Verastem...announced that the U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of its investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy. The combination of VS-6766 with defactinib is being evaluated in the ongoing investigator-initiated Phase 1/2 FRAME trial. In the most recent read-out from the FRAME LGSOC cohort (n=24), the overall response rate (ORR) is 52% (11 of 21 response evaluable patients), with KRAS mutant ORR at 70% (7 of 10 response evaluable patients), KRAS wild-type ORR at 44% (4 of 9 response evaluable patients)...

...- In Part A KRAS mutation, KRAS wt...

The interim data support avutometinib + defactinib as an active go-forward regimen in heavily-pretreated recurrent LGSOC, regardless of KRAS status. No new safety signals were observed, and most AEs were mild to moderate.