Press release
Verastem Oncology Reports Fourth Quarter and Full Year 2022 Financial Results and Highlights Recent Company Progress
Positive Interim Data Read-Out of RAMP 201 and Productive FDA Meeting Support Avutometinib + Defactinib Combination in Recurrent Low-Grade Serous Ovarian
About this update from Verastem, Inc.
[{"type":"text","content":"\nPositive Interim Data Read-Out of RAMP 201 and Productive FDA Meeting Support Avutometinib + Defactinib Combination in Recurrent Low-Grade Serous Ovarian Cancer (LGSOC)\n\nStudies of Avutometinib Combinations in Other RAS Pathway-Driven Cancers Advancing\n\nCompany Cash, Cash Equivalents, and Investments of $87.9 Million as of December 31, 2022; Pro-Forma $117.9 Million Including the Sale of Series B Convertible Preferred Stock\n\n BOSTON--(BUSINESS WIRE)--\nVerastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today reported financial results for the three months and full year ended December 31, 2022, and highlighted recent progress.\n\n“Building on our breakthrough therapy designation, we have made significant progress advancing our LGSOC program, including selecting the combination of avutometinib and defactinib as the go-forward treatment regimen in recurrent disease regardless of KRAS mutation with the goal of filing for accelerated approval upon data maturity in the RAMP 201 trial and initiation of a confirmatory study,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “We believe we are well-positioned to bring this potential new combination therapy to patients who have been waiting for the first U.S. Food and Drug Administration (FDA) approved medicine for this disease. Our debt facility and recent private placement offering add flexibility to our financial strength and are expected to support the continued development of avutometinib in combinations across RAS pathway-driven cancers of high unmet need.”\n\nFourth Quarter 2022 and Recent Highlights\n\nLow Grade Serous Ovarian Cancer (LGSOC)\n\n\nThe Company held a productive meeting with the FDA to discuss the encouraging results to date of the ongoing RAMP 201 LGSOC trial evaluating avutometinib ± defactinib among patients with recurrent LGSOC, confirmed the go forward treatment regimen selection of avutometinib and defactinib based on a planned interim analysis with prespecified criteria and discussed the regulatory path forward.\n\n\nOf the 29 patients evaluable for response by blinded independent central review (BICR) in the combination arm, the initial results showed a confirmed objective response rate (ORR) of 28% in all patients and 27% vs 29% in KRAS mutant (n=15) and KRAS w...