig plus chemotherapy\nshowed a manageable safety profile, with no new safety signals. Pumitamig\ntreatment-related adverse events (“TRAEs”) of any grade were reported in\n52.0% of patients and grade ≥ 3 TRAEs in 18.0%, leading to treatment\ndiscontinuation in four (8.0%) patients. Immune- related AEs occurred in 11\n(22.0%) patients and grade ≥ 3 immune- related AEs in five (10.0%) patients.\nVEGF-related events were reported in 13 (26.0%) patients; grade 3 events were\nrare (two patients, 4.0%), with no grade 4 or 5 events. Bleeding events\noccurred in eight (16.0%) patients and were limited to grade 1 or 2 severity.\nThere were no pumitamig-related deaths or dose-limiting toxicities\n(“DLTs”).\n\nBioNTech and BMS are advancing a broad development plan for pumitamig in\nmultiple cancer types, including lung cancer across disease stages, subgroups\nand lines of therapy. ROSETTA Lung-107 extends the program into the\nsecond-line NSCLC setting, and these data will inform the further development\nof pumitamig in this underserved patient population.\n\nAbout ROSETTA Lung-107\nThe global, open-label, single-arm Phase 2 ROSETTA Lung-107 trial (NCT06841055\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G5-XkyDnTLPy7RmdS1fqTJpVeC7O7oiruAuLIHIm8fZMGqw3AVL9VHnqSfnwV6bOnxNStiCRaNK7-Jtd8Zf3o0tARon8v4MkeH6QjNB6NfFN0))\nis evaluating pumitamig (BNT327/BMS986545) in combination with docetaxel in\npatients with stage IV squamous or non-squamous NSCLC whose disease progressed\nfollowing first-line immunotherapy plus chemotherapy, with any level of PD-L1\nexpression. Patients with prior exposure to anti-VEGF monoclonal antibodies or\nPD-(L)1xVEGF bispecific antibodies were excluded. In Part 1 (safety run-in),\npatients received pumitamig 1400 mg or 2000 mg plus docetaxel 75 mg/m² every\nthree weeks (Q3W). In Part 2 (dose expansion), patients received pumitamig\n1400 mg plus docetaxel 75 mg/m² Q3W, the dose recommended by the internal\nreview committee based on the totality of evidence from Part 1 and the broader\npumitamig lung cancer program. The primary endpoints are dose-limiting\ntoxicities (Part 1 only), safety, and objective response rate (“ORR”) per\ninvestigator’s assessment (RECIST 1.1). Secondary endpoints include disease\ncontrol rate (“DCR”), duration of response (“DOR”), depth of response,\ntime to response, progression-free survival (“PFS”), overall survival\n(“OS”), pharmacokinetics, and antidrug antibody prevalence. The trial\nenrolled 59 patients at sites in Australia, the Republic of Korea, Spain,\nTürkiye, the United Kingdom, and the United States.\n\nAbout Pumitamig\nPumitamig is an investigational bispecific immunomodulator, jointly developed\nby BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is\naimed at restoring the immune system’s ability to recognize and destroy\ntumor cells while simultaneously cutting off the blood and oxygen supply that\nfeeds tumor cells (anti-angiogenesis effect), preventing them from growing and\nproliferating. By anchoring to PD-L1 receptors on tumor cells, we believe\npumitamig localizes VEGF-A blockade within the tumor microenvironment,\npotentially enhancing antitumor activity while minimizing systemic exposure.\n\nMore than 4,000 patients have been treated with pumitamig in clinical trials\nto date. Seven global Phase 3 trials with registrational potential are\ncurrently ongoing, evaluating pumitamig plus chemotherapy compared to standard\nof care treatments, in first-line small cell lung cancer (ROSETTA Lung-01,\nNCT06712355\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G5xAApvxJRrYgXS4DQGiu1PDF4ioylaqFr2TMj0U55o1U2Hf7o5ERVVFHfYl3vdQTfAFLQsV3cCokQuX3-uFcsz9mvaxEixKBa9bqD2NZT1XL5rhrSqhlhg-gw0zg7zjqMR-SO2D2qa9KF8eCiHcAEnu-RHV7BQKzYuGMc2x9CoEoRAF4_fNk3El1Aa08UTOJ_Sf6OXEHELBHqqB-g9AUKJTfEKoQajYg9HNVZ0bd9wyjHM6HVSWMQHVqVbAI0JD-SG3CEyuIg5ZlmJ4O7O-ti-jFO0v8EH-maLbbx5hq0z5-PIQT67cmY6AgfOdLzC_ajHvZ49PFSv_vb3TUMq3t_DIxc8HQHKZ6St3txnqnylLHtrOKiplt-YI9wDBHa05RkAn1ATZDGT48vMwOJXoKXkA-duccsWJhV1lHuFFlfcE8dSP9wG6UPvDRwC_lSmCTZg==));\nfirst-line non-small cell lung cancer (ROSETTA Lung-02, NCT06712316\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G52J9p6D2n9EIrt5TxB8vuNKdAgtdpupzIhJvurokJAOlqbrBr9ebSCrSdlzA5ocugRPUC-HU2Ieq5vrSjjjSumoGJTVRSMRtxqiIB_mXnrA-CHjuPx01pbgojrXP8fFfMlg6ygKtrh2bYlHZOgNKQxONmcwIe2rHRT7NR0FsANIrZLzGN195Nq9d6snUmNi7VuIyvxnHO9qdVWUo15TS_My4EN4Ulh2_vt2S9OYx6tYMCEeOt53CI-AdgyxBhOOALUHuL-fTO6BDLFksOh5OewMj9h-mph4CQqL8sZGqgUEdZ8LtuOacFc5IVj0TJfD_fXW3CykyyIFxwlVQaB1exzCNlqV6Ft6bqrftrL2xng8LdAABLS4RXf1rqUDBfidbdqMBb33JSuMKERIdH_FlNiaAF9y73e4G_CXrolZQax2W2Cp5kqNtu2MXP34c7u2EPw==));\nunresectable stage III non-small cell lung cancer (ROSETTA Lung-201,\nNCT07361497\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G58f44ypCn7vj5C_cTNXP7mlgT5BAbiqBsbhPijcQc0VL0lc7wBYVN04XAPGBpc4c_Z0QPg8Aasc9vsgliiepWXg-JcioHWTE83WZFb8GyK_QU9IdpFuyMyijKROp6TZiuhah6br6VcxTsEeMK0CNZKG-brL7l5oidXe6DDbx5GgTw8tqfAntXfRdMUKbSEjW-ofwbZ_8A2WDu5vwESDpRBw_NMrmKk4_Cjxy5M7oBhXf6Wwbfpbtwgs1t0iHV4b1u6xQ6CpV3MyVhab_WOxALuQc7OwNv7dTWOrOkox0a90HN7ykNcZzXAIY83TD2RK05yz6OOujJjO_KMPUmpqV7QZwmsm8mGOTSKXQvyuO5VLsJyupCZx2Ki4dgYI3a4hkFgq1TT_TnIZD7W77pgebqvKM3dGM-VicyiDAKbBwSIXPRwgPLV0cwGsyprMmmUZxFg==));\nfirst-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA\nLung-202, NCT07361510\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G5_JrOHSUvqxAiWIUZwio1LIEBpnHW9VLzR4xW1BRmSgUxUvh_wdhxDMzxwU2IeO5n_i6fOWxK1PhKe6S_TXxV8M1IsY1YlXMbJSdhKbvy09zyRCXN_zj1ud-MJKZSdKPUYbaFAnc6_d68AKPL829EHjGkKJNeqXcgUo8ZopMRO_XtHqqhPAmUTfjxh38U2-3OXkylyTPtxCKHekjqIhJiSM9PPYliEgwKvfnT7c3CK4pzH6xgq2nvShYVfq7P6G8GC6f5lwW2C2wLaZ4qrnlU_CH3XeRY9907tGXAA7ooOSr1y9WIKb8W8eVXwSMf_SQdn7ryDA3r5Vi1b4bON-kpmBkSzC_Yx8B6roPh1N6d2juPN_C-ASa9h5pSw6jaerP9JwzIcAr7WT_Q3IBRT_N0OGAH77OxaurAjG4usPhGDwhaLHJX7KBTJlcbkzbqNYJuQ==));\nfirst-line triple-negative breast cancer (ROSETTA Breast-01, NCT07173751\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G59SXIo-nTBvNiwPJxJL8Wj_gh1FLBOQUtLE0GhO8_SJPjZEJXIFLWYllptGmQCEPvu_wM9UJOVNTAUlERPoB7Yr3zPt8QiFpIOKPkaie1ECqaTgkxRsn6iyRLSWt8j648utmtBwMekBAPP3NDrZps1FpvQr2pIlBPqKzWRYYy4z9ZVR3OBiFPX2XUMKP2kMh3dlFLxiSQLl49PRVR9BKCpz0djW8MYTi3Qi3om-MoZnOTiasPgEEdb28InzQKw_hlcGn-yrWPfvh5p8oX-f-CcetwYv25FHdj7dAcm9Y90SE8Wl0qSoIw3BfZfcyw5iVA4_kxcX_AaLqoBYAI8_GNOgQmadm0FJ3l7vjGAHhuPQXeNLb4BLFIVhjQ2rBE7yM-VR5m7DNCPPEIuLlwCH0-Sk1UsQNtp-2ivsbOExqfZs2VDinHksrA6CRMyC98wd_8g==));\nfirst-line microsatellite stable colorectal cancer (ROSETTA CRC-203,\nNCT07221357\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G50PPm2SVDTYnSZUc0kaRUuVrCKeEynDnYZ9l24pMHu9zk_5LfFJGdcmzxsUF1b3t9-4xxhoEeZGld5celaQ1cY9D3n4LR_tTXH52mXVnKUCWcYVot3nVDUzePNJ44a4BTPk2f25SIHxWBJWy_yAQ_y824VtO66u8fGoawh6jZGkwZ5auUo0FcNY0vzFZ3JWNQ5UgULtIotkmJq2OzEwpoi7oOrSVXSSSzEpAzoh7Of7uQbUZeB8iVjkdkb6pq1Bl1iDGiqJxPIp9HkWGC4nIjpXfbKmL-yiW00zoPR0OV21Eo04Naj4KaYI6-SFPaqTp2fbtXHvCYL3xQwAvg2OIQpYwUrppaqroH5EXtnOw7CIiybPvB7BkgtZc95e71M0yPSyzKzT7bgILyDd1qRUvHiRPE-NCBDCaX-pbzrPscPOC_-1CUJyuYvGyX2Q05K_ROg==));\nand first-line gastric cancer (ROSETTA Gastric-204, NCT07221149\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G5-KDfyJdMec5T4bXeWphJ15p3saI9zHNmpmHJ9ZijsTsJGoEpcP1NohZ3DmyTCq0vdpFqGaKjtLicLW3JFd0upqtpGgExL1o6iohzc3OREucRTmeu3Fmly2rDVyPXqLiC30DySRqI2s-Uvf5t058FRB33gFD4v0S-g_njMQdBXhh8rhF2EmK5mB_srqSoKRF4CZRKBhDANHNlGM-MR6KyotSNkWJpdLnB73qvI7PQEFZmD_qjQaHRKeUTOy5E8ZRLgzGM-N9JPUEp_kNVrEz3MUa4PEW9SLC9HD2-iolxBjgrcFYjJXnO-J0hNjFU-hcNBeaEDr0XSRTB24imJlDT5KOxDZKsd6S4FsfSbjGnh0luFEmvuL3W5SNWiQ0fDPsB1qfHBxLA8qIdoQKnmGvD3LTeTwNMFo9TBxEqxa4oc6LFFbllGvzUOhSFvIWAU4gEw==)).