Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage
oncology company developing targeted therapies for RAS-addicted
cancers, today announced promising anti-tumor and safety data for
RMC-6236, its RASMULTI(ON) Inhibitor, in patients with previously
treated non-small cell lung cancer (NSCLC) and pancreatic ductal
adenocarcinoma (PDAC) across several dose levels and KRASG12X
genotypes, including common KRAS-mutant genotypes G12D and G12V.
These initial results were presented during a Proffered Paper
session at the European Society for Medical Oncology (ESMO)
Congress in Madrid, October 20-24, 2023.
“Today’s presentation marks an important milestone in the
clinical development of RMC-6236, an unprecedented, oral
RASMULTI(ON) Inhibitor with an innovative mechanism of action. The
findings reinforce our belief that by inhibiting the (ON), or
active, form of diverse RAS cancer drivers, RMC-6236 can lead to
meaningful clinical responses in patients at dose levels that are
generally well tolerated,” said Mark A. Goldsmith, M.D., Ph.D.,
chief executive officer and chairman of Revolution Medicines.
“These data also confirm that RMC-6236 can target multiple common
RAS variants that cause cancer, supporting its ongoing development
as monotherapy in patients with NSCLC or PDAC harboring RAS
mutations. Further, RMC-6236 has a compelling profile for
evaluation in combination treatment strategies with RMC-6291, our
mutant-selective RASG12C(ON) Inhibitor, and with immunotherapy and
other cancer drugs.”
The RMC-6236-001 Phase 1/1b trial is a multicenter, open-label,
dose-escalation and dose-expansion study designed to evaluate
RMC-6236 as monotherapy in patients with advanced solid tumors
harboring KRASG12X mutations. As of an October 12, 2023 data
extraction, a total of 111 patients with NSCLC (n=46) or PDAC
(n=65) were treated at dose levels administered once daily (QD)
ranging from 80 mg to 400 mg. Common KRAS mutations in patients
evaluated included G12D, G12V, G12R, G12A and G12S; patients with
KRASG12C mutations were excluded from the study due to the
availability of currently approved KRASG12C(OFF) inhibitors. All
patients had previously been treated with standard of care
appropriate for tumor type and stage. Patients with NSCLC had
received a median of two prior lines of therapy (range 1–6) while
patients with PDAC had received a median of three prior lines of
therapy (range 1–7).
RMC-6236 demonstrated preliminary evidence of clinical activity
and an acceptable safety profile that was generally well tolerated
across the dose levels analyzed. Clinical activity was evaluated in
patients who had received the first dose of RMC-6236 at least eight
weeks prior to the data extraction date (n=86). Among the 40
efficacy evaluable NSCLC patients, the objective response rate was
38 percent, with one patient achieving a complete response (CR) as
a best response and 14 patients achieving a partial response (PR)
(including three unconfirmed PRs). The disease control rate (DCR)
in this NSCLC population was 85 percent. Among the 46 efficacy
evaluable PDAC patients, the objective response rate was 20
percent, with nine patients achieving a PR (including four
unconfirmed PRs) as a best response. The DCR in this PDAC
population was 87 percent. Confirmed objective responses included
tumors harboring KRAS mutations G12D, G12V or G12R, and disease
control was observed across all KRAS mutations, including G12A and
G12S.
The most common treatment-related adverse events (TRAEs) were
rash and GI-related toxicities that were primarily Grade 1 or 2 in
severity. The reported Grade 3 TRAEs were rash (6%), stomatitis
(2%), and diarrhea (1%). One previously reported Grade 4 TRAE
occurred in a patient with PDAC at the 80 mg QD dose level who had
a large intestine perforation at the site of an invasive tumor that
reduced in size while on treatment, which resulted in treatment
discontinuation. No safety signals were observed that indicated an
elevated risk of hepatotoxicity, which has been reported for some
KRASG12C(OFF) inhibitors.
“There is a high unmet need among patients living with
KRAS-mutated NSCLC or PDAC, two aggressive cancer types for which
current standard of care treatments are often inadequate,” said
Kathryn C. Arbour, M.D., thoracic oncologist at Memorial Sloan
Kettering Cancer Center and a principal investigator for the
RMC-6236-001 study. “It is quite encouraging to see this level of
anti-tumor activity in previously treated patients by a generally
well-tolerated investigational drug. We look forward to continuing
the dose optimization portion of the Phase 1/1b study to inform
future development and further our understanding of the effects of
RMC-6236 on RAS-mutant cancers.”
Investor WebcastRevolution Medicines will host
an investor webcast on Sunday, October 22, 2023 at 12:30 p.m.
Eastern Time to discuss the data presented at both the 2023
AACR-NCI-EORTC Triple meeting and ESMO, in addition to other
pipeline updates. To participate in the live webcast, participants
may register in advance here:
https://edge.media-server.com/mmc/p/eb8agxe6. A live webcast of the
call will also be available on the Investors section of Revolution
Medicines’ website at
https://ir.revmed.com/events-and-presentations. Following the live
webcast, a replay will be available on the company’s website for at
least 14 days.
About Revolution Medicines, Inc.Revolution
Medicines is a clinical-stage oncology company developing novel
targeted therapies for RAS-addicted cancers. The company’s R&D
pipeline comprises RAS(ON) Inhibitors designed to suppress diverse
oncogenic variants of RAS proteins, and RAS Companion Inhibitors
for use in combination treatment strategies. The company’s RAS(ON)
Inhibitors RMC-6236 (RASMULTI), RMC-6291 (KRASG12C) and RMC-9805
(KRASG12D) are currently in clinical development. Additional
RAS(ON) Inhibitors in the company’s pipeline include RMC-0708
(KRASQ61H) and RMC-5127 (KRASG12V) which are currently in
IND-enabling development, RMC-8839 (KRASG13C), and additional
compounds targeting other RAS variants. RAS Companion Inhibitors in
clinical development include RMC-4630 (SHP2) and RMC-5552
(mTORC1/4EBP1).
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 company’s development plans and
timelines and its ability to advance its portfolio and R&D
pipeline; progression of clinical studies and findings from these
studies, including the tolerability and potential efficacy of the
company’s candidates being studied; the potential advantages and
effectiveness of the company’s clinical and preclinical candidates,
including its RAS(ON) Inhibitors; the validation of the company’s
platform; the company’s goal of bringing therapies to cancer
patients; and the company’s expectations regarding the potential
market size and size of the potential patient populations for the
company’s product candidates, if approved for commercial use.
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 the company’s 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
the company’s business of global events and other macroeconomic
conditions. 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 8, 2023, 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.
Investors & Media Contact:
Erin Graves
650-779-0136
egraves@revmed.com
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