{"success":true,"data":{"pressRelease":{"id":"95689","rtpr_id":"nBw8Gh5BSa","ticker":"VSTM","exchange":"NASDAQ","all_tickers":["VSTM"],"title":"Verastem Oncology Doses First Patient in TARGET-D 202 Phase 2 Registration-Directed Trial of VS-7375 for KRAS G12D-Mutated Advanced Non-Small Cell Lung Cancer","author":"Business Wire","published_at":"2026-07-22T20:01:00.115Z","article_body":"Verastem Oncology Doses First Patient in TARGET-D 202 Phase 2\nRegistration-Directed Trial of VS-7375 for KRAS G12D-Mutated Advanced\nNon-Small Cell Lung Cancer\n\nTARGET-D 202 to evaluate VS-7375 as monotherapy at the RP2D of 900mg in\npatients with previously treated advanced non-small cell lung cancer\n\nA cohort in TARGET-D 202 will also evaluate VS-7375 in non-small cell lung\ncancer patients with asymptomatic untreated brain metastases\n\nApproximately 5% of patients with non-small cell lung cancer harbor a KRAS\nG12D mutation, yet no therapies specifically targeting KRAS G12D are\nFDA-approved for this patient population\n\nVerastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to\nadvancing new medicines for patients with RAS/MAPK pathway-driven cancers,\ntoday announced that the first patient has been dosed in the TARGET-D 202\nPhase 2 registration-directed trial evaluating VS-7375, an investigational\noral KRAS G12D (ON/OFF) inhibitor, in patients with previously treated KRAS\nG12D-mutated advanced non-small cell lung cancer (NSCLC). The initiation of\nTARGET-D 202 marks the second registration-directed Phase 2 clinical trial now\nunderway for VS-7375, following first-patient dosing in the TARGET-D 201\nmetastatic pancreatic cancer study announced last month.\n\n\"Despite advances in RAS-targeted therapies, there are no FDA-approved\ntherapies specifically designed to target KRAS G12D-mutated tumors. Among the\nmany challenges facing patients with KRAS G12D-mutated lung cancer, they\ncontinue to experience some of the poorest outcomes with progression-free\nsurvival of approximately 11 months – shorter than those with other common\nKRAS mutations,” said Michael Kauffman, M.D., Ph.D., president of\ndevelopment at Verastem Oncology. “We’re making significant progress with\nthe TARGET-D clinical trial programs, and once the first patient is dosed in\nthe TARGET-D 203 Phase 2 study for advanced metastatic colorectal cancer, we\nwill have registration-directed trials underway across the three most common\nKRAS G12D-driven tumor types. We believe we are well positioned to advance the\nbroad clinical development of VS-7375 across multiple tumor types to\nselectively target KRAS G12D to maximize efficacy, allow for tolerable\ncombinations, and avoid toxicities problematic with non-specific pan-RAS\ninhibitors.”\n\nTARGET-D 202 (NCT07659782\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07659782%3Fterm%3DVS-7375%26viewType%3DCard%26rank%3D1&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=NCT07659782&index=1&md5=4652000f9d2f798d2dbe4531ee4452c7)\n) is a global, open-label, Phase 2 registration-directed trial evaluating\nVS-7375 monotherapy at the recommended Phase 2 dose (RP2D) of 900 mg daily\n(QD) in patients with unresectable locally advanced or metastatic KRAS\nG12D-mutated NSCLC whose disease has progressed following prior treatment with\nplatinum-based chemotherapy and an anti-PD-(1) therapy. The trial is designed\nto evaluate the efficacy and safety of VS-7375 and support a potential\nregistration strategy in this patient population. A cohort in the study will\nalso evaluate VS-7375 in non-small cell lung cancer patients with asymptomatic\nuntreated brain metastases.\n\nIn June 2025, Verastem initiated TARGET-D 101, its Phase 1/2 dose escalation,\ndose expansion, and combination clinical trial evaluating the safety and\nefficacy of VS-7375 in patients with KRAS G12D-mutated metastatic pancreatic\nductal carcinoma (mPDAC), metastatic colorectal cancer (mCRC), NSCLC, and\nother solid tumor cancers. In a recent update\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fvs-7375-demonstrates-clinical-activity-favorable-safety-and&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=update&index=2&md5=9c53eb4f2d0f6d46a0eec6686d6c7192)\n, the Company shared that VS-7375 demonstrated encouraging anti-tumor activity\nacross multiple KRAS G12D-driven tumor types, including mPDAC, mCRC, and\nadvanced NSCLC, with evidence of dose-dependent activity, favorable PK\nsupporting target exposure, and a favorable and manageable safety and\ntolerability profile. Patient follow-up continues to mature across monotherapy\nand combination cohorts, and the Company expects to share an update in the\nsecond half of 2026.