Verastem Oncology Outlines Key 2024 Strategic Priorities and Upcoming Catalysts for Advancing Avutometinib and Defactinib and Broader Pipeline in RAS Pathway-Driven Cancers - Seite 2

LGSOC Program

• Begin submission of an NDA to the FDA for Accelerated Approval for the combination of avutometinib and defactinib in recurrent LGSOC in H1 2024; prepare for potential commercial launch in 2025.
• Present full data from Part A and Part B of RAMP 201 trial in LGSOC at a scientific medical conference in H1 2024.
• Initiate discussions with European and Japanese regulatory authorities for the avutometinib and defactinib regimen in LGSOC to address patient needs outside the U.S.

KRAS G12C-Mutant NSCLC Program

• Based on stronger tumor regressions in KRAS G12C-mutant NSCLC preclinical models when FAKi is added along with G12Ci + avutometinib, add defactinib to the RAMP 203 trial of avutometinib with sotorasib.
• Data updates from RAMP 203 and RAMP 204 trials planned for mid-2024.

Frontline Metastatic Pancreatic Cancer Program

• Present initial safety and efficacy results from RAMP 205 trial of avutometinib and defactinib in combination with standard of care gemcitabine and nab-paclitaxel in frontline metastatic pancreatic cancer in H1 2024.

GenFleet Collaboration

• GenFleet expected to submit an IND for GFH375/VS-7375 in China for patient with KRAS G12D mutations in H1 2024 and begin a Phase 1 trial for GFH375/VS-7375 in China in H2 2024.
• Companies to continue discovery/lead optimization for second and third programs.

About the Avutometinib and Defactinib Combination

Avutometinib is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. In contrast to currently available MEK inhibitors, avutometinib blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows avutometinib to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK clamp avutometinib, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent LGSOC regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.