Benzinga | May 24, 2021 12:03PM EDT

Verastem's VS-6766/Defactinib Combo Gets Breakthrough Therapy Tag For Ovarian Cancer; BTIG Upgrades Stock

* The FDA has granted Breakthrough Therapy designation to Verastem Inc (NASDAQ: VSTM) for the combination of its investigational VS-6766, with defactinib, for 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 is being evaluated in the 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%, with KRAS mutant ORR at 70%, KRAS wild-type ORR 44%, and KRAS status undetermined ORR at 0%.

* The most common side effects seen in the study were mild or moderate rash, creatine kinase elevation, nausea, hyperbilirubinemia, and diarrhea.

* Breakthrough Therapy designation allows for the expedited development and review of drugs.

* BTIG has upgraded VSTM to Buy with an $8 price target.

* Price Action: VSTM shares are up 16.8% at $3.73 on the last check Monday.

* Related content: Benzinga's Full FDA Calendar