FDA grants breakthrough therapy designation to combination for recurrent ovarian cancer
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The FDA granted breakthrough therapy designation to VS-6766 with defactinib for treatment of recurrent low-grade serous ovarian cancer, according to the agents’ manufacturer.
The designation applies to use of the combination by women — regardless of KRAS status — who received at least one prior line of therapy, including platinum-based chemotherapy.
VS-6766 (Verastem) is an investigational dual inhibitor of the RAF/MEK pathway. Defactinib (Verastem) is a FAK inhibitor.
The ongoing investigator-initiated phase 1/phase 2 FRAME trial is designed to evaluate the combination for treatment of several cancer types, including among certain patients with non-small cell lung cancer, colorectal cancer and pancreatic cancer.
The most recent results from a cohort of women with recurrent low-grade serous ovarian cancer showed 11 of 21 (52%) response-evaluable patients responded to therapy. Seven of 10 women (70%) with KRAS-mutant disease responded, as did four of nine (44%) with KRAS wild-type disease. Neither of the two evaluable women with undetermined KRAS status responded to treatment.
“Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with current therapies,” Melissa Aucoin, CEO of National Ovarian Cancer Coalition, said in a Verastem-issued press release. “A breakthrough therapy designation in this disease is a significant step forward for the women who often, at a relatively young age, start a lengthy battle with this highly recurrent and impactful disease.”
The most common adverse events observed among study participants included rash, creatine kinase elevation, nausea, hyperbilirubinemia and diarrhea. Most adverse events were grade 1 or grade 2 and all were reversible.
Several women have been on therapy for more than 1 year.
“Breakthrough therapy designation will facilitate our efforts to verify the robust and durable response and compelling safety profile of VS-6766 with defactinib that we have seen in patients with [low-grade serous ovarian cancer] and potentially bring a new therapy to these patients as quickly as possible,” Brian Stuglik, CEO of Verastem Oncology, said in the press release. “The majority of [low-grade serous ovarian cancer] is RAS pathway-driven, and we are committed to exploring the potential for VS-6766 as a backbone therapy across RAS pathway-driven solid tumors.”
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