\n\nAbout Non-Small Cell Lung Cancer\n\nLung cancer remains the leading cause of cancer-related death worldwide, with\nnon-small cell lung cancer (NSCLC) accounting for approximately 80–85% of\nall lung cancer diagnoses. Approximately 10,000 patients with NSCLC harbor a\nKRAS G12D mutation in the U.S. annually. Compared with other KRAS mutation\nvariants, metastatic KRAS G12D NSCLC is associated with the shortest\nprogression-free survival and has been linked to immune suppression and\nresistance to anti-PD-(L)1 therapies. KRAS G12D is the most common KRAS\nmutation among never-smokers, while also occurring in many patients with a\nhistory of smoking. Additionally, brain metastases remain a significant\nclinical challenge in metastatic NSCLC, affecting approximately 10–20% of\npatients at diagnosis and up to 40% during the course of disease. Despite\nthese challenges and the significant unmet medical need, there are currently\nno approved therapies specifically targeting KRAS G12D-mutated NSCLC.\n\nAbout KRAS G12D\n\nKRAS G12D represents 26% of all KRAS mutations, making it the most prevalent\nKRAS mutation in human cancers. When the KRAS gene is mutated, it can promote\ncancer development and growth. Patients with KRAS G12D-mutant tumors often\nhave poorer outcomes, underscoring the need for therapies designed\nspecifically to inhibit this mutation potently and for a long duration. The\nKRAS G12D mutation occurs most commonly in pancreatic (40%), colorectal (15%),\nendometrial (8%), biliary tract (7-15%), and non-small cell lung (5%) cancers.\nCurrently, no therapies are approved by the U.S. Food and Drug Administration\n(FDA) specifically targeting KRAS G12D mutations in cancer.\n\nAbout VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor & TARGET-D Clinical\nProgram\n\nVS-7375\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.verastem.com%2Four-science%2Fkras-g12d-inhibition%2F&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=VS-7375&index=3&md5=9323e72268f974de27240263873711f6)\nis a potential best-in-class, potent, and selective investigational oral KRAS\nG12D dual ON/OFF inhibitor. It is designed to uniquely bind to both the active\n(ON) and inactive (OFF) states of KRAS G12D, with the potential to inhibit\nKRAS G12D signaling and tumor growth more completely than compounds that block\nKRAS G12D only in the OFF state or only in the ON state.\n\nIn June 2025\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-announces-first-patient-dosed-vs-7375-oral&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=In+June+2025&index=4&md5=6f0768f56e90d72b0304335523ddf43a)\n, Verastem initiated TARGET-D 101, a Phase 1/2 dose escalation, dose\nexpansion, and combination clinical trial evaluating the safety and efficacy\nof VS-7375 in patients with KRAS G12D-mutated metastatic pancreatic ductal\ncarcinoma (mPDAC), metastatic colorectal cancer (mCRC), advanced non-small\ncell lung cancer (NSCLC), and other solid tumors. Verastem has further\nexpanded the VS-7375 clinical program with the initiation of three Phase 2\nregistration-directed, open-label clinical trials: TARGET-D 201 (NCT07644559\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07644559%3Fintr%3DVS-7375%26viewType%3DCard%26rank%3D2&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=NCT07644559&index=5&md5=19317a8acc1f51c7547846f3eaee72e9)\n) in second-line advanced or metastatic PDAC, TARGET-D 202 (NCT07659782\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07659782%3Fintr%3Dvs-7375%26viewType%3DCard%26rank%3D1&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=NCT07659782&index=6&md5=f10da87c48ac30bbc879ca57994b8605)\n) in second/third-line advanced or metastatic NSCLC, and TARGET-D 203\n(NCT07659795\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07659795%3Fintr%3Dvs-7375%26viewType%3DCard%26rank%3D3&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=NCT07659795&index=7&md5=a53c632aa3a00e07b73c59a1ffd0c9f9)\n) in metastatic CRC. In June 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-doses-first-patient-target-d-201-phase-2&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=June+2026&index=8&md5=43679f0e37cbcc5fb8312774edb8a8b1)\n, the company announced the first patient was dosed in the TARGET-D 201 trial.