\nPumitamig is also being explored in 10+ novel-novel combination trials with\nADCs and other novel modalities, with the aim of expanding its role across\ntumor types and identifying additional pivotal opportunities.\n\nAbout NSCLC\nNon-small cell lung cancer (NSCLC) covers all epithelial lung cancers other\nthan small cell lung cancer and includes squamous cell carcinoma, large cell\ncarcinoma, and adenocarcinoma of the lung. It is the most common type of lung\ncancer, accounting for approximately 85% of cases, and is the leading cause of\ncancer-related deaths worldwide.(2) Scientific advances have transformed the\ntreatment of NSCLC, improving outcomes for many patients. However, NSCLC\nremains an aggressive disease with a poor prognosis and a 5-year survival rate\nof 18 to 22% in advanced stages.(3) Patients with low levels of PD-L1\nexpression typically do not respond well to checkpoint inhibitor-based\nregimens creating a significant unmet need for new treatment options that\nprovide durable responses to a broad range of patients.\n\nAbout BioNTech\nBioNTech is a global next generation biopharmaceutical company pioneering\nnovel investigative therapies for cancer and other serious diseases. In\noncology, BioNTech is committed to transforming how cancer is treated. Its\nambition is to develop innovative medicines with pan-tumor or synergistic\npotential to address cancer from multiple angles and across the full continuum\nof the disease from early- to late-stage. Its growing late-stage oncology\npipeline comprises complementary treatment approaches spanning\nimmunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies.\nBioNTech has partnered with multiple global and specialized pharmaceutical\ncollaborators leveraging complementary expertise and resources to accelerate\ninnovation and drive progress, including Bristol Myers Squibb, Duality\nBiologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4,\nand Pfizer.\n\nFor more information, please visit www.BioNTech.com.\n\nBioNTech Forward-Looking Statements\nThis press release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995, as amended, including,\nbut not limited to, statements concerning: BioNTech’s collaboration with\nBristol Myers Squibb (BMS); BioNTech and BMS’s ability to successfully\nco-develop and co-commercialize pumitamig (also known as BNT327 or BMS986545),\nif approved; the rate and degree of market acceptance of pumitamig, if\napproved; the initiation, timing, progress, and results of BioNTech’s\nresearch and development programs, including BioNTech’s current and future\nclinical trials, including statements regarding the expected timing of\ninitiation, enrollment, and completion of trials and related preparatory work\nand the availability of results, and the timing and outcome of applications\nfor regulatory approvals and marketing authorizations, including expectations\nregarding the potential indications in which pumitamig may be approved, if at\nall; the targeted timing and number of additional potentially registrational\ntrials, and the registrational potential of any trial BioNTech may initiate;\nand discussions with regulatory agencies. In some cases, forward-looking\nstatements can be identified by terminology such as “will,” “may,”\n“should,” “expects,” “intends,” “plans,” “aims,”\n“anticipates,” “believes,” “estimates,” “predicts,”\n“potential,” “continue,” or the negative of these terms or other\ncomparable terminology, although not all forward-looking statements contain\nthese words.\n\nThe forward-looking statements in this press release are based on BioNTech’s\ncurrent expectations and beliefs of future events and are neither promises nor\nguarantees. You should not place undue reliance on these forward-looking\nstatements because they involve known and unknown risks, uncertainties, and\nother factors, many of which are beyond BioNTech’s control and which could\ncause actual results to differ materially and adversely from those expressed\nor implied by these forward-looking statements. These risks and uncertainties\ninclude, but are not limited to: the uncertainties inherent in research and\ndevelopment, including the ability to meet anticipated clinical endpoints,\ncommencement and/or completion dates for clinical trials, regulatory\nsubmission dates, regulatory approval dates and/or launch dates, as well as\nrisks associated with clinical data, and including the possibility of\nunfavorable new preclinical, clinical or safety data and further analyses of\nexisting preclinical, clinical or safety data; the nature of clinical data,\nwhich is subject to ongoing peer review, regulatory review and market\ninterpretation; the impact of tariffs and escalations in trade policy;\ncompetition related to BioNTech’s product candidates; the timing of and\nBioNTech’s ability to obtain and maintain regulatory approval for its\nproduct candidates; BioNTech’s ability to identify research opportunities\nand discover and develop investigational medicines; the ability and\nwillingness of BioNTech’s third-party collaborators to continue research and\ndevelopment activities relating to BioNTech’s product candidates and\ninvestigational medicines; unforeseen safety issues and potential claims that\nare alleged to arise from the use of products and product candidates developed\nor manufactured by BioNTech; BioNTech’s and its collaborators’ ability to\ncommercialize and market its product candidates, if approved; BioNTech’s\nability to manage its development and related expenses; regulatory and\npolitical developments in the United States and other countries; BioNTech’s\nability to effectively scale its production capabilities and manufacture its\nproducts and product candidates; and other factors not known to BioNTech at\nthis time.\n\nYou should review the risks and uncertainties described under the heading\n“Risk Factors” in BioNTech’s Report on Form 6-K for the period ended\nJune 30, 2026 and in subsequent filings made by BioNTech with the SEC, which\nare available on the SEC’s website at www.sec.gov. These forward-looking\nstatements speak only as of the date hereof. Except as required by law,\nBioNTech disclaims any intention or responsibility for updating or revising\nany forward-looking statements contained in this press release in the event of\nnew information, future developments or otherwise.