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 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
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Posted In: BiotechEarningsNewsPenny StocksHealth CareSmall CapFDAGeneralBreakthrough Therapy DrugBriefsFDA Breakthrough DesignationOvarian Cancer
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