\n\nIn July 2025\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-granted-fast-track-designation-vs-7375&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=In+July+2025&index=9&md5=b612c255994a373e4faaeb4f67bf0eae)\n, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD)\nto VS-7375 for the first-line treatment of patients with KRAS G12D-mutated\nlocally advanced or metastatic adenocarcinoma of the pancreas and for the\ntreatment of patients with KRAS G12D-mutated locally advanced or metastatic\npancreatic ductal carcinoma who have received at least one prior line of\nstandard systemic therapy. In June 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-announces-us-fda-fast-track-designation-vs&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=In+June+2026&index=10&md5=2ac19851da4a160e1c852b8c8f9d2152)\n, the FDA also granted FTD to VS-7375 for the treatment of adult patients with\nKRAS G12D-mutated unresectable locally advanced or metastatic non-small cell\nlung cancer (NSCLC) who have received platinum-based chemotherapy and an\nanti-PD-(L)1 antibody either concurrently or sequentially.\n\nIn December 2023\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-selects-oral-kras-g12d-inhibitor-gfh375vs-7375&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=In+December+2023&index=11&md5=e98b15fc025119728a3bb7dfe85bc301)\n, Verastem selected VS-7375 as its lead program from its collaboration with\nGenFleet Therapeutics, which aims to advance three oncology discovery programs\nrelated to RAS/MAPK pathway-driven cancers. The collaboration provides\nVerastem with an exclusive option to obtain a license for each of the three\ncompounds in the collaboration after the successful completion of\npre-determined milestones in a Phase 1 trial. In January 2025\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-exercises-option-early-license-vs-7375-oral&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=In+January+2025&index=12&md5=2fdf8e6372f2d9316aa961b45c20526a)\n, Verastem exercised its license for VS-7375. The licenses would give Verastem\ndevelopment and commercialization rights outside the GenFleet markets of\nmainland China, Hong Kong, Macau, and Taiwan. GenFleet is developing VS-7375\nas GFH375 in China.\n\nAbout Verastem Oncology\n\nVerastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to\ndeveloping and commercializing new medicines to improve the lives of patients\ndiagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI(®)\nFAKZYNJA(®) CO-PACK in the U.S. Our pipeline is focused on novel small\nmolecule drugs that inhibit critical signaling pathways in cancer that promote\ncancer cell survival and tumor growth, including RAF/MEK inhibition, FAK\ninhibition, and KRAS G12D inhibition. For more information, please visit\nwww.verastem.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.verastem.com%2F&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=www.verastem.com&index=13&md5=6590db7c929b5f176bb89d1749e1981f)\nand follow us on LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fverastemoncology&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=LinkedIn&index=14&md5=8b1675d8e3e9b87b229ab3bdda3b3d1b)\n.\n\nForward-Looking Statements\n\nThis press release includes forward-looking statements. These forward-looking\nstatements generally can be identified by the use of words such as\n“anticipate,” “expect,” “plan,” “could,” “may,”\n“believe,” “estimate,” “forecast,” “goal,” “project,” and\nother words of similar meaning. Such forward-looking statements address\nvarious matters about, among other things, Verastem Oncology’s programs and\nproduct candidates, strategy, future plans and prospects, including statements\nrelated to the potential for and timing of commercialization of product\ncandidates, the anticipated timing for any amendments to the IND application\nfor VS-7375/GFH375, the expected outcome and benefits of the Company’s\ncollaboration with GenFleet Therapeutics (Shanghai), Inc., the timing of\ncommencing and completing trials and compiling data, the expected timing of\nthe presentation of data by the Company and the potential clinical value of\nvarious of the Company’s clinical trials. Each forward-looking statement\ncontained in this press release is subject to risks and uncertainties that\ncould cause actual results to differ materially from those expressed or\nimplied by such statement. Applicable risks and uncertainties include, among\nothers: the uncertainties inherent in research and development, such as the\npossibility of negative or unexpected results of clinical trials; that we may\nnot see a return on investment on the payments we have and may continue to\nmake pursuant to the collaboration and option agreement with GenFleet, or that\nGenFleet may fail to fully perform under the agreement; that we may not be\nsuccessful in our continued commercialization of AVMAPKI FAKZYNJA CO-PACK;\nthat the development and