\n\nAbout Bristol Myers Squibb\nAt Bristol Myers Squibb, our mission is to discover, develop and deliver\ninnovative medicines that help patients prevail over serious diseases. We are\npursuing bold science to define what’s possible for the future of medicine\nand the patients we serve. For more information, visit us at BMS.com\n(https://www.globenewswire.com/Tracker?data=pD5llnupv3KxpW8LYEJsY7Ivd-wVKsNYX74qryuATuXVzzExu2ItfSjqL6fUzG9VoTlzxNGMaEZlAucEEBvvx6I_fsRdkS-K4UOLR7ScwsmqatK4zZ621oPvup7BKqO4rEvAXMcpN165aIPqS8eLg_2RKCUdLcBirbxHhkuUG0CMJeqpdwv_Ub_iyIMuoNPXVlVvNy-jCRhaDYozDK2RN0VN63n4odKC5_waH5XFaNpMKAcvMuKYJAcb-AiKkRcbm7s7m4pL7stUWbnizvJbUh7aITApc2_xqAUSs-SWwLg6A-BRRHdzYBr1Go54VjorcyU6CMi13JxvzKaraV-KbHT0rIuzwrRmiSZDX3eD21z1NPfuoJbfhePnuXUPkjurv43jWTEcSERFJkZmfaNBYg3EnHXh5RwssACemuYDIg9LjcRULiLwtoKD3VB109-Qp7oag84nOZ94plBpgIZpD157ouutEgA0JvekyWOUxarKKzhbpqZfFFZs3Yv4uvrAnNxyY9zEyC5w4YIsAkR1R-mansK6bzRGoudc35ppNYI75ZIsatVuFeFkZM0-d-EHMhuYglKDUbubw30kSd785J8h6wwZk7osq0M1XpATBRz7zNXf844lYcOAHFL0WhyJyOuOHh5WT-nemGbdsDaXdw==)\nand follow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=_mPPvG3IGmljxKf5WajbrxKO8tWYg9PaWjOCXRoyjceWUKepxpA4O__Zl6ukUkUv6tdAFC3u8htCtXyBUENSyWDyAdc1So4sNjuxRmEsKHgFpAU_VxSgHDsJEZcqWQFAbzP1Eir2qlV7-jw4jqiGitFPI0Rv1SHtnRyKSBq3R2To3DjCsXZ7jKteO9fMUpe106lhtX21p9mPkHyT3_qAYTubsNuszSyYTDKbqI-ZxlFE4rBLpDvqcen9JmW0vAwcxM9dqW9_Ca3Zcc1r89pL_ym_hYA0SeoMNoLTK3MwGzreFW87C-OQ4mNMwWPfthXdnSLWvwEcN2Zorq_i0ai1dEXsgInugGVIVvJjr6CcTzSoJAD2_COa6NJFMY7ACsnQUbhEeH7x6zWhq3n_W1IpV3D7ygu9CkmLtNT0YB0149L25WHnp4NrYC9_GAtZ4AcVz_RLotjtx8iTMfkwbJhuDQPo4_KvAx5m0bQ-LrNpm979F5FyQtD3hczpeLQfAZBdMLvufkYSmGkxynJOrsSrlQncgl_SxFcm1wZHByXtS8AfnBoj94mPjJ3WlG7O9r5BGn9icFrw0ZnT5ROdWyje0hopes_odtMR4Nm9Eujf3sXzxYlJ_pawn-i_M4XAnBQYKKjtLsVG7YP4wCSrYyqyZkeASaFDven-5voY_SUN8KkFBPDCPrMU4n_Vkd96thXF),\nX\n(https://www.globenewswire.com/Tracker?data=tHdLFK7BHZZjQj0mWOVgmcZrjHcoiwmpJ4ye3zSsnra7tMo41fJwVGbV31b-ljGoLKr7Ogv_sa34YyPn8C1vNm0evhjj3xArnUDW1aFHiJVCovKK90XyasANVB5lIeFyhzz_CLzpPHKvNPS57DfadMGR5wDwNerwlIGpdMgEbBHd6MzP75R9WmUaLN5vXh5gXBjTE3CiHHqlY277INZf-OOHOnI5ii_7HHLZCpLNqR4QAoBXDv559tLz_UViZn4IbKnNYRrClpytA4RR9wD9Ry-DiEfCPV2S8hJY-QuM56oIOrzptvLi47BaSzJD2kYtx9XNVJ62vVnJfECYGJ53bq14dcUSWlgk5KjXtgwEWdZe9sMnqSzPKB3k7hej2SqAR_E0A2h_eQ9XwOEDqMdBSFjJktgnkBf9u_umDwZ40vdhcqX928BAgG_VND4WKElxlYduYDQ_5W37561RSpTC2E1IGsjf6Jy_iawPpcpBRMks6LRV1OaYrqM-CSpie4nZ8BCxqXp5Bc_YfWoe0g2EnDN6v10AdWPkTjT9N2QGL4Z4Mrqyd_yBv9VtzHh8aHhiLsZPNtYiAd5SbRQ000MbCuVelZOoUCuWfUSJnPx0y4Yq_PaDQjgT5QUeyRX8IyIl),\nYouTube\n(https://www.globenewswire.com/Tracker?data=-sx42NDPOOFV-w11MAb6ubYhwOkqv94bRtce6hq7iLXdzLpAgEb4d6RlaKQvIdCHtcUI3ea1yOAtRtJZnf1E4OjmMra1cX6TeOp55bMuTR53YIx_uyL7NrxHu7YpTGAr772hzhRQa1xt3GjlcTiC3bFcJXf9nup2m4G8ghwXe_3H9bSA-fpEyuQ6yYPrqTrHFM40LweJwgg7DSDh7s3XpqrzcXc7dgd86G5eAQ-qH6GwtwzrAzcRiCXgkAk7zYsT3yfTOx9D0UphXwZLnToBoOrTngzehjLs0BuwHUn5wR0pPJSMqQ1fF5AqqEs1qyPHYUaJmyD9cymu7xyYM99_U5isSni4vPYXa8MRUftnj0oPB0fici100oARbQucG0vB4fb2Ob-8bbMZjCsCx3bmSbfVRv_O51VFbxGK6o_kR7y96zQsXJTUceXJ5MprVNQvi8lxU-WUK16sSu1WQquaRfd97wvaISp5S629t5gAYcNJRC-xINDVJLBIBSespqTD7F0BiloGedf-yn2_kGXD19Pz8LW-DqnX-PBeWFN46PGimH2HK2oRotFYZYi6Nt_wdX9cZ1n3CS3PCzZlS6qOOPdLyHqGuntj1kz1LJCQl8M9qGO6BZ1nmyrW_RI4oCGNr1_B0v0EhozkP3-c-auOK2zfOII1ztZEt5xTmpEbIFsPE7S5UIgefAI2UcXmFW5M),\nFacebook\n(https://www.globenewswire.com/Tracker?data=H6rMO12VUECSjVU7gTaXoondcpI5zgh0QvS2Pe8B582djTuhXY3OTYKjpLl1ARgZ47xQNM1JDuaEaWyHqyQnVgkpREE8Ke33DBJLdRX-HV_sRJ-C4rHcO7BZS7NQYuFClb6obEGyIpEsQsbYQrUlmMY3azfDZPuTfmiqm0r2PStPLDHQ5OzxKQdfVLE1ahXB3_-9dSqnEfypWGfplWb__KxUIXV7eUqZR3d79WmYVhXYLmKnkgjVsk5CvQlMyURT2yUzUPLRN9Y4MrM47lr-LWjn_M155fWAYb8DHY3vOzvFNkxUzhcjMVmRO54-XyF-an_w2ZjlTI8xoq2YqI3Cvg6QdrHOGVvOKDQrlz1sMjN4iy3-_3h737eKeC77MET6on7Os9mlFZnqCIaR14TgvoidK1dVOpnn2idojKYkeh6ZKDADm5H75aM7XD08x3TuGhSv9YDzYKuoeMM3_aExKccMl4e_FroXB1ySrOZ6rzQH2GU3nDv5nKYisAf_EZRjLTPtbVd9u4pWi7awG5KwSSm5kg3XL27R-zT-33gUTmGplnujU-1X7zLwWhSBDbOFfiS4SLVScW3FT_6IExUdSxgW9bdf2VdJJmJyfN5kJQ7NaCY99oE0m7_K8OAAB6wbhVH_XUaxuRZ1ItShFvHycm--9I8CM62C6U_4pxzZ82o=)\nand Instagram\n(https://www.globenewswire.com/Tracker?data=2CQpGHKHTPqqjxetbLH0g7KpRwVRg6JPeqnU4sHqiJYiaqyDMB1C7HIjPbvh3gTxh0wHVwGR1P_yhVCRCWPP5tWYG0v_0WwyZb0DwFfbUkNHmTcCTrC7KiuH0vE-yfUHVhfbtVljK0LgwWL6ZshL_WvxTIJg108ilHO8uq2qMaM6KE8QyiCNDT3LVyOxW0BAuwT13notc74en12vDmLlL_UUU3is1J8s2kDXXHVEP2QzcN30yeNISiqIg1OgRIzDX3kITckgdFWcPU2RxxV8y1Ornu8wRMR7MQNtJNt1GJ3bvZuYq_LciSGPRC81bwbgPTgPHTwtOs5Cgi1a-K8B6YBJp3RYJ7DiJ2X3YbWGA3QdXE3yV0N7Z64rnsMpU08uPozXOOnJb1fQvMnkakbiQzbMq4cKFzL9gMV0P3oSaVYPCBO4hT-5sopKXM-z3oIsVB4DMlHSuHzuSHgCtvFbRSSD2Er6k6wCjnZAwLYzwWWDL54Oq6bI00rN8Ds6KmqAHIXVet-_0k8p3e02FO659FWNuTsi2QHpOpP-XbnX5_11_mmKkzRTzo-bb4o0XzkUqZhdjZzpFfI_f4H-7jRPITSlWZz7XOKEuCkRwVBbxNdZsp2mYcqRz8FE6ApzbUEPCihutRJ_eVZAzyjqdQpthEAVAND3miqik_UYfGn8-AhjkX00FoYxg2QpH5gZgCdA).\n\nBristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements\nThis press release contains “forward-looking statements” within the\nmeaning of the Private Securities Litigation Reform Act of 1995 regarding,\namong other things, the research, development and commercialization of\npharmaceutical products. All statements that are not statements of historical\nfacts are, or may be deemed to be, forward-looking statements. Such\nforward-looking statements are based on current expectations and projections\nabout Bristol Myers Squibb’s future financial results, goals, plans and\nobjectives and involve inherent risks, assumptions and uncertainties,\nincluding internal or external factors that could delay, divert or change any\nof them in the next several years, that are difficult to predict, may be\nbeyond our control and could cause future financial results, goals, plans and\nobjectives to differ materially from those expressed in, or implied by, the\nstatements. These risks, assumptions, uncertainties and other factors include,\namong others, that the expected benefits of, and opportunities related to the\ncollaboration with BioNTech may not be realized by Bristol Myers Squibb or may\ntake longer to realize than anticipated, that future study results may not be\nconsistent with the results to date, that pumitamig (also known as BNT327 or\nBMS986545) alone or in combination with chemotherapy (such as docetaxel) may\nnot achieve its primary study endpoint or receive regulatory approval for the\nindications described in this release in the currently anticipated timeline or\nat all, any marketing approvals, if granted, may have significant limitations\non their use, and, if approved, whether pumitamig alone or in combination with\nchemotherapy will be commercially successful. No forward-looking statement can\nbe guaranteed. Forward-looking statements in this press release should be\nevaluated together with the many risks and uncertainties that affect Bristol\nMyers Squibb’s business and market, particularly those identified in the\ncautionary statement and risk factors discussion in Bristol Myers Squibb’s\nAnnual Report on Form 10-K for the year ended December 31, 2025, as updated by\nBristol Myers Squibb’s subsequent Quarterly Reports on Form 10-Q, Current\nReports on Form 8-K and other filings with the Securities and Exchange\nCommission. The forward-looking statements included in this document are made\nonly as of the date of this document and except as otherwise required by\napplicable law, Bristol Myers Squibb undertakes no obligation to publicly\nupdate or revise any forward-looking statement, whether as a result of new\ninformation, future events, changed circumstances or otherwise.