New Data from Interim Analysis of Verastem Oncology’s RAMP 201 Trial Evaluating Avutometinib and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer to be Presented at the American Society of Clinical Oncology Annual Meeting

Verastem Oncology, (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that an abstract highlighting updated interim results from Part A of the ongoing Phase 2, registration-directed RAMP 201 trial evaluating avutometinib (VS-6766) and defactinib in patients with low-grade serous ovarian cancer (LGSOC) has been selected for a presentation in a Poster Discussion Session at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 2–6, 2023 in Chicago, IL.

The objective of Part A (selection Phase) of the RAMP201 LGSOC study was to determine the go forward regimen between avutometinib monotherapy or the combination of avutometinib and defactinib to be studied in Part B (expansion Phase) of the study. The efficacy and safety of each regimen were assessed in both KRAS mutant and KRAS wild-type recurrent LGSOC. The ongoing expansion Phase of the trial, which is fully enrolled, will evaluate the efficacy and safety of the regimen selected.

“Building on our breakthrough therapy designation, we are pleased with the continued progress of our LGSOC program and look forward to the presentation of these updated results from the RAMP 201 trial at ASCO 2023,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “LGSOC is a difficult disease to treat and one in need of improved therapies to address this unique ovarian cancer. We are working to bring forward what may be the first therapy specifically approved for patients with LGSOC as quickly as possible.”

The Company is in ongoing discussions with the U.S. Food and Drug Administration (FDA) on confirmatory study plans and intends to provide an update after agreement with the FDA. Continued enrollment in the combination arm of RAMP 201 is planned to expand the clinical experience in anticipation of initiation of a confirmatory study.

Details for the ASCO 2023 Annual Meeting presentation are as follows:

Title: Initial efficacy and safety results from ENGOT-ov60/GOG-3052/RAMP 201: A phase 2 study of avutometinib (VS-6766) ± defactinib in recurrent low-grade serous ovarian cancer (LGSOC).
Lead author: Susana Banerjee, Institute of Cancer Research and The Royal Marsden
Abstract #: 5515
Session: Gynecologic Cancer
Poster Session Display Date and Time: 6/5/2023, 1:15 PM-4:15 PM
Poster Discussion Session Date and Time: 6/5/2023, 4:30 PM-6:00 PM
Poster Board Number: 210

About Low-Grade Serous Ovarian Cancer (LGSOC)

Low-grade serous ovarian cancer (LGSOC) is a highly recurrent, chemotherapy-resistant cancer, associated with slow tumor growth and high mortality rate. Approximately 6,000 women in the U.S. and 80,000 worldwide are living with this disease. Mutations in the KRAS gene are present in 30% of cases of LGSOC. LGSOC is most often diagnosed in women between the ages of 45-55 years and has a median survival of approximately ten years. The majority of patients experience severe pain and complications as the disease progresses. Chemotherapy is the standard of care for this disease, with limited treatment options currently available.