Verastem Oncology (Nasdaq: VSTM) has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for its investigational RAF/MEK clamp, avutometinib, in combination with Amgen’s KRAS G12C inhibitor, LUMAKRAS™ (sotorasib). This designation aims to expedite the development and review process for the treatment of patients with KRAS G12C-mutant metastatic non-small cell lung cancer (NSCLC), who have received at least one prior systemic therapy and have not previously been treated with a KRAS G12C inhibitor.

Fast Track Designation is designed to accelerate the development of drugs addressing serious conditions and unmet medical needs. Verastem Oncology's goal is to enhance tumor regression by combining avutometinib, which targets the RAS pathway, with LUMAKRAS™.

Dan Paterson, President and CEO of Verastem Oncology, emphasized the importance of this designation and the potential of avutometinib in combination with sotorasib for treating KRAS G12C-mutant NSCLC. Preclinical studies of the combination have shown promising results, including improved tumor regression and reduced tumor relapse frequency compared to sotorasib alone.

The ongoing RAMP 203 clinical development program, assessing avutometinib + sotorasib in KRAS G12C-mutant NSCLC patients, has demonstrated confirmed responses in both inhibitor-resistant and inhibitor-naïve patients. The Recommended Phase 2 Dose (RP2D) was determined based on dose-limiting toxicity assessment.

Avutometinib's distinct mechanism, blocking both MEK kinase activity and RAF's ability to phosphorylate MEK, sets it apart from existing MEK inhibitors. Verastem Oncology has additional trials underway, exploring avutometinib in RAS pathway-driven tumors, and collaborating with Amgen and Mirati in combination trials.

Breakthrough Therapy designation has also been granted for avutometinib with defactinib, the company's FAK inhibitor, for treating patients with recurrent low-grade serous ovarian cancer. Clinical trials, including RAMP 201 and RAMP 205, are evaluating avutometinib's potential across various cancer indications, highlighting its role in advancing cancer treatment options.

 

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