On July 27, 2021 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported that an abstract detailing updated results from the ongoing Phase 1/2 FRAME study investigating VS-6766, the Company’s RAF/MEK inhibitor, in combination with defactinib, its FAK inhibitor, in patients with low grade serous ovarian cancer (LGSOC) has been selected for a mini oral presentation at the upcoming European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021, taking place virtually September 16-21, 2021 (Press release, Verastem, JUL 27, 2021, View Source [SID1234585238]).
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"The investigator-sponsored FRAME study has been instrumental in providing the foundational knowledge regarding the safety, efficacy and durability of the VS-6766/defactinib combination as well as the basis for the breakthrough therapy designation recently granted by the FDA. We are pleased this abstract has been selected for a mini oral presentation at ESMO (Free ESMO Whitepaper) 2021, and we look forward to further engaging with the medical community regarding these important data," said Jonathan Pachter, Ph.D., Chief Scientific Officer of Verastem Oncology. "Patients with low-grade serous ovarian cancer urgently need better solutions due to low response rates and tolerability issues associated with other therapeutic approaches. The company-sponsored, registration-directed Phase 2 RAMP 201 study is well underway, with top-line results from the selection phase expected during the first half of 2022."
Verastem Oncology is currently evaluating the efficacy and safety of VS-6766 alone and in combination with defactinib in the registration-directed Phase 2 RAMP 201 (Raf And Mek Program) (ENGOTov60/GOG3052) trial in patients with recurrent LGSOC.1
Details for the ESMO (Free ESMO Whitepaper) 2021 mini oral presentation are as follows:
Title: Phase I study of the combination of the dual RAF/MEK inhibitor VS-6766 and the FAK inhibitor defactinib: Results of efficacy in low grade serous ovarian cancer
Speaker: Susana Banerjee, Royal Marsden NHS Foundation Trust
Presentation #: 725MO
Session: Mini oral – Gynaecological cancers
Date and Time: Sunday, September 19, 2021; 17:50-17:55 CEST
About the VS-6766/Defactinib Combination
The combination of VS-6766 and defactinib has been found to be clinically active in patients with KRAS mutant tumors. In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with LGSOC, KRAS mutant NSCLC and colorectal cancer (CRC). The FRAME study was expanded to include new cohorts in pancreatic cancer, KRAS mutant endometrioid cancer and KRAS-G12V NSCLC. Verastem Oncology is also supporting an investigator-initiated Phase 2 trial evaluating VS-6766 with defactinib in patients with metastatic uveal melanoma. Verastem Oncology has initiated Phase 2 registration-directed trials of VS-6766 with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS-G12V mutant NSCLC as part of its RAMP (Raf And Mek Program).
The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.