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.
As of November 26, 2025, the data cutoff, 66 patients were treated at the recommended Phase 2 dose (RP2D), had at least one tumor scan, and were evaluable for efficacy.
- For the doublet combination, 30 G12C-inhibitor treatment-naïve patients were efficacy evaluable and achieved an overall response rate (ORR) of 40% (12/30) and the median progression-free survival (mPFS) was 11.1 months with a median follow up of 15.9 months.
- In the previously G12C-inhibitor treated group for the doublet combination, 21 patients were efficacy evaluable and achieved an ORR of 9.5% (2/21) and a mPFS of 3.7 months with a median follow up time of 10.8 months.
- Among six G12C-inhibitor treatment-naïve patients in the triple combination, four were evaluable for efficacy and achieved an ORR of 50% (2/4); one confirmed and one unconfirmed, and one additional patient had a best response of stable disease (SD).
- Among 12 patients on the triplet combination who were previously treated with a KRAS G12C inhibitor, 11 were efficacy evaluable and four (36%) showed greater than 30% tumor reduction with seven still ongoing as of the data cutoff.
- Median PFS could not be determined in the triplet treatment-naïve combination cohort, whereas those previously treated with a G12C inhibitor in the triplet combination showed a median PFS of 3.6 months.
- Across the doublet and triplet combinations evaluated, no dose-limiting toxicities were observed. Treatment related adverse events were generally manageable, with nausea (56.8%), diarrhea (52.7%), and fatigue (45.9%) the most common.
The Company is assessing opportunities to share the data in the future.
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