\n\nCONTACTS\n\nBioNTech\nMedia Relations\nJasmina Alatovic\nMedia@biontech.de\n\nInvestor Relations\nDouglas Maffei, PhD\nInvestors@biontech.de\n\nBristol Myers Squibb\nMedia Relations\nmedia@bms.com  \n\nInvestor Relations\nInvestor.relations@bms.com\n\n1. Ahn MJ et al. J Clin Oncol. 2025;43(3):260–272.\n2. Lin Z et al. Medicine (Baltimore). 2025 Jul 25;104(30):e43300.\n3. Liu SV et al. Immunotherapy. 2025 Oct;17(14):1005-1013.","article_body_html":"","raw_payload":{"data":{"id":"nGNE1r7XPh-20261025","title":"BioNTech and Bristol Myers Squibb Report Encouraging Global Phase 2 Data for Pumitamig in Advanced NSCLC After Progression on Immunotherapy Plus Chemotherapy","author":"Globe Newswire","ticker":"BMY","created":"2026-10-25T07:29:59.860Z","tickers":["BMY","BNTX","22UAY"],"exchange":"NYSE","article_body":"* Pumitamig plus docetaxel demonstrated encouraging responses in squamous and\nnon-squamous non-small cell lung cancer across PD-L1 expression levels with a\nconfirmed objective response rate of 36.7% following progression on or after\nimmunotherapy plus chemotherapy\n* An early median progression-free survival of 6.9 months was observed\n* Significant unmet need remains for patients who have progressed on an\nimmunotherapy-containing regimen, with the average progression-free survival\nbelow 4 months for standard of care docetaxel \n* Data represent the third global Phase 2 dataset for pumitamig in lung cancer\nand reinforce its potential to improve outcomes over current standards of\ncare \nMAINZ, Germany, and PRINCETON, USA, October 25, 2026 – BioNTech SE\n(https://www.globenewswire.com/Tracker?data=FFESXgz86UQry27FX4aKXfy5KdqXyrLDir5idZPHgFbGQ74Dadt4gWVgg1SNJFXvYZj1gUEBNxuJ0ebivGfUaoQ6ID1RR0jUd8bpypk-GsgMqVcfVcB8l3ajeEqLdU1rbXg77DeGZ8jEPo-oWn75AW4rtQQaiJ00Li6w2yad3DMvB9KY8e5O4OwnugZ1LYdFfrij1vrAxtlv1kgKPca_ZnWcU16QlVyn8_LEqMOzKqxrHhUR7WYXW506clTzLbZBeVFfDNIo3dpChhJZQSNjTcI3Hj5yB0QmuasaEpuabvOXmANX9sPGiWrgSlb7YTzV6VLqtClZEeG6UmCe_60dT9tnkm1XW678B6fBt2JyjehOBi2s-VivoHZ_xNnI1eIZMTW74juKgfpq8VfbxSMkEvQw6ISQOAKZzw-smZBD_tk=)\n(Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company\n(https://www.globenewswire.com/Tracker?data=zblgaHQ3qRd6nXMy3YgdlHpIjNUZDKHPBB01Kca_3rWrH1E-HczL-o63BiYcE4y3cDT62WhgvL46WZpvTqun6FlJiv0ySvT1Ib0NaGDBGCItRKEq99tGN_NTrt124M-3YzjnhYtB73pHhDdfm8xWDg8zvEAyqfzcSa5sSahb0xVKkRW_zIymHPVJOcm4dSPIzIvDs2mCunoe_7TP1cjOR5bIu_ZXJGmnG0wrP46XxyYrtuIleQNmNa1s542k_TnR5ZqfwWsk1QJ7gqXI0Dd6gnsN5TcCOso2f89_jHpry67bHcINdmtOfCKqCCZhPsE34s7MC0Pc9hsbKva2YQ5CWxxbB5ywHzwASVzcTk4MdkkZl4Ymq3BFfE_GzU9xu-NlZryBu1VfEdW4sGhGbKMo5GnhZg2dQeH5Trq-c-qfNK3gfw6IVuONp0UVwl-HriGQ-fQTRc8NOZz7SBXjsLIenLZ_gWrEjbwcF-uFUHO8NpSsL_y6qfIW2cqunLNj3Ws2M-9DlFnDeG6emad_XwjyqhZovAGiuN3lg6LJykB-HkcxJ0Qhq4XB3Xl_F-gr7V8UBWrMIsWJEMs-3hlDotvf4xYoMBL6O7pahQarX9AkzOg=)\n(NYSE: BMY, “BMS”) today announced first data from the global Phase 2\nROSETTA Lung-107 clinical trial (NCT06841055\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G57SkXzwrQDxd03nF9Bk5uTsQCNISkR05x-BMRKBSrOyHWiquLLes51BXVGq4ZwZEMwizpg8b1LSpO-g1iffqccQHMBLABDy95EmdeDJd3yCN))\nevaluating pumitamig, an investigational PD-L1xVEGF-A bispecific\nimmunomodulator (BNT327/BMS986545), in combination with docetaxel in patients\nwith metastatic non-small cell lung cancer (“NSCLC”) whose disease\nprogressed on or after first-line immunotherapy plus chemotherapy.\n\nThe data showed encouraging antitumor activity, with responses observed in\nboth squamous and non-squamous NSCLC and across PD-L1 expression levels,\ntogether with a manageable safety profile consistent with prior global\ndatasets for pumitamig. The data were presented today in a late-breaking rapid\noral presentation (abstract #LBA76\n(https://www.globenewswire.com/Tracker?data=VRzxRRVxvGMHEfIosjdsFwuzVYbmizsmgfaAoq_zcIqyU35Kv497mMH22UIdVc73Wxnh0emKPXOyyiiVDpNGsahuAHdwlhYb1xZh7QSc4HyDC23DKZ16UH_4X9oPjbPN5xDOdccMh_4_KvEYPtWwrA==))\nat the European Society for Medical Oncology (“ESMO”) Congress 2026 in\nMadrid, Spain.\n\n“Despite meaningful advances in first-line treatment, outcomes remain poor\nfor the many patients with non-small cell lung cancer whose disease progresses\nafter immunotherapy plus chemotherapy, a setting where docetaxel has remained\nthe standard of care for years,”(1) said Byoung Chul Cho, M.D., Ph.D., Trial\nInvestigator and Professor of Medical Oncology at Yonsei Cancer Center, Yonsei\nUniversity College of Medicine, Seoul, Republic of Korea. “These first data\nfrom ROSETTA Lung-107 show encouraging response rates and progression-free\nsurvival across PD-L1 expression levels and histology, suggesting that\npumitamig may help re-engage antitumor immunity in patients who have\nprogressed on prior immunotherapy plus chemotherapy. These findings support\ncontinued investigation of pumitamig in this population with high unmet\nneed.”\n\nROSETTA Lung-107 is evaluating pumitamig 1400 mg in combination with docetaxel\nevery three weeks. The July 10, 2026, data cut-off included 50 patients with a\nmedian follow-up of 12.2 weeks, and 33 patients remained on treatment. Among\n30 efficacy-evaluable patients, pumitamig plus docetaxel showed a confirmed\nobjective response rate (“cORR”) of 36.7% with a disease control rate\n(“DCR”) of 90.0%. Responses were observed across PD-L1 expression levels\n(cORR: 42.9% TPS ˂ 1%; 33.3% TPS 1–49%; 40.0% TPS ≥ 50%) and histologies\n(cORR: 57.1% squamous; 30.4% non-squamous), with DCRs above 80% in all\nsubgroups. Median time to response was 1.4 months. In the overall treated\npopulation (n=50), median progression-free survival (“PFS”) was 6.9 months\n(95% CI: 4.2 – not reached), with a six-month PFS rate of 63.3%.\nHistorically, standard-of-care docetaxel has delivered a median PFS of\napproximately 3.6 or 3.9 months for non-squamous and squamous metastatic NSCLC\npatients, respectively, following prior immunotherapy plus chemotherapy.(1)\n\n“Our ambition is to improve outcomes for patients across the full spectrum\nof lung cancer, spanning disease subtypes, stages and lines of therapy,”\nsaid Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at\nBioNTech. “These encouraging results for pumitamig plus docetaxel extend the\nclinical evidence to patients whose disease has progressed after immunotherapy\nplus chemotherapy, a setting in which treatment options remain limited.\nTogether with our findings in first-line NSCLC and extensive-stage small cell\nlung cancer, they support our strategy to develop pumitamig across a broad\nrange of lung cancer settings, including those with particularly high unmet\nmedical need.”