commercialization of our product candidates may take\nlonger or cost more than planned, including as a result of conducting\nadditional studies or our decisions regarding execution of such\ncommercialization; that data may not be available when expected; risks\nassociated with preliminary and interim data, which may not be representative\nof more mature data; risks associated with the regulatory and policy actions\nproposed and enacted by the current U.S. presidential administration that may\nadversely affect our business; risks associated with the current\nadministration’s reductions to the FDA’s workforce and any subsequent\nreductions that may lead to disruptions and delays in the FDA’s review and\noversight of our product candidates and impact the FDA’s ability to provide\ntimely feedback on our development programs; that our product candidates may\nnot receive regulatory approval, become commercially successful products, or\nresult in new treatment options being offered to patients; and the risks\nidentified under the heading \"Risk Factors\" as detailed in the Company’s\nAnnual Report on Form 10-K for the year ended December 31, 2025, as filed with\nthe Securities and Exchange Commission (SEC) on March 4, 2026, as well as the\nother information we file with the SEC, are possibly realized. We caution\ninvestors not to place considerable reliance on the forward-looking statements\ncontained in this press release. You are encouraged to read our filings with\nthe SEC, available at www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=www.sec.gov&index=15&md5=046440fb7c0a953db97f907732867d36)\n, for a discussion of these and other risks and uncertainties. The\nforward-looking statements in this press release speak only as of the date of\nthis press release, and we undertake no obligation to update or revise any of\nthese statements. Our business is subject to substantial risks and\nuncertainties, including those referenced above. Investors, potential\ninvestors, and others should give careful consideration to these risks and\nuncertainties.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260722569516/en/\n(https://www.businesswire.com/news/home/20260722569516/en/)\n\nFor Investor and Media Inquiries: \n\nJulissa Viana\n\nSenior Vice President, Corporate Communications,\n\nInvestor Relations & Patient Advocacy\n\ninvestors@verastem.com (mailto:investors@verastem.com) or\n\nmedia@verastem.com (mailto:media@verastem.com)\n\n\nCopyright Business Wire 2026","article_body_html":"","raw_payload":{"data":{"id":"nBw8Gh5BSa","title":"Verastem Oncology Doses First Patient in TARGET-D 202 Phase 2 Registration-Directed Trial of VS-7375 for KRAS G12D-Mutated Advanced Non-Small Cell Lung Cancer","author":"Business Wire","ticker":"VSTM","created":"2026-07-22T20:01:00.115Z","tickers":["VSTM"],"exchange":"NASDAQ","article_body":"Verastem Oncology Doses First Patient in TARGET-D 202 Phase 2\nRegistration-Directed Trial of VS-7375 for KRAS G12D-Mutated Advanced\nNon-Small Cell Lung Cancer\n\nTARGET-D 202 to evaluate VS-7375 as monotherapy at the RP2D of 900mg in\npatients with previously treated advanced non-small cell lung cancer\n\nA cohort in TARGET-D 202 will also evaluate VS-7375 in non-small cell lung\ncancer patients with asymptomatic untreated brain metastases\n\nApproximately 5% of patients with non-small cell lung cancer harbor a KRAS\nG12D mutation, yet no therapies specifically targeting KRAS G12D are\nFDA-approved for this patient population\n\nVerastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to\nadvancing new medicines for patients with RAS/MAPK pathway-driven cancers,\ntoday announced that the first patient has been dosed in the TARGET-D 202\nPhase 2 registration-directed trial evaluating VS-7375, an investigational\noral KRAS G12D (ON/OFF) inhibitor, in patients with previously treated KRAS\nG12D-mutated advanced non-small cell lung cancer (NSCLC). The initiation of\nTARGET-D 202 marks the second registration-directed Phase 2 clinical trial now\nunderway for VS-7375, following first-patient dosing in the TARGET-D 201\nmetastatic pancreatic cancer study announced last month.