Item 7.01 Regulation FD Disclosure.
After consultation with Amgen Inc., Revolution Medicines, Inc. (the “Company”) is providing an update to investors regarding the Amgen-sponsored Phase 1b study of RMC-4630 in combination with Amgen’s KRASG12C(OFF) inhibitor, AMG 510 or sotorasib, as part of Amgen’s CodeBreak 101 study. This arm will be referred as CodeBreak 101c study hereafter.
To date, the available data from the RMC-4630 and sotorasib combination in this ongoing study has demonstrated acceptable tolerability and cleared early dose levels. Amgen’s CodeBreaK 101c study is currently dosing patients at the RMC-4630 target dose of 200 mg on a Day 1/Day 2 weekly schedule (i.e., the full dose used by the Company in monotherapy). The Company looks forward to selection of a combination dose in the second half of 2021.
The Company does not currently expect clinical data from the RMC-4630 and sotorasib combination to be provided in 2021. The Company expects Amgen, as sponsor of this study, to report data from CodeBreaK 101c at a future date to be determined at Amgen’s discretion and in accordance with their customary practices.
The information in Item 7.01 of this Current Report on Form 8-K shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that section, nor shall it be, or be deemed, incorporated by reference in any filings under the Securities Act of 1933, as amended, except as expressly set forth by specific reference in such a filing, regardless of any general incorporation language in any such filing, unless the Company expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.
This report contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this report that are not historical facts may be considered “forward-looking statements,” including without limitation statements regarding the expected timing of selection of a RMC-4630 and sotorasib combination dose in Amgen’s CodeBreak 101c study in the second half of 2021. 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 the company’s 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, the company’s ability to successfully establish, protect and defend its intellectual property, other matters that could affect the sufficiency of the company’s 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 the Company in general, see the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 2, 2021, and its future periodic reports to be filed with the Securities and Exchange Commission. Except as required by law, the Company undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances, or to reflect the occurrence of unanticipated events.