\n\n“This is the third global Phase 2 dataset to show consistent activity for\npumitamig in lung cancer across PD-L1 expression levels, and it extends our\nevidence into a second-line setting where current options fall short,” said\nCristian Massacesi, Executive Vice President, Chief Medical Officer and Head\nof Development at Bristol Myers Squibb. “Together with BioNTech, we are\nadvancing one of the broadest development programs in the class as we continue\nto build the growing body of clinical evidence for pumitamig across multiple\ntypes and treatment lines of lung cancer, with four ongoing global Phase 3\ntrials, and we look forward to defining the path forward for pumitamig in\nsecond-line NSCLC.”\n\nAcross 50 patients in the safety evaluation, pumitamig plus chemotherapy\nshowed a manageable safety profile, with no new safety signals. Pumitamig\ntreatment-related adverse events (“TRAEs”) of any grade were reported in\n52.0% of patients and grade ≥ 3 TRAEs in 18.0%, leading to treatment\ndiscontinuation in four (8.0%) patients. Immune- related AEs occurred in 11\n(22.0%) patients and grade ≥ 3 immune- related AEs in five (10.0%) patients.\nVEGF-related events were reported in 13 (26.0%) patients; grade 3 events were\nrare (two patients, 4.0%), with no grade 4 or 5 events. Bleeding events\noccurred in eight (16.0%) patients and were limited to grade 1 or 2 severity.\nThere were no pumitamig-related deaths or dose-limiting toxicities\n(“DLTs”).\n\nBioNTech and BMS are advancing a broad development plan for pumitamig in\nmultiple cancer types, including lung cancer across disease stages, subgroups\nand lines of therapy. ROSETTA Lung-107 extends the program into the\nsecond-line NSCLC setting, and these data will inform the further development\nof pumitamig in this underserved patient population.\n\nAbout ROSETTA Lung-107\nThe global, open-label, single-arm Phase 2 ROSETTA Lung-107 trial (NCT06841055\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G5-XkyDnTLPy7RmdS1fqTJpVeC7O7oiruAuLIHIm8fZMGqw3AVL9VHnqSfnwV6bOnxNStiCRaNK7-Jtd8Zf3o0tARon8v4MkeH6QjNB6NfFN0))\nis evaluating pumitamig (BNT327/BMS986545) in combination with docetaxel in\npatients with stage IV squamous or non-squamous NSCLC whose disease progressed\nfollowing first-line immunotherapy plus chemotherapy, with any level of PD-L1\nexpression. Patients with prior exposure to anti-VEGF monoclonal antibodies or\nPD-(L)1xVEGF bispecific antibodies were excluded. In Part 1 (safety run-in),\npatients received pumitamig 1400 mg or 2000 mg plus docetaxel 75 mg/m² every\nthree weeks (Q3W). In Part 2 (dose expansion), patients received pumitamig\n1400 mg plus docetaxel 75 mg/m² Q3W, the dose recommended by the internal\nreview committee based on the totality of evidence from Part 1 and the broader\npumitamig lung cancer program. The primary endpoints are dose-limiting\ntoxicities (Part 1 only), safety, and objective response rate (“ORR”) per\ninvestigator’s assessment (RECIST 1.1). Secondary endpoints include disease\ncontrol rate (“DCR”), duration of response (“DOR”), depth of response,\ntime to response, progression-free survival (“PFS”), overall survival\n(“OS”), pharmacokinetics, and antidrug antibody prevalence. The trial\nenrolled 59 patients at sites in Australia, the Republic of Korea, Spain,\nTürkiye, the United Kingdom, and the United States.\n\nAbout Pumitamig\nPumitamig is an investigational bispecific immunomodulator, jointly developed\nby BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is\naimed at restoring the immune system’s ability to recognize and destroy\ntumor cells while simultaneously cutting off the blood and oxygen supply that\nfeeds tumor cells (anti-angiogenesis effect), preventing them from growing and\nproliferating. By anchoring to PD-L1 receptors on tumor cells, we believe\npumitamig localizes VEGF-A blockade within the tumor microenvironment,\npotentially enhancing antitumor activity while minimizing systemic exposure.\n\nMore than 4,000 patients have been treated with pumitamig in clinical trials\nto date. Seven global Phase 3 trials with registrational potential are\ncurrently ongoing, evaluating pumitamig plus chemotherapy compared to standard\nof care treatments, in first-line small cell lung cancer (ROSETTA Lung-01,\nNCT06712355\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G5xAApvxJRrYgXS4DQGiu1PDF4ioylaqFr2TMj0U55o1U2Hf7o5ERVVFHfYl3vdQTfAFLQsV3cCokQuX3-uFcsz9mvaxEixKBa9bqD2NZT1XL5rhrSqhlhg-gw0zg7zjqMR-SO2D2qa9KF8eCiHcAEnu-RHV7BQKzYuGMc2x9CoEoRAF4_fNk3El1Aa08UTOJ_Sf6OXEHELBHqqB-g9AUKJTfEKoQajYg9HNVZ0bd9wyjHM6HVSWMQHVqVbAI0JD-SG3CEyuIg5ZlmJ4O7O-ti-jFO0v8EH-maLbbx5hq0z5-PIQT67cmY6AgfOdLzC_ajHvZ49PFSv_vb3TUMq3t_DIxc8HQHKZ6St3txnqnylLHtrOKiplt-YI9wDBHa05RkAn1ATZDGT48vMwOJXoKXkA-duccsWJhV1lHuFFlfcE8dSP9wG6UPvDRwC_lSmCTZg==));\nfirst-line non-small cell lung cancer (ROSETTA Lung-02, NCT06712316\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G52J9p6D2n9EIrt5TxB8vuNKdAgtdpupzIhJvurokJAOlqbrBr9ebSCrSdlzA5ocugRPUC-HU2Ieq5vrSjjjSumoGJTVRSMRtxqiIB_mXnrA-CHjuPx01pbgojrXP8fFfMlg6ygKtrh2bYlHZOgNKQxONmcwIe2rHRT7NR0FsANIrZLzGN195Nq9d6snUmNi7VuIyvxnHO9qdVWUo15TS_My4EN4Ulh2_vt2S9OYx6tYMCEeOt53CI-AdgyxBhOOALUHuL-fTO6BDLFksOh5OewMj9h-mph4CQqL8sZGqgUEdZ8LtuOacFc5IVj0TJfD_fXW3CykyyIFxwlVQaB1exzCNlqV6Ft6bqrftrL2xng8LdAABLS4RXf1rqUDBfidbdqMBb33JSuMKERIdH_FlNiaAF9y73e4G_CXrolZQax2W2Cp5kqNtu2MXP34c7u2EPw==));\nunresectable stage III non-small cell lung cancer (ROSETTA Lung-201,\nNCT07361497\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G58f44ypCn7vj5C_cTNXP7mlgT5BAbiqBsbhPijcQc0VL0lc7wBYVN04XAPGBpc4c_Z0QPg8Aasc9vsgliiepWXg-JcioHWTE83WZFb8GyK_QU9IdpFuyMyijKROp6TZiuhah6br6VcxTsEeMK0CNZKG-brL7l5oidXe6DDbx5GgTw8tqfAntXfRdMUKbSEjW-ofwbZ_8A2WDu5vwESDpRBw_NMrmKk4_Cjxy5M7oBhXf6Wwbfpbtwgs1t0iHV4b1u6xQ6CpV3MyVhab_WOxALuQc7OwNv7dTWOrOkox0a90HN7ykNcZzXAIY83TD2RK05yz6OOujJjO_KMPUmpqV7QZwmsm8mGOTSKXQvyuO5VLsJyupCZx2Ki4dgYI3a4hkFgq1TT_TnIZD7W77pgebqvKM3dGM-VicyiDAKbBwSIXPRwgPLV0cwGsyprMmmUZxFg==));\nfirst-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA\nLung-202, NCT07361510\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G5_JrOHSUvqxAiWIUZwio1LIEBpnHW9VLzR4xW1BRmSgUxUvh_wdhxDMzxwU2IeO5n_i6fOWxK1PhKe6S_TXxV8M1IsY1YlXMbJSdhKbvy09zyRCXN_zj1ud-MJKZSdKPUYbaFAnc6_d68AKPL829EHjGkKJNeqXcgUo8ZopMRO_XtHqqhPAmUTfjxh38U2-3OXkylyTPtxCKHekjqIhJiSM9PPYliEgwKvfnT7c3CK4pzH6xgq2nvShYVfq7P6G8GC6f5lwW2C2wLaZ4qrnlU_CH3XeRY9907tGXAA7ooOSr1y9WIKb8W8eVXwSMf_SQdn7ryDA3r5Vi1b4bON-kpmBkSzC_Yx8B6roPh1N6d2juPN_C-ASa9h5pSw6jaerP9JwzIcAr7WT_Q3IBRT_N0OGAH77OxaurAjG4usPhGDwhaLHJX7KBTJlcbkzbqNYJuQ==));\nfirst-line triple-negative breast cancer (ROSETTA Breast-01, NCT07173751\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G59SXIo-nTBvNiwPJxJL8Wj_gh1FLBOQUtLE0GhO8_SJPjZEJXIFLWYllptGmQCEPvu_wM9UJOVNTAUlERPoB7Yr3zPt8QiFpIOKPkaie1ECqaTgkxRsn6iyRLSWt8j648utmtBwMekBAPP3NDrZps1FpvQr2pIlBPqKzWRYYy4z9ZVR3OBiFPX2XUMKP2kMh3dlFLxiSQLl49PRVR9BKCpz0djW8MYTi3Qi3om-MoZnOTiasPgEEdb28InzQKw_hlcGn-yrWPfvh5p8oX-f-CcetwYv25FHdj7dAcm9Y90SE8Wl0qSoIw3BfZfcyw5iVA4_kxcX_AaLqoBYAI8_GNOgQmadm0FJ3l7vjGAHhuPQXeNLb4BLFIVhjQ2rBE7yM-VR5m7DNCPPEIuLlwCH0-Sk1UsQNtp-2ivsbOExqfZs2VDinHksrA6CRMyC98wd_8g==));\nfirst-line microsatellite stable colorectal cancer (ROSETTA CRC-203,\nNCT07221357\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G50PPm2SVDTYnSZUc0kaRUuVrCKeEynDnYZ9l24pMHu9zk_5LfFJGdcmzxsUF1b3t9-4xxhoEeZGld5celaQ1cY9D3n4LR_tTXH52mXVnKUCWcYVot3nVDUzePNJ44a4BTPk2f25SIHxWBJWy_yAQ_y824VtO66u8fGoawh6jZGkwZ5auUo0FcNY0vzFZ3JWNQ5UgULtIotkmJq2OzEwpoi7oOrSVXSSSzEpAzoh7Of7uQbUZeB8iVjkdkb6pq1Bl1iDGiqJxPIp9HkWGC4nIjpXfbKmL-yiW00zoPR0OV21Eo04Naj4KaYI6-SFPaqTp2fbtXHvCYL3xQwAvg2OIQpYwUrppaqroH5EXtnOw7CIiybPvB7BkgtZc95e71M0yPSyzKzT7bgILyDd1qRUvHiRPE-NCBDCaX-pbzrPscPOC_-1CUJyuYvGyX2Q05K_ROg==));\nand first-line gastric cancer (ROSETTA Gastric-204, NCT07221149\n(https://www.globenewswire.com/Tracker?data=OJfzQCvOeScj7XlZZS_G5-KDfyJdMec5T4bXeWphJ15p3saI9zHNmpmHJ9ZijsTsJGoEpcP1NohZ3DmyTCq0vdpFqGaKjtLicLW3JFd0upqtpGgExL1o6iohzc3OREucRTmeu3Fmly2rDVyPXqLiC30DySRqI2s-Uvf5t058FRB33gFD4v0S-g_njMQdBXhh8rhF2EmK5mB_srqSoKRF4CZRKBhDANHNlGM-MR6KyotSNkWJpdLnB73qvI7PQEFZmD_qjQaHRKeUTOy5E8ZRLgzGM-N9JPUEp_kNVrEz3MUa4PEW9SLC9HD2-iolxBjgrcFYjJXnO-J0hNjFU-hcNBeaEDr0XSRTB24imJlDT5KOxDZKsd6S4FsfSbjGnh0luFEmvuL3W5SNWiQ0fDPsB1qfHBxLA8qIdoQKnmGvD3LTeTwNMFo9TBxEqxa4oc6LFFbllGvzUOhSFvIWAU4gEw==)).