\n\n\"Despite advances in RAS-targeted therapies, there are no FDA-approved\ntherapies specifically designed to target KRAS G12D-mutated tumors. Among the\nmany challenges facing patients with KRAS G12D-mutated lung cancer, they\ncontinue to experience some of the poorest outcomes with progression-free\nsurvival of approximately 11 months – shorter than those with other common\nKRAS mutations,” said Michael Kauffman, M.D., Ph.D., president of\ndevelopment at Verastem Oncology. “We’re making significant progress with\nthe TARGET-D clinical trial programs, and once the first patient is dosed in\nthe TARGET-D 203 Phase 2 study for advanced metastatic colorectal cancer, we\nwill have registration-directed trials underway across the three most common\nKRAS G12D-driven tumor types. We believe we are well positioned to advance the\nbroad clinical development of VS-7375 across multiple tumor types to\nselectively target KRAS G12D to maximize efficacy, allow for tolerable\ncombinations, and avoid toxicities problematic with non-specific pan-RAS\ninhibitors.”\n\nTARGET-D 202 (NCT07659782\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07659782%3Fterm%3DVS-7375%26viewType%3DCard%26rank%3D1&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=NCT07659782&index=1&md5=4652000f9d2f798d2dbe4531ee4452c7)\n) is a global, open-label, Phase 2 registration-directed trial evaluating\nVS-7375 monotherapy at the recommended Phase 2 dose (RP2D) of 900 mg daily\n(QD) in patients with unresectable locally advanced or metastatic KRAS\nG12D-mutated NSCLC whose disease has progressed following prior treatment with\nplatinum-based chemotherapy and an anti-PD-(1) therapy. The trial is designed\nto evaluate the efficacy and safety of VS-7375 and support a potential\nregistration strategy in this patient population. A cohort in the study will\nalso evaluate VS-7375 in non-small cell lung cancer patients with asymptomatic\nuntreated brain metastases.\n\nIn June 2025, Verastem initiated TARGET-D 101, its Phase 1/2 dose escalation,\ndose expansion, and combination clinical trial evaluating the safety and\nefficacy of VS-7375 in patients with KRAS G12D-mutated metastatic pancreatic\nductal carcinoma (mPDAC), metastatic colorectal cancer (mCRC), NSCLC, and\nother solid tumor cancers. In a recent update\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fvs-7375-demonstrates-clinical-activity-favorable-safety-and&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=update&index=2&md5=9c53eb4f2d0f6d46a0eec6686d6c7192)\n, the Company shared that VS-7375 demonstrated encouraging anti-tumor activity\nacross multiple KRAS G12D-driven tumor types, including mPDAC, mCRC, and\nadvanced NSCLC, with evidence of dose-dependent activity, favorable PK\nsupporting target exposure, and a favorable and manageable safety and\ntolerability profile. Patient follow-up continues to mature across monotherapy\nand combination cohorts, and the Company expects to share an update in the\nsecond half of 2026.\n\nAbout Non-Small Cell Lung Cancer\n\nLung cancer remains the leading cause of cancer-related death worldwide, with\nnon-small cell lung cancer (NSCLC) accounting for approximately 80–85% of\nall lung cancer diagnoses. Approximately 10,000 patients with NSCLC harbor a\nKRAS G12D mutation in the U.S. annually. Compared with other KRAS mutation\nvariants, metastatic KRAS G12D NSCLC is associated with the shortest\nprogression-free survival and has been linked to immune suppression and\nresistance to anti-PD-(L)1 therapies. KRAS G12D is the most common KRAS\nmutation among never-smokers, while also occurring in many patients with a\nhistory of smoking. Additionally, brain metastases remain a significant\nclinical challenge in metastatic NSCLC, affecting approximately 10–20% of\npatients at diagnosis and up to 40% during the course of disease. Despite\nthese challenges and the significant unmet medical need, there are currently\nno approved therapies specifically targeting KRAS G12D-mutated NSCLC.\n\nAbout KRAS G12D\n\nKRAS G12D represents 26% of all KRAS mutations, making it the most prevalent\nKRAS mutation in human cancers. When the KRAS gene is mutated, it can promote\ncancer development and growth. Patients with KRAS G12D-mutant tumors often\nhave poorer outcomes, underscoring the need for therapies designed\nspecifically to inhibit this mutation potently and for a long duration. The\nKRAS G12D mutation occurs most commonly in pancreatic (40%), colorectal (15%),\nendometrial (8%), biliary tract (7-15%), and non-small cell lung (5%) cancers.\nCurrently, no therapies are approved by the U.S. Food and Drug Administration\n(FDA) specifically targeting KRAS G12D mutations in cancer.\n\nAbout VS-7375, an Oral KRAS G12D (ON/OFF) Inhibitor & TARGET-D Clinical\nProgram\n\nVS-7375\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.verastem.com%2Four-science%2Fkras-g12d-inhibition%2F&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=VS-7375&index=3&md5=9323e72268f974de27240263873711f6)\nis a potential best-in-class, potent, and selective investigational oral KRAS\nG12D dual ON/OFF inhibitor. It is designed to uniquely bind to both the active\n(ON) and inactive (OFF) states of KRAS G12D, with the potential to inhibit\nKRAS G12D signaling and tumor growth more completely than compounds that block\nKRAS G12D only in the OFF state or only in the ON state.