Revolution Medicines, Inc. (NASDAQ:RVMD), a clinical-stage precision oncology company developing targeted therapies to inhibit frontier targets in RAS-addicted cancers, today announced that interim data from the company’s ongoing Phase 1b/2 clinical trial (RMC-4630-02) evaluating the combination of RMC-4630 and cobimetinib (Cotellic®) will be reported in an oral presentation in a plenary session at the upcoming EORTC-NCI-AACR 32nd Symposium on Molecular Targets and Cancer Therapeutics (ENA 2020) being held virtually October 24-25, 2020.
The ongoing Phase 1b/2 RMC-4630-02 trial is an open-label, dose-escalation and dose-expansion study designed to evaluate the safety, tolerability, pharmacokinetic, and pharmacodynamic proﬁles of RMC-4630 and cobimetinib in adult patients with relapsed/refractory solid tumors that harbor specific genomic mutations. The study tested several dosing regimens, including intermittent RMC-4630 plus daily or intermittent cobimetinib. Preliminary data to be presented at ENA 2020 will focus on safety, tolerability and pharmacokinetic findings from combination dosing regimens.
“We are gratified that data from our ongoing combination trial of RMC-4630 and cobimetinib were selected for presentation at ENA 2020. Drug combinations will likely be critical to defeating inherent drug resistance mechanisms exploited by RAS-addicted cancers,” said Steve Kelsey, M.D., president of research and development at Revolution Medicines. “We remain keenly focused on testing the clinical hypothesis that RMC-4630 may be useful as a backbone for various combination treatments designed for different cancers with distinct molecular profiles.”
Details of the upcoming oral presentation at ENA 2020 are as follows:
- Title: Intermittent dosing of RMC-4630, a potent, selective inhibitor of SHP2, combined with the MEK inhibitor cobimetinib, in a Phase 1b/2 clinical trial for advanced solid tumors with activating mutations of RAS signaling
- Session: Plenary Session 1: Late-Breaking and Best Proffered Papers
- Presenting Author: Johanna C. Bendell, M.D., Sarah Cannon Research Institute, Nashville, Tennessee
- Presentation Date/Time: Saturday, October 24, 2020, 3:45 – 3:55 p.m. CEST (9:45 – 9:55 a.m. Eastern/6:45 – 6:55 a.m. Pacific)
- Live Virtual Q&A: To follow completion of Plenary Session 1 presentations
RMC-4630 and cobimetinib are targeted inhibitors of oncogenic proteins at distinct positions within the RAS signaling cascade that is frequently exploited by human cancers and may develop adaptive resistance to single agent treatment. RMC-4630 is a potent and orally bioavailable small molecule designed to selectively inhibit the activity of SHP2, an upstream cellular protein that plays a key role in modulating cell growth by transmitting signals from receptor tyrosine kinases to RAS. Cobimetinib, marketed in the U.S. by Genentech, a member of the Roche group, inhibits the activity of MEK, a downstream effector of RAS that affects cell survival and growth. Cobimetinib is approved in the U.S. for the treatment of patients with BRAFV600E or BRAFV600K mutation-positive unresectable or metastatic melanoma in combination with vemurafenib (Zelboraf®).