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VSTM 資訊
VSTM 事件
Verastem Oncology Reports Positive Preliminary Data for VS-7375 Clinical Trial
Verastem Oncology announced positive preliminary data from the ongoing TARGET-D 101 Phase 1/2 clinical trial evaluating VS-7375, an investigational oral KRAS G12D inhibitor, with best-in-class potential, in patients with advanced KRAS G12D-mutated solid tumors. The data demonstrate encouraging clinical activity along with a favorable safety and tolerability profile across multiple dose levels and tumor types, including metastatic pancreatic ductal carcinoma, metastatic colorectal cancer, and advanced non-small cell lung cancer. "VS-7375 has demonstrated anti-tumor activity across multiple dose levels and tumor types, encouraging signals from rational combination strategies, and a favorable safety profile that improves meaningfully beyond the first treatment cycle, underscoring its potential to be not only the best-in-class oral KRAS G12D inhibitor, but also the preferred treatment option for patients with KRAS-G12D-mutated cancers," said Michael Kauffman, M.D., Ph.D., president of development at Verastem Oncology. "Importantly, VS-7375 has demonstrated compatibility with both anti-EGFR therapy and standard-of-care chemotherapy, supporting the broad development strategy we are pursuing across pancreatic, non-small cell lung, and colorectal cancers. As patient follow-up matures in the TARGET-D 101 study, we are enrolling patients in our three Phase 2 registration-directed studies. We look forward to sharing additional data on VS-7375 in patients with KRAS G12D-mutated cancers later this year."
Verastem Oncology Updates RAMP 205 Trial Results
Verastem Oncology announced positive updated safety and efficacy results from the RAMP 205 Phase 1b/2a Recommended Phase 2 Dose cohort of 29 patients evaluating avutometinib plus defactinib in combination with gemcitabine and nab-paclitaxel in first-line metastatic pancreatic ductal adenocarcinoma. KRAS is mutated in more than 90% of pancreatic cancers, making it a key driver of tumor growth. The RAMP 205 trial was designed to evaluate whether simultaneous inhibition of KRAS-driven signaling and FAK-mediated resistance pathways, in combination with standard-of-care chemotherapy, could improve outcomes for patients living with metastatic pancreatic cancer.
Verastem Oncology Begins TARGET-D 201 Trial
The company states: "Verastem Oncology announced that the first patient has been dosed in the TARGET-D 201 Phase 2 registration-directed trial evaluating VS-7375, an investigational oral KRAS G12D inhibitor with best-in-class potential, to treat patients with KRAS G12D-mutated metastatic pancreatic ductal carcinoma. TARGET-D 201 is a Phase 2, open-label, multi-center study to evaluate VS-7375 at 900 mg once daily both as monotherapy and in combination with full-dose cetuximab in patients with second-line metastatic pancreatic ductal carcinoma. The study is also evaluating VS-7375 900 mg and cetuximab in the first-line mPDAC setting, representing a potential chemotherapy-free frontline regimen. FDA Fast Track Designation was previously granted for VS-7375 for the treatment of KRAS G12D-mutated advanced or metastatic pancreatic cancer in both the first- and second-line treatment settings. In June 2025, Verastem initiated TARGET-D 101, its Phase 1/2 dose escalation, dose expansion, and combination clinical trial evaluating VS-7375 in patients with advanced KRAS G12D-mutated pancreatic, non-small cell lung, colorectal, and other solid tumor cancers. Enrollment is ongoing with monotherapy dose escalation progressing from 400 mg through 900 mg QD doses without dose-limiting toxicities or major safety concerns observed to date. The study is currently evaluating a 1200 mg QD monotherapy dose and a 900 mg QD dose of VS-7375 in combination with full-dose cetuximab, as well as combinations with either gemcitabine plus nab-paclitaxel or carboplatin/pemetrexed/pembrolizumab."
Verastem Stock Up 11% to $4.00 After FDA Fast Track Designation for VS-7375
Verastem up 11% at $4.00 after announcing FDA Fast Track designation for VS-7375
Verastem Receives FDA Fast Track Designation for VS-7375
The company states: "Verastem announced that the U.S. Food and Drug Administration has granted Fast Track Designation to VS-7375, an oral and potential best-in-class investigational selective KRAS G12D (ON/OFF) inhibitor, for the treatment of adult patients with KRAS G12D-mutated unresectable locally advanced or metastatic non-small cell lung cancer - NSCLC - who have received platinum-based chemotherapy and an anti-PD-(L)1 antibody either concurrently or sequentially. FDA Fast Track Designation was previously granted for VS-7375 for the treatment of KRAS G12D-mutated advanced or metastatic pancreatic cancer. Non-small cell lung cancer (NSCLC) is the most prevalent type of lung cancer, accounting for approximately 80% to 85% of all cases. The majority of patients with NSCLC are diagnosed with advanced-stage disease, either locally advanced (30% to 35%) or metastatic (50% to 55%), which is inoperable. The KRAS G12D mutation occurs in five percent of NSCLC cases and patients with these mutations are known to have reduced responses to standard therapies and poor prognosis. Currently, no therapies are approved by the FDA specifically targeting KRAS G12D mutations in cancer."
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