\n\nIn June 2025\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-announces-first-patient-dosed-vs-7375-oral&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=In+June+2025&index=4&md5=6f0768f56e90d72b0304335523ddf43a)\n, Verastem initiated TARGET-D 101, a Phase 1/2 dose escalation, dose\nexpansion, and combination clinical trial evaluating the safety and efficacy\nof VS-7375 in patients with KRAS G12D-mutated metastatic pancreatic ductal\ncarcinoma (mPDAC), metastatic colorectal cancer (mCRC), advanced non-small\ncell lung cancer (NSCLC), and other solid tumors. Verastem has further\nexpanded the VS-7375 clinical program with the initiation of three Phase 2\nregistration-directed, open-label clinical trials: TARGET-D 201 (NCT07644559\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07644559%3Fintr%3DVS-7375%26viewType%3DCard%26rank%3D2&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=NCT07644559&index=5&md5=19317a8acc1f51c7547846f3eaee72e9)\n) in second-line advanced or metastatic PDAC, TARGET-D 202 (NCT07659782\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07659782%3Fintr%3Dvs-7375%26viewType%3DCard%26rank%3D1&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=NCT07659782&index=6&md5=f10da87c48ac30bbc879ca57994b8605)\n) in second/third-line advanced or metastatic NSCLC, and TARGET-D 203\n(NCT07659795\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fclinicaltrials.gov%2Fstudy%2FNCT07659795%3Fintr%3Dvs-7375%26viewType%3DCard%26rank%3D3&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=NCT07659795&index=7&md5=a53c632aa3a00e07b73c59a1ffd0c9f9)\n) in metastatic CRC. In June 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-doses-first-patient-target-d-201-phase-2&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=June+2026&index=8&md5=43679f0e37cbcc5fb8312774edb8a8b1)\n, the company announced the first patient was dosed in the TARGET-D 201 trial.\n\nIn July 2025\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-granted-fast-track-designation-vs-7375&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=In+July+2025&index=9&md5=b612c255994a373e4faaeb4f67bf0eae)\n, U.S. Food and Drug Administration (FDA) granted Fast Track Designation (FTD)\nto VS-7375 for the first-line treatment of patients with KRAS G12D-mutated\nlocally advanced or metastatic adenocarcinoma of the pancreas and for the\ntreatment of patients with KRAS G12D-mutated locally advanced or metastatic\npancreatic ductal carcinoma who have received at least one prior line of\nstandard systemic therapy. In June 2026\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-announces-us-fda-fast-track-designation-vs&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=In+June+2026&index=10&md5=2ac19851da4a160e1c852b8c8f9d2152)\n, the FDA also granted FTD to VS-7375 for the treatment of adult patients with\nKRAS G12D-mutated unresectable locally advanced or metastatic non-small cell\nlung cancer (NSCLC) who have received platinum-based chemotherapy and an\nanti-PD-(L)1 antibody either concurrently or sequentially.\n\nIn December 2023\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-selects-oral-kras-g12d-inhibitor-gfh375vs-7375&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=In+December+2023&index=11&md5=e98b15fc025119728a3bb7dfe85bc301)\n, Verastem selected VS-7375 as its lead program from its collaboration with\nGenFleet Therapeutics, which aims to advance three oncology discovery programs\nrelated to RAS/MAPK pathway-driven cancers. The collaboration provides\nVerastem with an exclusive option to obtain a license for each of the three\ncompounds in the collaboration after the successful completion of\npre-determined milestones in a Phase 1 trial. In January 2025\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Finvestor.verastem.com%2Fnews-releases%2Fnews-release-details%2Fverastem-oncology-exercises-option-early-license-vs-7375-oral&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=In+January+2025&index=12&md5=2fdf8e6372f2d9316aa961b45c20526a)\n, Verastem exercised its license for VS-7375. The licenses would give Verastem\ndevelopment and commercialization rights outside the GenFleet markets of\nmainland China, Hong Kong, Macau, and Taiwan. GenFleet is developing VS-7375\nas GFH375 in China.