\nPumitamig is also being explored in 10+ novel-novel combination trials with\nADCs and other novel modalities, with the aim of expanding its role across\ntumor types and identifying additional pivotal opportunities.\n\nAbout NSCLC\nNon-small cell lung cancer (NSCLC) covers all epithelial lung cancers other\nthan small cell lung cancer and includes squamous cell carcinoma, large cell\ncarcinoma, and adenocarcinoma of the lung. It is the most common type of lung\ncancer, accounting for approximately 85% of cases, and is the leading cause of\ncancer-related deaths worldwide.(2) Scientific advances have transformed the\ntreatment of NSCLC, improving outcomes for many patients. However, NSCLC\nremains an aggressive disease with a poor prognosis and a 5-year survival rate\nof 18 to 22% in advanced stages.(3) Patients with low levels of PD-L1\nexpression typically do not respond well to checkpoint inhibitor-based\nregimens creating a significant unmet need for new treatment options that\nprovide durable responses to a broad range of patients.\n\nAbout BioNTech\nBioNTech is a global next generation biopharmaceutical company pioneering\nnovel investigative therapies for cancer and other serious diseases. In\noncology, BioNTech is committed to transforming how cancer is treated. Its\nambition is to develop innovative medicines with pan-tumor or synergistic\npotential to address cancer from multiple angles and across the full continuum\nof the disease from early- to late-stage. Its growing late-stage oncology\npipeline comprises complementary treatment approaches spanning\nimmunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies.\nBioNTech has partnered with multiple global and specialized pharmaceutical\ncollaborators leveraging complementary expertise and resources to accelerate\ninnovation and drive progress, including Bristol Myers Squibb, Duality\nBiologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4,\nand Pfizer.\n\nFor more information, please visit www.BioNTech.com.\n\nBioNTech Forward-Looking Statements\nThis press release contains forward-looking statements within the meaning of\nthe Private Securities Litigation Reform Act of 1995, as amended, including,\nbut not limited to, statements concerning: BioNTech’s collaboration with\nBristol Myers Squibb (BMS); BioNTech and BMS’s ability to successfully\nco-develop and co-commercialize pumitamig (also known as BNT327 or BMS986545),\nif approved; the rate and degree of market acceptance of pumitamig, if\napproved; the initiation, timing, progress, and results of BioNTech’s\nresearch and development programs, including BioNTech’s current and future\nclinical trials, including statements regarding the expected timing of\ninitiation, enrollment, and completion of trials and related preparatory work\nand the availability of results, and the timing and outcome of applications\nfor regulatory approvals and marketing authorizations, including expectations\nregarding the potential indications in which pumitamig may be approved, if at\nall; the targeted timing and number of additional potentially registrational\ntrials, and the registrational potential of any trial BioNTech may initiate;\nand discussions with regulatory agencies. In some cases, forward-looking\nstatements can be identified by terminology such as “will,” “may,”\n“should,” “expects,” “intends,” “plans,” “aims,”\n“anticipates,” “believes,” “estimates,” “predicts,”\n“potential,” “continue,” or the negative of these terms or other\ncomparable terminology, although not all forward-looking statements contain\nthese words.\n\nThe forward-looking statements in this press release are based on BioNTech’s\ncurrent expectations and beliefs of future events and are neither promises nor\nguarantees. You should not place undue reliance on these forward-looking\nstatements because they involve known and unknown risks, uncertainties, and\nother factors, many of which are beyond BioNTech’s control and which could\ncause actual results to differ materially and adversely from those expressed\nor implied by these forward-looking statements. These risks and uncertainties\ninclude, but are not limited to: the uncertainties inherent in research and\ndevelopment, including the ability to meet anticipated clinical endpoints,\ncommencement and/or completion dates for clinical trials, regulatory\nsubmission dates, regulatory approval dates and/or launch dates, as well as\nrisks associated with clinical data, and including the possibility of\nunfavorable new preclinical, clinical or safety data and further analyses of\nexisting preclinical, clinical or safety data; the nature of clinical data,\nwhich is subject to ongoing peer review, regulatory review and market\ninterpretation; the impact of tariffs and escalations in trade policy;\ncompetition related to BioNTech’s product candidates; the timing of and\nBioNTech’s ability to obtain and maintain regulatory approval for its\nproduct candidates; BioNTech’s ability to identify research opportunities\nand discover and develop investigational medicines; the ability and\nwillingness of BioNTech’s third-party collaborators to continue research and\ndevelopment activities relating to BioNTech’s product candidates and\ninvestigational medicines; unforeseen safety issues and potential claims that\nare alleged to arise from the use of products and product candidates developed\nor manufactured by BioNTech; BioNTech’s and its collaborators’ ability to\ncommercialize and market its product candidates, if approved; BioNTech’s\nability to manage its development and related expenses; regulatory and\npolitical developments in the United States and other countries; BioNTech’s\nability to effectively scale its production capabilities and manufacture its\nproducts and product candidates; and other factors not known to BioNTech at\nthis time.