Verastem Oncology Provides Update on RAMP 203 Phase 1/2 Clinical Trial for Advanced KRAS G12C Mutant Non-Small Cell Lung Cancer

Excerpt from the Press Release:

BOSTON–(BUSINESS WIRE)–Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with RAS/MAPK pathway-driven cancers, today announced that following evaluation of interim data from the RAMP 203 clinical trial in advanced KRAS G12C-mutated non-small cell lung cancer (NSCLC) it will discontinue the trial to focus resources on clinical development of VS-7375, an oral KRAS G12D (ON/OFF) inhibitor, in advanced NSCLC and other solid tumors. There will be no further enrollment and patients currently enrolled will have the option to continue treatment per investigator discretion. This decision reflects the evolving treatment landscape for KRAS G12C inhibitors and the strategic prioritization of programs with the greatest potential impact for patients living with advanced lung cancer.

“RAMP 203 has provided important insights into treatment strategies and demonstrated proof-of-concept. While avutometinib plus defactinib combined well with a G12C inhibitor to drive early and sustained anti-tumor responses, next generation G12C inhibitors are establishing a new benchmark with higher response rates. Accordingly, we are prioritizing our clinical development of VS-7375, a potentially best-in-class oral KRAS G12D (ON/OFF) inhibitor, that demonstrated a 69% response rate (11 of 16, both confirmed and unconfirmed) in advanced KRAS G12D NSCLC and has the potential to help more patients with its differentiated approach in multiple solid tumors; and the RAMP 205 clinical trial evaluating avutometinib plus defactinib in combination with chemotherapy in first line metastatic pancreatic cancer,” said John Hayslip, chief medical officer at Verastem Oncology. “We sincerely appreciate and thank the investigators, patients, and families who participated in this program as these clinical outcomes will contribute to the development of novel therapies urgently needed for this challenging cancer.”

RAMP 203 is a Phase 1/2 clinical trial being conducted in collaboration with Amgen evaluating avutometinib, an oral RAF/MEK clamp, and LUMAKRAS™ (sotorasib) in a “doublet combination” and also with defactinib, an oral FAK inhibitor, as a “triplet combination” in patients naïve to or previously treated with a KRAS G12C inhibitor.

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