\n\nAbout Verastem Oncology\n\nVerastem Oncology (Nasdaq: VSTM) is a biopharmaceutical company committed to\ndeveloping and commercializing new medicines to improve the lives of patients\ndiagnosed with RAS/MAPK pathway-driven cancers. Verastem markets AVMAPKI(®)\nFAKZYNJA(®) CO-PACK in the U.S. Our pipeline is focused on novel small\nmolecule drugs that inhibit critical signaling pathways in cancer that promote\ncancer cell survival and tumor growth, including RAF/MEK inhibition, FAK\ninhibition, and KRAS G12D inhibition. For more information, please visit\nwww.verastem.com\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.verastem.com%2F&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=www.verastem.com&index=13&md5=6590db7c929b5f176bb89d1749e1981f)\nand follow us on LinkedIn\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=https%3A%2F%2Fwww.linkedin.com%2Fcompany%2Fverastemoncology&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=LinkedIn&index=14&md5=8b1675d8e3e9b87b229ab3bdda3b3d1b)\n.\n\nForward-Looking Statements\n\nThis press release includes forward-looking statements. These forward-looking\nstatements generally can be identified by the use of words such as\n“anticipate,” “expect,” “plan,” “could,” “may,”\n“believe,” “estimate,” “forecast,” “goal,” “project,” and\nother words of similar meaning. Such forward-looking statements address\nvarious matters about, among other things, Verastem Oncology’s programs and\nproduct candidates, strategy, future plans and prospects, including statements\nrelated to the potential for and timing of commercialization of product\ncandidates, the anticipated timing for any amendments to the IND application\nfor VS-7375/GFH375, the expected outcome and benefits of the Company’s\ncollaboration with GenFleet Therapeutics (Shanghai), Inc., the timing of\ncommencing and completing trials and compiling data, the expected timing of\nthe presentation of data by the Company and the potential clinical value of\nvarious of the Company’s clinical trials. Each forward-looking statement\ncontained in this press release is subject to risks and uncertainties that\ncould cause actual results to differ materially from those expressed or\nimplied by such statement. Applicable risks and uncertainties include, among\nothers: the uncertainties inherent in research and development, such as the\npossibility of negative or unexpected results of clinical trials; that we may\nnot see a return on investment on the payments we have and may continue to\nmake pursuant to the collaboration and option agreement with GenFleet, or that\nGenFleet may fail to fully perform under the agreement; that we may not be\nsuccessful in our continued commercialization of AVMAPKI FAKZYNJA CO-PACK;\nthat the development and commercialization of our product candidates may take\nlonger or cost more than planned, including as a result of conducting\nadditional studies or our decisions regarding execution of such\ncommercialization; that data may not be available when expected; risks\nassociated with preliminary and interim data, which may not be representative\nof more mature data; risks associated with the regulatory and policy actions\nproposed and enacted by the current U.S. presidential administration that may\nadversely affect our business; risks associated with the current\nadministration’s reductions to the FDA’s workforce and any subsequent\nreductions that may lead to disruptions and delays in the FDA’s review and\noversight of our product candidates and impact the FDA’s ability to provide\ntimely feedback on our development programs; that our product candidates may\nnot receive regulatory approval, become commercially successful products, or\nresult in new treatment options being offered to patients; and the risks\nidentified under the heading \"Risk Factors\" as detailed in the Company’s\nAnnual Report on Form 10-K for the year ended December 31, 2025, as filed with\nthe Securities and Exchange Commission (SEC) on March 4, 2026, as well as the\nother information we file with the SEC, are possibly realized. We caution\ninvestors not to place considerable reliance on the forward-looking statements\ncontained in this press release. You are encouraged to read our filings with\nthe SEC, available at www.sec.gov\n(https://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sec.gov&esheet=54575225&newsitemid=20260722569516&lan=en-US&anchor=www.sec.gov&index=15&md5=046440fb7c0a953db97f907732867d36)\n, for a discussion of these and other risks and uncertainties. The\nforward-looking statements in this press release speak only as of the date of\nthis press release, and we undertake no obligation to update or revise any of\nthese statements. Our business is subject to substantial risks and\nuncertainties, including those referenced above. Investors, potential\ninvestors, and others should give careful consideration to these risks and\nuncertainties.