\n\nYou should review the risks and uncertainties described under the heading\n“Risk Factors” in BioNTech’s Report on Form 6-K for the period ended\nJune 30, 2026 and in subsequent filings made by BioNTech with the SEC, which\nare available on the SEC’s website at www.sec.gov. These forward-looking\nstatements speak only as of the date hereof. Except as required by law,\nBioNTech disclaims any intention or responsibility for updating or revising\nany forward-looking statements contained in this press release in the event of\nnew information, future developments or otherwise.\n\nAbout Bristol Myers Squibb\nAt Bristol Myers Squibb, our mission is to discover, develop and deliver\ninnovative medicines that help patients prevail over serious diseases. We are\npursuing bold science to define what’s possible for the future of medicine\nand the patients we serve. For more information, visit us at BMS.com\n(https://www.globenewswire.com/Tracker?data=pD5llnupv3KxpW8LYEJsY7Ivd-wVKsNYX74qryuATuXVzzExu2ItfSjqL6fUzG9VoTlzxNGMaEZlAucEEBvvx6I_fsRdkS-K4UOLR7ScwsmqatK4zZ621oPvup7BKqO4rEvAXMcpN165aIPqS8eLg_2RKCUdLcBirbxHhkuUG0CMJeqpdwv_Ub_iyIMuoNPXVlVvNy-jCRhaDYozDK2RN0VN63n4odKC5_waH5XFaNpMKAcvMuKYJAcb-AiKkRcbm7s7m4pL7stUWbnizvJbUh7aITApc2_xqAUSs-SWwLg6A-BRRHdzYBr1Go54VjorcyU6CMi13JxvzKaraV-KbHT0rIuzwrRmiSZDX3eD21z1NPfuoJbfhePnuXUPkjurv43jWTEcSERFJkZmfaNBYg3EnHXh5RwssACemuYDIg9LjcRULiLwtoKD3VB109-Qp7oag84nOZ94plBpgIZpD157ouutEgA0JvekyWOUxarKKzhbpqZfFFZs3Yv4uvrAnNxyY9zEyC5w4YIsAkR1R-mansK6bzRGoudc35ppNYI75ZIsatVuFeFkZM0-d-EHMhuYglKDUbubw30kSd785J8h6wwZk7osq0M1XpATBRz7zNXf844lYcOAHFL0WhyJyOuOHh5WT-nemGbdsDaXdw==)\nand follow us on LinkedIn\n(https://www.globenewswire.com/Tracker?data=_mPPvG3IGmljxKf5WajbrxKO8tWYg9PaWjOCXRoyjceWUKepxpA4O__Zl6ukUkUv6tdAFC3u8htCtXyBUENSyWDyAdc1So4sNjuxRmEsKHgFpAU_VxSgHDsJEZcqWQFAbzP1Eir2qlV7-jw4jqiGitFPI0Rv1SHtnRyKSBq3R2To3DjCsXZ7jKteO9fMUpe106lhtX21p9mPkHyT3_qAYTubsNuszSyYTDKbqI-ZxlFE4rBLpDvqcen9JmW0vAwcxM9dqW9_Ca3Zcc1r89pL_ym_hYA0SeoMNoLTK3MwGzreFW87C-OQ4mNMwWPfthXdnSLWvwEcN2Zorq_i0ai1dEXsgInugGVIVvJjr6CcTzSoJAD2_COa6NJFMY7ACsnQUbhEeH7x6zWhq3n_W1IpV3D7ygu9CkmLtNT0YB0149L25WHnp4NrYC9_GAtZ4AcVz_RLotjtx8iTMfkwbJhuDQPo4_KvAx5m0bQ-LrNpm979F5FyQtD3hczpeLQfAZBdMLvufkYSmGkxynJOrsSrlQncgl_SxFcm1wZHByXtS8AfnBoj94mPjJ3WlG7O9r5BGn9icFrw0ZnT5ROdWyje0hopes_odtMR4Nm9Eujf3sXzxYlJ_pawn-i_M4XAnBQYKKjtLsVG7YP4wCSrYyqyZkeASaFDven-5voY_SUN8KkFBPDCPrMU4n_Vkd96thXF),\nX\n(https://www.globenewswire.com/Tracker?data=tHdLFK7BHZZjQj0mWOVgmcZrjHcoiwmpJ4ye3zSsnra7tMo41fJwVGbV31b-ljGoLKr7Ogv_sa34YyPn8C1vNm0evhjj3xArnUDW1aFHiJVCovKK90XyasANVB5lIeFyhzz_CLzpPHKvNPS57DfadMGR5wDwNerwlIGpdMgEbBHd6MzP75R9WmUaLN5vXh5gXBjTE3CiHHqlY277INZf-OOHOnI5ii_7HHLZCpLNqR4QAoBXDv559tLz_UViZn4IbKnNYRrClpytA4RR9wD9Ry-DiEfCPV2S8hJY-QuM56oIOrzptvLi47BaSzJD2kYtx9XNVJ62vVnJfECYGJ53bq14dcUSWlgk5KjXtgwEWdZe9sMnqSzPKB3k7hej2SqAR_E0A2h_eQ9XwOEDqMdBSFjJktgnkBf9u_umDwZ40vdhcqX928BAgG_VND4WKElxlYduYDQ_5W37561RSpTC2E1IGsjf6Jy_iawPpcpBRMks6LRV1OaYrqM-CSpie4nZ8BCxqXp5Bc_YfWoe0g2EnDN6v10AdWPkTjT9N2QGL4Z4Mrqyd_yBv9VtzHh8aHhiLsZPNtYiAd5SbRQ000MbCuVelZOoUCuWfUSJnPx0y4Yq_PaDQjgT5QUeyRX8IyIl),\nYouTube\n(https://www.globenewswire.com/Tracker?data=-sx42NDPOOFV-w11MAb6ubYhwOkqv94bRtce6hq7iLXdzLpAgEb4d6RlaKQvIdCHtcUI3ea1yOAtRtJZnf1E4OjmMra1cX6TeOp55bMuTR53YIx_uyL7NrxHu7YpTGAr772hzhRQa1xt3GjlcTiC3bFcJXf9nup2m4G8ghwXe_3H9bSA-fpEyuQ6yYPrqTrHFM40LweJwgg7DSDh7s3XpqrzcXc7dgd86G5eAQ-qH6GwtwzrAzcRiCXgkAk7zYsT3yfTOx9D0UphXwZLnToBoOrTngzehjLs0BuwHUn5wR0pPJSMqQ1fF5AqqEs1qyPHYUaJmyD9cymu7xyYM99_U5isSni4vPYXa8MRUftnj0oPB0fici100oARbQucG0vB4fb2Ob-8bbMZjCsCx3bmSbfVRv_O51VFbxGK6o_kR7y96zQsXJTUceXJ5MprVNQvi8lxU-WUK16sSu1WQquaRfd97wvaISp5S629t5gAYcNJRC-xINDVJLBIBSespqTD7F0BiloGedf-yn2_kGXD19Pz8LW-DqnX-PBeWFN46PGimH2HK2oRotFYZYi6Nt_wdX9cZ1n3CS3PCzZlS6qOOPdLyHqGuntj1kz1LJCQl8M9qGO6BZ1nmyrW_RI4oCGNr1_B0v0EhozkP3-c-auOK2zfOII1ztZEt5xTmpEbIFsPE7S5UIgefAI2UcXmFW5M),\nFacebook\n(https://www.globenewswire.com/Tracker?data=H6rMO12VUECSjVU7gTaXoondcpI5zgh0QvS2Pe8B582djTuhXY3OTYKjpLl1ARgZ47xQNM1JDuaEaWyHqyQnVgkpREE8Ke33DBJLdRX-HV_sRJ-C4rHcO7BZS7NQYuFClb6obEGyIpEsQsbYQrUlmMY3azfDZPuTfmiqm0r2PStPLDHQ5OzxKQdfVLE1ahXB3_-9dSqnEfypWGfplWb__KxUIXV7eUqZR3d79WmYVhXYLmKnkgjVsk5CvQlMyURT2yUzUPLRN9Y4MrM47lr-LWjn_M155fWAYb8DHY3vOzvFNkxUzhcjMVmRO54-XyF-an_w2ZjlTI8xoq2YqI3Cvg6QdrHOGVvOKDQrlz1sMjN4iy3-_3h737eKeC77MET6on7Os9mlFZnqCIaR14TgvoidK1dVOpnn2idojKYkeh6ZKDADm5H75aM7XD08x3TuGhSv9YDzYKuoeMM3_aExKccMl4e_FroXB1ySrOZ6rzQH2GU3nDv5nKYisAf_EZRjLTPtbVd9u4pWi7awG5KwSSm5kg3XL27R-zT-33gUTmGplnujU-1X7zLwWhSBDbOFfiS4SLVScW3FT_6IExUdSxgW9bdf2VdJJmJyfN5kJQ7NaCY99oE0m7_K8OAAB6wbhVH_XUaxuRZ1ItShFvHycm--9I8CM62C6U_4pxzZ82o=)\nand Instagram\n(https://www.globenewswire.com/Tracker?data=2CQpGHKHTPqqjxetbLH0g7KpRwVRg6JPeqnU4sHqiJYiaqyDMB1C7HIjPbvh3gTxh0wHVwGR1P_yhVCRCWPP5tWYG0v_0WwyZb0DwFfbUkNHmTcCTrC7KiuH0vE-yfUHVhfbtVljK0LgwWL6ZshL_WvxTIJg108ilHO8uq2qMaM6KE8QyiCNDT3LVyOxW0BAuwT13notc74en12vDmLlL_UUU3is1J8s2kDXXHVEP2QzcN30yeNISiqIg1OgRIzDX3kITckgdFWcPU2RxxV8y1Ornu8wRMR7MQNtJNt1GJ3bvZuYq_LciSGPRC81bwbgPTgPHTwtOs5Cgi1a-K8B6YBJp3RYJ7DiJ2X3YbWGA3QdXE3yV0N7Z64rnsMpU08uPozXOOnJb1fQvMnkakbiQzbMq4cKFzL9gMV0P3oSaVYPCBO4hT-5sopKXM-z3oIsVB4DMlHSuHzuSHgCtvFbRSSD2Er6k6wCjnZAwLYzwWWDL54Oq6bI00rN8Ds6KmqAHIXVet-_0k8p3e02FO659FWNuTsi2QHpOpP-XbnX5_11_mmKkzRTzo-bb4o0XzkUqZhdjZzpFfI_f4H-7jRPITSlWZz7XOKEuCkRwVBbxNdZsp2mYcqRz8FE6ApzbUEPCihutRJ_eVZAzyjqdQpthEAVAND3miqik_UYfGn8-AhjkX00FoYxg2QpH5gZgCdA).\n\nBristol Myers Squibb Cautionary Statement Regarding Forward-Looking Statements\nThis press release contains “forward-looking statements” within the\nmeaning of the Private Securities Litigation Reform Act of 1995 regarding,\namong other things, the research, development and commercialization of\npharmaceutical products. All statements that are not statements of historical\nfacts are, or may be deemed to be, forward-looking statements. Such\nforward-looking statements are based on current expectations and projections\nabout Bristol Myers Squibb’s future financial results, goals, plans and\nobjectives and involve inherent risks, assumptions and uncertainties,\nincluding internal or external factors that could delay, divert or change any\nof them in the next several years, that are difficult to predict, may be\nbeyond our control and could cause future financial results, goals, plans and\nobjectives to differ materially from those expressed in, or implied by, the\nstatements. These risks, assumptions, uncertainties and other factors include,\namong others, that the expected benefits of, and opportunities related to the\ncollaboration with BioNTech may not be realized by Bristol Myers Squibb or may\ntake longer to realize than anticipated, that future study results may not be\nconsistent with the results to date, that pumitamig (also known as BNT327 or\nBMS986545) alone or in combination with chemotherapy (such as docetaxel) may\nnot achieve its primary study endpoint or receive regulatory approval for the\nindications described in this release in the currently anticipated timeline or\nat all, any marketing approvals, if granted, may have significant limitations\non their use, and, if approved, whether pumitamig alone or in combination with\nchemotherapy will be commercially successful. No forward-looking statement can\nbe guaranteed. Forward-looking statements in this press release should be\nevaluated together with the many risks and uncertainties that affect Bristol\nMyers Squibb’s business and market, particularly those identified in the\ncautionary statement and risk factors discussion in Bristol Myers Squibb’s\nAnnual Report on Form 10-K for the year ended December 31, 2025, as updated by\nBristol Myers Squibb’s subsequent Quarterly Reports on Form 10-Q, Current\nReports on Form 8-K and other filings with the Securities and Exchange\nCommission. The forward-looking statements included in this document are made\nonly as of the date of this document and except as otherwise required by\napplicable law, Bristol Myers Squibb undertakes no obligation to publicly\nupdate or revise any forward-looking statement, whether as a result of new\ninformation, future events, changed circumstances or otherwise.