Verastem announces initial results of RAMP 203 trial of avutometinib, LUMAKRAS

Verastem Oncology announced the initial safety, pharmacokinetics and recommended Phase 2 dose in the RAMP 203 trial evaluating the safety, tolerability and efficacy of avutometinib in combination with sotorasib in patients with KRAS G12C-mutant non-small cell lung cancer. The results were presented at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics October 11-15, 2023 in Boston, Massachusetts. RAMP 203 is a Phase 1/2, multicenter, open label, dose evaluation/expansion study evaluating the efficacy and safety of avutometinib + sotorasib in patients with KRAS G12C-mutant NSCLC who have not been previously treated with a KRAS G12C inhibitor as well as in patients who have been previously treated with a KRAS G12C inhibitor. The confirmed objective response rate was 25% across efficacy-evaluable patients and seen in both KRAS G12C inhibitor resistant and naive patients. The pharmacokinetic profile of avutometinib in combination with sotorasib was similar to results in monotherapy studies. No drug-drug interactions were observed between avutometinib and sotorasib. Avutometinib 4.0 mg PO BIW 21/28 days + sotorasib 960 mg PO QD 28/28 days was selected as RP2D based on dose limiting toxicity assessment. Enrollment of patients with KRAS G12C-mutant NSCLC who are either naive to or previously treated with a KRAS G12C inhibitor is ongoing in the expansion phase of RAMP 203.