\n\n\n\nView source version on businesswire.com:\nhttps://www.businesswire.com/news/home/20260722569516/en/\n(https://www.businesswire.com/news/home/20260722569516/en/)\n\nFor Investor and Media Inquiries: \n\nJulissa Viana\n\nSenior Vice President, Corporate Communications,\n\nInvestor Relations & Patient Advocacy\n\ninvestors@verastem.com (mailto:investors@verastem.com) or\n\nmedia@verastem.com (mailto:media@verastem.com)\n\n\nCopyright Business Wire 2026"},"type":"article","timestamp":"2026-07-22T20:01:00.185147869Z","server_sent_at_ms":1784750460185},"received_at":"2026-07-22T20:01:00.277Z","source_url":"https://www.businesswire.com/news/home/20260722569516/en/"},"analysis":{"id":"84736","press_release_id":"95689","analysis_json":{"industry":{"label":"Biotechnology","sector":"Health Care"},"redFlags":[],"eventType":"clinical_trial","narrative":"Verastem Oncology announced the dosing of the first patient in the TARGET-D 202 Phase 2 registration-directed trial of VS-7375 for KRAS G12D-mutated advanced non-small cell lung cancer.\n\nThe trial will evaluate VS-7375 monotherapy at 900 mg daily in previously treated patients, including a specific cohort for those with asymptomatic untreated brain metastases.\n\nThis marks the second registration-directed Phase 2 trial for VS-7375, following the pancreatic cancer study, with a clinical update expected in the second half of 2026.","sentiment":"bullish","agentHooks":{"shouldPost":true,"suggestedAngle":"VS-7375 advances into second registration-directed Phase 2 trial for KRAS G12D-mutated NSCLC."},"keyFigures":{"drugName":"VS-7375","phaseOfTrial":"Phase 2","customDimensions":{"dose":"900 mg daily","trial_id":"NCT07659782","us_annual_incidence":"10,000 patients","nsclc_mutation_prevalence":"5%"}},"quotedText":"We believe we are well positioned to advance the broad clinical development of VS-7375 across multiple tumor types to selectively target KRAS G12D to maximize efficacy, allow for tolerable combinations, and avoid toxicities problematic with non-specific pan-RAS inhibitors.","namedEntities":{"people":[{"name":"Michael Kauffman","role":"President of Development"}],"products":["VS-7375","AVMAPKI FAKZYNJA CO-PACK"],"companies":[{"name":"Verastem Oncology","ticker":"VSTM"},{"name":"GenFleet Therapeutics","relationship":"collaborator"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"Initiating a registration-directed Phase 2 trial for the lead asset in a second indication (NSCLC) is a significant clinical de-risking milestone. However, as a 'first patient dosed' announcement rather than data readout or regulatory approval, it represents an intermediate execution step."},"tickerRelevance":{"others":[],"primary":"VSTM"},"globalImportance":25,"audienceRelevance":30,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"small-mid_cap_biotech","unmet_need":"high","eventGravity":"registration_directed_phase_2_initiation"}},"event_type":"clinical_trial","event_type_secondary":null,"sentiment":"bullish","material_impact_score":3,"narrative":"Verastem Oncology announced the dosing of the first patient in the TARGET-D 202 Phase 2 registration-directed trial of VS-7375 for KRAS G12D-mutated advanced non-small cell lung cancer.\n\nThe trial will evaluate VS-7375 monotherapy at 900 mg daily in previously treated patients, including a specific cohort for those with asymptomatic untreated brain metastases.\n\nThis marks the second registration-directed Phase 2 trial for VS-7375, following the pancreatic cancer study, with a clinical update expected in the second half of 2026.","key_figures":{"drugName":"VS-7375","phaseOfTrial":"Phase 2","customDimensions":{"dose":"900 mg daily","trial_id":"NCT07659782","us_annual_incidence":"10,000 patients","nsclc_mutation_prevalence":"5%"}},"named_entities":{"people":[{"name":"Michael Kauffman","role":"President of Development"}],"products":["VS-7375","AVMAPKI FAKZYNJA CO-PACK"],"companies":[{"name":"Verastem Oncology","ticker":"VSTM"},{"name":"GenFleet Therapeutics","relationship":"collaborator"},{"name":"U.S. Food and Drug Administration","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-4.7","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-07-22T20:58:27.861Z","global_importance":25,"audience_relevance":30,"importance_components":{"tickerTier":"small-mid_cap_biotech","unmet_need":"high","eventGravity":"registration_directed_phase_2_initiation"}},"durationMs":308152,"modelName":"glm-4.7"}}