\n\nCONTACTS\n\nBioNTech\nMedia Relations\nJasmina Alatovic\nMedia@biontech.de\n\nInvestor Relations\nDouglas Maffei, PhD\nInvestors@biontech.de\n\nBristol Myers Squibb\nMedia Relations\nmedia@bms.com  \n\nInvestor Relations\nInvestor.relations@bms.com\n\n1. Ahn MJ et al. J Clin Oncol. 2025;43(3):260–272.\n2. Lin Z et al. Medicine (Baltimore). 2025 Jul 25;104(30):e43300.\n3. Liu SV et al. Immunotherapy. 2025 Oct;17(14):1005-1013."},"type":"article","timestamp":"2026-10-25T07:29:59.960578701Z","server_sent_at_ms":1792913399960},"received_at":"2026-10-25T07:30:00.133Z","source_url":null},"analysis":{"id":"166850","press_release_id":"178947","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":["single-arm, open-label Phase 2 with only 30 efficacy-evaluable patients and short median follow-up (12.2 weeks) — no randomized control","median PFS CI extends to 'not reached'; immature survival data","grade ≥3 TRAEs in 18% and treatment discontinuation in 8% of patients"],"eventType":"clinical_trial","narrative":"Bristol Myers Squibb and BioNTech announced first data from the Phase 2 ROSETTA Lung-107 trial of pumitamig plus docetaxel in second-line metastatic NSCLC, presented as a late-breaker at ESMO 2026.\n\nAmong 30 efficacy-evaluable patients, the combination showed a confirmed objective response rate of 36.7% and disease control rate of 90.0%, with median PFS of 6.9 months versus roughly 3.6-3.9 months historically for standard-of-care docetaxel.\n\nResponses were consistent across PD-L1 expression levels and both squamous and non-squamous histologies, with a manageable safety profile and no new safety signals in 50 patients.\n\nThe data extend pumitamig into a high-unmet-need second-line setting and inform a broad development program including seven ongoing Phase 3 trials with registrational potential.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"Pumitamig nearly doubles median PFS vs docetaxel in tough second-line NSCLC — de-risks one of BMY's broadest Phase 3 pipeline bets."},"keyFigures":{"drugName":"pumitamig (BNT327/BMS986545)","phaseOfTrial":"Phase 2","customDimensions":{"confirmed_orr":"36.7%","grade3_trae_rate":"18.0%","patients_treated":50,"median_pfs_months":6.9,"six_month_pfs_rate":"63.3%","disease_control_rate":"90.0%","median_followup_weeks":12.2,"patients_efficacy_evaluable":30}},"quotedText":"This is the third global Phase 2 dataset to show consistent activity for pumitamig in lung cancer across PD-L1 expression levels, and it extends our evidence into a second-line setting where current options fall short","namedEntities":{"people":[{"name":"Byoung Chul Cho, M.D., Ph.D.","role":"Trial Investigator, Professor of Medical Oncology, Yonsei Cancer Center"},{"name":"Prof. Özlem Türeci, M.D.","role":"Co-Founder and Chief Medical Officer, BioNTech"},{"name":"Cristian Massacesi","role":"EVP, Chief Medical Officer and Head of Development, Bristol Myers Squibb"}],"products":["pumitamig","BNT327","BMS986545","docetaxel"],"companies":[{"name":"Bristol Myers Squibb","ticker":"BMY","relationship":"filer; co-developer of pumitamig"},{"name":"BioNTech SE","ticker":"BNTX","relationship":"partner; co-developer of pumitamig"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Positive Phase 2 data for jointly developed pipeline asset pumitamig in second-line NSCLC (cORR 36.7%, median PFS 6.9 months vs ~3.6-3.9 months historical docetaxel), strengthening a key co-development program with four ongoing Phase 3 trials. Encouraging but early, single-arm, small-n data — not yet a registrational or binary event."},"tickerRelevance":{"others":[{"ticker":"BNTX","relevance":"partner"}],"primary":"BMY"},"globalImportance":45,"audienceRelevance":55,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"large-cap","dataMaturity":"early-small-n","eventGravity":"positive-phase2-pipeline-data","partnershipAngle":"BNTX-BMY co-development","retailFavoriteBoost":"moderate (major oncology franchise)"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Bristol Myers Squibb and BioNTech announced first data from the Phase 2 ROSETTA Lung-107 trial of pumitamig plus docetaxel in second-line metastatic NSCLC, presented as a late-breaker at ESMO 2026.\n\nAmong 30 efficacy-evaluable patients, the combination showed a confirmed objective response rate of 36.7% and disease control rate of 90.0%, with median PFS of 6.9 months versus roughly 3.6-3.9 months historically for standard-of-care docetaxel.\n\nResponses were consistent across PD-L1 expression levels and both squamous and non-squamous histologies, with a manageable safety profile and no new safety signals in 50 patients.\n\nThe data extend pumitamig into a high-unmet-need second-line setting and inform a broad development program including seven ongoing Phase 3 trials with registrational potential.","key_figures":{"drugName":"pumitamig (BNT327/BMS986545)","phaseOfTrial":"Phase 2","customDimensions":{"confirmed_orr":"36.7%","grade3_trae_rate":"18.0%","patients_treated":50,"median_pfs_months":6.9,"six_month_pfs_rate":"63.3%","disease_control_rate":"90.0%","median_followup_weeks":12.2,"patients_efficacy_evaluable":30}},"named_entities":{"people":[{"name":"Byoung Chul Cho, M.D., Ph.D.","role":"Trial Investigator, Professor of Medical Oncology, Yonsei Cancer Center"},{"name":"Prof. Özlem Türeci, M.D.","role":"Co-Founder and Chief Medical Officer, BioNTech"},{"name":"Cristian Massacesi","role":"EVP, Chief Medical Officer and Head of Development, Bristol Myers Squibb"}],"products":["pumitamig","BNT327","BMS986545","docetaxel"],"companies":[{"name":"Bristol Myers Squibb","ticker":"BMY","relationship":"filer; co-developer of pumitamig"},{"name":"BioNTech SE","ticker":"BNTX","relationship":"partner; co-developer of pumitamig"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:5c812bd9e28b810d","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-25T07:30:06.844Z","global_importance":45,"audience_relevance":55,"importance_components":{"tickerTier":"large-cap","dataMaturity":"early-small-n","eventGravity":"positive-phase2-pipeline-data","partnershipAngle":"BNTX-BMY co-development","retailFavoriteBoost":"moderate (major oncology franchise)"}},"durationMs":6684,"modelName":"glm-5.3-flashx"}}