Verastem Oncology to Present RAMP 201 Data in Low-Grade Serous Ovarian Cancer at IGCS 2024 Annual Meeting

Verastem Oncology, a biopharmaceutical firm listed on Nasdaq as VSTM, is dedicated to developing novel treatments for cancer patients. Recently, the company announced that a late-breaking abstract presenting mature data from its ongoing Phase 2 RAMP 201 (ENGOT-ov60/GOG-3052) clinical trial will be presented at the International Gynecologic Cancer Society (IGCS) Annual Meeting, scheduled for October 16-18, 2024, in Dublin, Ireland. This presentation will provide updated safety and efficacy data for the combination of avutometinib, a RAF/MEK clamp, and defactinib, a selective FAK inhibitor, in patients with low-grade serous ovarian cancer (LGSOC). Key metrics such as overall response rate, progression-free survival, and duration of response will be highlighted.

Dan Paterson, President and CEO of Verastem Oncology, emphasized the importance of the interim data from the RAMP 201 trial, which has facilitated the commencement of a rolling New Drug Application (NDA) submission to the FDA. He expressed anticipation for the upcoming oral presentation at IGCS and the opportunity to engage with specialists in ovarian cancer. Paterson also noted that the company aims to complete its NDA submission by the fourth quarter of this year.

Avutometinib functions by forming inactive complexes of MEK with ARAF, BRAF, and CRAF, potentially leading to a more comprehensive and lasting anti-tumor response through extensive RAS/MAPK pathway inhibition. Unlike current MEK-only inhibitors, avutometinib not only blocks MEK kinase activity but also prevents RAF from phosphorylating MEK, thereby avoiding the compensatory activation seen with other MEK inhibitors.

Verastem Oncology is actively conducting multiple clinical trials involving avutometinib under its Raf And Mek Program (RAMP). Notably, RAMP 301 is an international Phase 3 confirmatory trial comparing the combination of avutometinib and defactinib with standard chemotherapy or hormonal therapy for recurrent LGSOC. The RAMP 201 trial, a Phase 2 trial aimed at regulatory approval, has completed enrollment.

The company has already initiated a rolling NDA submission to the FDA for the combination of avutometinib and defactinib in adults with recurrent LGSOC. Completion of the NDA submission is anticipated in the latter half of 2024, with a potential FDA decision expected in the first half of 2025. The investigational combination has received Breakthrough Therapy Designation from the FDA for treating recurrent LGSOC after one or more prior therapies, including platinum-based chemotherapy. Additionally, avutometinib, either alone or combined with defactinib, has been granted Orphan Drug Designation by the FDA for treating LGSOC.

Verastem Oncology has also formed clinical collaborations with Amgen and Mirati to evaluate combinations involving LUMAKRAS™ (sotorasib) and KRAZATI™ (adagrasib) in KRAS G12C mutant non-small cell lung cancer (NSCLC). The RAMP 205 trial is exploring avutometinib and defactinib with gemcitabine/nab-paclitaxel in front-line metastatic pancreatic cancer, supported by the PanCAN Therapeutic Accelerator Award. The FDA has granted Orphan Drug Designation for the avutometinib and defactinib combination in the treatment of pancreatic cancer.

Verastem Oncology is a biopharmaceutical company focusing on late-stage development. Their goal is to develop and market new treatments aimed at improving the lives of cancer patients. The company's research pipeline is centered on RAS/MAPK-driven cancers, with a particular emphasis on small molecule drugs that inhibit crucial cancer signaling pathways, including RAF/MEK and FAK inhibition.

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