I was recently at the AWCR and ECOG-ACRIN oncology meetings and the reports on the phase II trial were very favorable. The RASolute 302 trial is underway in multiple sites including international sites and this drug is expected to receive expedited review when the study is complete for approval.

The management of RAS-related side effects with RMC-6236 appears to mirror the approach used for patients treated with EGFR inhibitors for metastatic colorectal cancer. This involves
antibiotic started as a preventive measure, typically cycling twice a day.

To address risk, topical steroids
and topical antibiotics are being used. Additionally, the study data indicates that dose modifications (interruptions or reductions) were used to manage side effects in some patients. Rash was the most common reason for dose reduction. Importantly, very few patients discontinued treatment due to Treatment Related Adverse Events (TRAEs) in the Phase 1 study.

Implications for Phase III:

It's likely that the experience from the Phase 1 trial, including the observed side effects and successful management strategies, will inform how side effects are monitored and managed in the ongoing Phase III RASolute 302 trial. The focus will likely remain on proactive management of common side effects like rash and gastrointestinal issues using similar supportive measures and dose adjustments as needed.