Press release
Verastem Oncology Outlines Key 2024 Strategic Priorities and Upcoming Catalysts for Advancing Avutometinib and Defactinib and Broader Pipeline in RAS Pathway-Driven Cancers
Expect to Begin Rolling Submission of New Drug Application (NDA) for Accelerated Approval to FDA for Avutometinib and Defactinib Regimen in Recurrent
About this update from Verastem, Inc.
[{"type":"text","content":"\nExpect to Begin Rolling Submission of New Drug Application (NDA) for Accelerated Approval to FDA for Avutometinib and Defactinib Regimen in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) in H1 2024; Prepare for Potential Commercial Launch in 2025\n\n\nInitial Data Read-Out from RAMP 205 Trial of Avutometinib and Defactinib Combination Plus Standard of Care Chemotherapy in Frontline Metastatic Pancreatic Cancer Planned for H1 2024\n\n\nData from RAMP 203 and RAMP 204 Trials in KRAS G12C-Mutant Non-Small Cell Lung Cancer (NSCLC) Planned for Mid-2024\n\n\n BOSTON--(BUSINESS WIRE)--\nVerastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today outlined key 2024 strategic priorities and upcoming catalysts to support advancement of its clinical programs in RAS pathway-driven cancers.\n\n\n“We have made significant progress in our commitment to advancing new solutions for RAS pathway-driven cancers and look forward to an exciting and catalyst-filled year ahead. With plans to submit an NDA for Accelerated Approval for the combination of avutometinib and defactinib in recurrent low-grade serous ovarian cancer in the first half of this year, we are working rapidly to bring forward the first potential therapy approved by the U.S. Food and Drug Administration for patients with LGSOC in need of better treatment options,” said Dan Paterson, President and Chief Executive Officer of Verastem Oncology. “Further, we plan to provide data read-outs with avutometinib and defactinib combinations in KRAS G12C-mutant non-small cell lung cancer and frontline metastatic pancreatic cancer, as well as supporting our collaborator GenFleet in advancing oral KRAS G12D inhibitor GFH375/VS-7375 into a Phase 1 clinical trial this year.”\n\n\n2023 and Recent Accomplishments\n\n\n\nPresented interim results from the Phase 1/2 RAMP 201 trial of avutometinib and defactinib in LGSOC, including an objective response rate (ORR) of 45% (13/29) and disease control in 86% (25/29) of evaluable patients. Safety and tolerability continued to be favorable and consistent with previously reported data.\n\n\n\nFinalized design with the FDA and initiated confirmatory Phase 3 RAMP 301 trial to evaluate the efficacy and safety of avutometinib and defactinib versus standard chemotherapy or hormonal therapy for...