Verastem Oncology Announces Initial Results of RAMP 203 Trial of Avutometinib and LUMAKRAS™ (sotorasib) in KRAS G12C-Mutant Non-Small Cell Lung Cancer

Verastem Oncology, a biopharmaceutical company dedicated to developing innovative cancer treatments, has announced promising preliminary results from the RAMP 203 trial. The trial evaluated the combination of avutometinib and sotorasib in patients with KRAS G12C-mutant non-small cell lung cancer (NSCLC), including those who were resistant to KRAS G12C inhibitors and those who were treatment-naïve.

The study demonstrated preliminary efficacy with confirmed responses in both KRAS G12C inhibitor resistant and naïve patients. The confirmed objective response rate (ORR) was 25% across efficacy-evaluable patients, with responses observed in 14.3% of KRAS G12C inhibitor resistant patients and 40% of naïve patients.

Importantly, no new safety signals were observed in the combination therapy, and most treatment-related adverse events were mild to moderate. This suggests that the avutometinib and sotorasib combination is well-tolerated and has a favorable safety profile.

The RAMP 203 trial aims to investigate the potential benefits of a more complete vertical blockade of the RAS pathway by combining avutometinib and sotorasib. The initial findings, including the recommended Phase 2 dose and the encouraging preliminary efficacy and safety results, provide support for the combination therapy.

Dr. Mark Awad, an investigator on the trial, expressed optimism about the results, stating, “These initial findings… provide support for the combination, and I look forward to completing the expansion phase of the trial.” The expansion phase of the trial is currently enrolling patients who are either naïve to or previously treated with a KRAS G12C inhibitor.

Verastem Oncology’s avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF, and CRAF, potentially leading to a more complete and durable anti-tumor response. The combination of avutometinib and sotorasib aims to enhance the depth of MAPK pathway inhibition and improve tumor regression.

The company is also conducting other clinical trials with avutometinib, including RAMP 301, a Phase 3 confirmatory trial evaluating the combination of avutometinib and defactinib for the treatment of recurrent low-grade serous ovarian cancer (LGSOC). Verastem Oncology has established clinical collaborations with Amgen and Mirati to evaluate avutometinib in combination with LUMAKRAS™ (sotorasib) and KRAZATI™ (adagrasib) in KRAS G12C mutant-NSCLC.

Verastem Oncology is committed to developing and commercializing new medicines to improve the lives of cancer patients. Their pipeline focuses on novel small molecule drugs that inhibit critical signaling pathways in cancer, including RAF/MEK inhibition and focal adhesion kinase (FAK) inhibition.

The positive preliminary results from the RAMP 203 trial are a significant step forward in the development of effective treatments for KRAS G12C-mutant NSCLC. With ongoing research and clinical trials, Verastem Oncology is dedicated to advancing new treatment approaches and providing hope for patients with cancer.