Press Release

Revolution Medicines to Present Interim Data at ENA 2020 from Phase 1b/2 Clinical Trial Combining RMC-4630 with Cobimetinib for RAS-Addicted Solid Tumors

October 12, 2020

Study Findings Selected for Oral Presentation in Plenary Session at EORTC-NCI-AACR 32nd Symposium on Molecular Targets and Cancer Therapeutics

REDWOOD CITY, Calif., Oct. 12, 2020 (GLOBE NEWSWIRE) -- 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®).  

About RMC-4630

RMC-4630 is currently being evaluated in a Phase 1 monotherapy clinical trial (RMC-4630-01) for a range of tumor types featuring specific, molecularly-defined oncogenic mutations, a Phase 1b/2 trial (RMC-4630-02) in combination with cobimetinib in patients with relapsed/refractory solid tumors displaying specific genomic mutations, a Phase 1b study (CodeBreaK 101) in combination with AMG 510 in patients with advanced solid tumors harboring the KRASG12C mutation, and a Phase 1 study in combination with pembrozilumab in patients with advanced malignancies.

The SHP2 inhibitor program, including RMC-4630, is the focus of an exclusive global research, development and commercialization agreement with Sanofi.

About Revolution Medicines, Inc.

Revolution Medicines is a clinical-stage precision oncology company developing novel targeted therapies to inhibit high-value frontier targets in RAS-addicted cancers. The company possesses sophisticated structure-based drug discovery capabilities built upon deep chemical biology and cancer pharmacology know-how and innovative, proprietary technologies that enable the creation of small molecules tailored to unconventional binding sites.

The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress various oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. RAS(ON) Inhibitors include compounds targeting KRASG12C(ON), KRASG12D(ON) and other RAS variants. RAS Companion Inhibitors include RMC-4630 targeting SHP2, RMC-5552 targeting mTORC1, and inhibitors of SOS1.

Cotellic® is the registered trademark of Genentech, Inc. (a member of the Roche Group).

Forward Looking Statements

This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this press release that are not historical facts may be considered "forward-looking statements," including without limitation statements regarding the ongoing RMC-4630-02 trial, the ability of drug combinations to defeat drug resistance mechanisms exploited by RAS-addicted cancers, the utility of RMC-4630 as a backbone for combination treatments, and the potential benefits of, and markets for, Revolution Medicines’ potential product candidates. Forward-looking statements are typically, but not always, identified by the use of words such as "may," "will," "would," "believe," "intend," "plan," "anticipate," "estimate," "expect," and other similar terminology indicating future results. Such forward-looking statements are subject to substantial risks and uncertainties that could cause our development programs, future results, performance or achievements to differ materially from those anticipated in the forward-looking statements. Such risks and uncertainties include without limitation risks and uncertainties inherent in the drug development process, including Revolution Medicines’ programs’ early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, Revolution Medicines’ ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of Revolution Medicines’ capital resources to fund operations, reliance on third parties for manufacturing and development efforts, changes in the competitive landscape and the effects on our business of the worldwide COVID-19 pandemic. For a further description of the risks and uncertainties that could cause actual results to differ from those anticipated in these forward-looking statements, as well as risks relating to the business of Revolution Medicines in general, see Revolution Medicines’ Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 10, 2020, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, Revolution Medicines undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.

Contacts: For Investors: Vida Strategic Partners Stephanie Diaz 415-675-7401 For Media: Vida Strategic Partners Tim Brons 415-675-7402