Verastem Oncology Initiates Phase 2 Registration-Directed Trial of VS-6766 and Defactinib in Recurrent Low-Grade Serous Ovarian Cancer

Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, today announced the initiation of a Phase 2 registration-directed clinical trial of VS-6766, its RAF/MEK inhibitor, and defactinib, its FAK inhibitor, in patients with recurrent low-grade serous ovarian cancer (LGSOC).

“Results to date have demonstrated the clinical activity of VS-6766 and defactinib in KRAS mutant cancers, signaling potentially promising clinical results in low-grade serous ovarian cancer and in KRAS-G12V mutant non-small cell lung cancer,” said Brian Stuglik, Chief Executive Officer of Verastem Oncology. “The start of our registration-directed trial in recurrent LGSOC is a significant milestone in our work to develop the backbone of therapy for RAS driven tumors, an area of minimal therapeutic results, significant toxicity and limited treatment options.”

The Phase 2 study (GOG3052) is an adaptive two-part multicenter, parallel cohort, randomized, open label trial to evaluate the efficacy and safety of VS-6766 alone and in combination with defactinib in patients with recurrent LGSOC.¹ The first part of the study will determine the optimal regimen of either VS-6766 monotherapy or in combination with defactinib in patients with recurrent LGSOC randomized 1:1 in each treatment arm. The determination of which regimen to take forward into the expansion phase of the trial will be made based on objective response rate data. The expansion phase of the study will examine efficacy and safety parameters of the regimen selected. Trial enrollment is underway in the United States with European sites to follow. Additional information about this study can be found here on ClinicalTrials.gov (NCT04625270). The Company previously announced its successful meeting with the Food and Drug Administration (FDA) in Q3 2020 and the FDA’s support of the Company’s development strategy and adaptive trial design for LGSOC.

According to Susana Banerjee, M.D., Ph.D., Medical Oncologist and Research Lead for the Gynaecology Unit at The Royal Marsden and Team Leader at The Institute of Cancer Research, London, Global and Lead European Investigator of this trial, “Based on my experience treating patients with low-grade serous ovarian cancer in the Phase 1/2 FRAME trial, I have seen firsthand the potential for the combination of VS-6766 and defactinib, particularly in KRAS mutated tumors, which may address the significant limitations we have seen with other therapeutic approaches. This trial will further explore the encouraging response rates, durability and safety profile of VS-6766 and defactinib demonstrated in early phase studies and enable us to evaluate VS-6766 alone and in combination with defactinib to address the unmet needs of women with this specific type of ovarian cancer.”