Dr. Moore discusses the basis for studying the combination of VS-6766 and defactinib in recurrent low-grade serous ovarian cancer, data that has been generated with the combination from the phase 1/2 FRAME trial, and the potential role for the combination in clinical practice.
Welcome to OncLive On Air®! I’m your host today, Jessica Hergert.
OncLive On Air® is a podcast from OncLive®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive® covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.
In today’s episode, sponsored by Verastem Oncology, we had the pleasure of speaking with Kathleen Moore, MD, director of the Oklahoma TSET Phase I Clinical Trials Program; associate director of Clinical Research; medical director of the Clinical Trials Office; associate professor in the Section of Gynecologic Oncology; Jim and Christy Everest Endowed Chair in Cancer Research; and director of the Gynecologic Oncology Fellowship Program at Stephenson Cancer Center, to discuss ongoing research with the combination of VS-6766 and defactinib in ovarian cancer.
The combination of the oral small molecule RAF/MEK inhibitor VS-6766 and the FAK inhibitor defactinib is being evaluated in a phase 2 trial (GOG3052/RAMP201; NCT04625270) in patients with recurrent low-grade serous ovarian cancer (LGSOC).
In the phase 2 trial, investigators will evaluate the safety and efficacy of VS-6766 as a monotherapy and in combination with defactinib in patients with recurrent LGSOC.
Prior data from the phase 1/2 FRAME trial (NCT03875820) showed that VS-6766 plus defactinib induced encouraging response rates, duration of response, and a favorable safety profile in patients with LGSOC.
Updated data from the FRAME trial presented during the 2021 ESMO Congress demonstrated that the combination led to an overall response rate (ORR) of 46% (n = 11); the ORR was 64% (n = 7) in patients with KRAS mutations. Notably, responses were observed in patients who had been previously treated with a MEK inhibitor. Moreover, the median progression-free survival was 23 months (95% CI, 10.6-not reached) in the overall population.
In terms of safety, only 1 patient discontinued treatment for adverse effects with current follow-up.
In May 2021, the FDA granted a breakthrough therapy designation to VS-6766 plus defactinib for the treatment of patients with recurrent LGSOC, irrespective of KRAS status, after 1 or more prior lines of therapy, including platinum-based chemotherapy.
In our exclusive interview, Moore discussed basis for studying the combination of VS-6766 and defactinib in recurrent LGSOC, data that has been generated with the combination from the phase 1/2 FRAME trial, and the potential role for the combination in clinical practice.
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