Press release
Verastem Oncology Outlines Key 2023 Strategic Priorities and Upcoming Catalysts for Advancing Avutometinib as a Backbone of Therapy for RAS Pathway-Driven Cancers
Avutometinib + Defactinib Combination Advancing in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) Based on Positive Data from Planned Interim Analysis of
About this update from Verastem, Inc.
[{"type":"text","content":"\nAvutometinib + Defactinib Combination Advancing in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC) Based on Positive Data from Planned Interim Analysis of Part A of RAMP 201 Trial\n\nInitiation of Confirmatory Study for LGSOC Program Planned in 2023; Timing of Filing for Accelerated Approval Based on RAMP 201 Data Maturity\n\nInitial Data Read-Outs Planned in Other RAS Pathway-Driven Cancers of High Unmet Need\n\nStrengthened Balance Sheet to Deliver on Development Milestones\n\n BOSTON--(BUSINESS WIRE)--\nVerastem Oncology (Nasdaq:VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today outlined key strategic priorities and upcoming catalysts to support its lead compound RAF/MEK clamp avutometinib in RAS pathway-driven cancers.\n\n“Building on the Breakthrough Therapy designation for the combination of avutometinib with defactinib in recurrent LGSOC and the positive results from the interim analysis of Part A of the RAMP 201 trial, we are working rapidly to bring forward the first U.S. Food and Drug Administration (FDA)-approved therapy for these patients who deserve better options,” said Brian Stuglik, CEO of Verastem Oncology. “Further, we plan to efficiently advance our development program and provide early data read-outs with avutometinib combinations across other RAS pathway-driven cancers with high unmet need, including combinations in KRAS G12C mutant NSCLC and frontline metastatic pancreatic cancer. With the recently announced financing, we have strengthened our balance sheet and cash runway to deliver on these key initiatives.”\n\n2022 and Recent Accomplishments\n\n\nCompleted target enrollment in the RAMP 201 trial evaluating avutometinib + defactinib in recurrent LGSOC and reported positive interim data from Part A that included blinded independently confirmed response rates in both KRAS Mutant and KRAS wild-type tumors with a favorable safety and tolerability profile.\n\n\nThe combination of avutometinib and defactinib was selected as the go-forward treatment regimen for the recurrent LGSOC program.\n\n\nIn the KRAS G12C Mutant NSCLC program, the RAMP 203 trial, evaluating the combination of avutometinib with Amgen’s LUMAKRASTM (sotorasib), advanced to final dose level of 4 mg avutometinib with 960 mg of LUMAKRASTM and enrollment was initiated in the RAMP 204 tr...