Verastem Oncology (NASDAQ:VSTM) has announced the commencement of phase 2 registration-focused clinical study of its RAF/MEK inhibitor, VS-6766, and its FAK inhibitor, defactinib, in treating recurrent low-grade serous ovarian cancer patients.
Results demonstrated clinical activity o VS-6766 and defactinib
Brian Stuglik, Verastem Oncology’s CEO, stated that the result has so far shown clinical activity of defactinib and VS-6766 in KRAS mutant cancers. This signals potentially encouraging clinical results in LGSOC and KRAS-G12V mutant NSCLC. He added that the commencement of the registration-directed study in recurrent LGSOC is a massive milestone in the company’s work to create the base for RAS driven tumors therapy. Brian said that this area would limited therapeutic results, limited treatment alternatives, and significant toxicity.
The second phase GIG3052 trial is an adaptive, parallel cohort, two-part multicentre, open-label, and a randomized study evaluating the safety and efficacy of VS-6766 alone and with defactinib in LGSIC patients. The first part of the trial will be determining the optimal regime of VS-6766 monotherapy or in combination with defactinib in recurrent LGSOC patients randomized 1:1 in both arms. The company seeks to determine the optimal regiment to advance to the study’s expansion phase, depending on objective response rate results.
VS-6766 in combination with defactinib has potential in KRAS mutations
Recently the company announced that it held a successful meeting with the FDA in Q3 2020. The FDA offered support for the development strategy of the company and LGSOC’s adaptive trial design.
European lead trial investigator Susana Banerjee said that based on LGSOC patient experiences in the Phase 1/2 FRAME study, there is the potential of the VS-6766 and defactinib combination in KRAS mutation working. This could address some limitations experienced with current therapeutic approaches. She added that the trial would explore the encouraging response rates, safety profile, and durability demonstrated by VS-6766 and defactinib in early phase studies, thus allowing VS-6766 evaluation as a monotherapy or in combination with defactinib to address unmet needs of patients with LGSOC.