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Revolution Medicines Shares Promising Data on Zoldonrasib for Lung Cancer
Revolution Medicines announced positive clinical data for zoldonrasib, aimed at treating KRAS G12D mutant non-small cell lung cancer (NSCLC).
Overview of Clinical Findings
Revolution Medicines, Inc. recently shared new clinical findings for zoldonrasib (RMC-9805), a selective inhibitor focused on KRAS G12D mutations in NSCLC patients. This data was presented at the American Association for Cancer Research Annual Meeting. The study results indicate an acceptable safety profile and promising initial antitumor activity, featuring a 61% objective response rate among patients who were evaluable for efficacy. In total, 90 patients participated in the Phase 1 study, which reported manageable treatment-related adverse events mainly categorized as Grade 1 or 2. The company is dedicated to the further development of zoldonrasib as well as other targeted therapies for patients with RAS-addicted cancers.
Positive Aspects of Zoldonrasib
- Newly reported clinical data indicates zoldonrasib (RMC-9805) shows good safety and tolerability along with promising initial antitumor effects in KRAS G12D mutant NSCLC patients.
- The reported objective response rate is 61%, with a disease control rate of 89%, highlighting effectiveness in a patient population with significant unmet needs.
- Zoldonrasib has a favorable safety profile, with no dose-limiting toxicities observed, supporting continued clinical development.
- Presenting this data at a high-profile conference (AACR Annual Meeting) enhances the company’s visibility and credibility, potentially attracting interest from investors and collaborators.
Concerns and Limitations
- Results come from a small patient subset, raising questions about the generalizability and reliability of the efficacy claims.
- Reported treatment-related adverse events include notable side effects such as nausea, diarrhea, and vomiting, which may affect patient tolerability.
- The press release includes several forward-looking statements that indicate substantial risks and uncertainties in the drug development process, which could affect investor confidence.
Frequently Asked Questions
What is zoldonrasib (RMC-9805)?
Zoldonrasib is a RAS(ON) G12D-selective inhibitor designed for KRAS G12D mutant non-small cell lung cancer patients.
What were the results of the RMC-9805-001 study?
The study showed a 61% objective response rate and an 89% disease control rate for patients treated with zoldonrasib.
How was the safety profile of zoldonrasib?
Zoldonrasib exhibited an acceptable safety profile, with most adverse events categorized as mild (Grade 1 or 2).
When were the clinical data for zoldonrasib presented?
The new clinical data was presented at the AACR Annual Meeting on April 27, 2025.
What are the future plans for zoldonrasib?
Revolution Medicines intends to further evaluate zoldonrasib as a stand-alone treatment and in combination therapies for challenging cancers.
Disclaimer: This is a summary of a press release distributed by GlobeNewswire, which may contain inaccuracies. View the full release here.
$RVMD Insider Trading Activity
Insiders at $RVMD have executed 23 trading transactions in the past six months. This includes two purchases and 21 sales.
Here’s a summary of recent insider trading for $RVMD:
- THILO SCHROEDER purchased 1,304,347 shares for approximately $59,999,962 with no sales.
- MARK A GOLDSMITH sold 93,452 shares for around $4,868,888 with no purchases.
- STEPHEN MICHAEL KELSEY sold 24,623 shares for about $1,317,825 with no purchases.
- JEFF CISLINI (General Counsel) sold 16,058 shares for roughly $806,784 with no purchases.
- MARGARET A HORN (Chief Operating Officer) sold 7,387 shares for around $315,938 with no purchases.
- SUSHIL PATEL sold 5,000 shares for an estimated $270,714.
- JACK ANDERS (Chief Financial Officer) sold 4,499 shares for about $192,410 with no purchases.
$RVMD Hedge Fund Activity
Recently, 165 institutional investors increased their positions in $RVMD, while 94 reduced their holdings in the latest quarter.
Here are some significant recent trades:
- JANUS HENDERSON GROUP PLC added 3,346,755 shares (+54.5%) in Q4 2024, valued at approximately $146,387,063.
- VANGUARD GROUP INC increased their portfolio by 2,185,082 shares (+14.7%) for about $95,575,486.
- FARALLON CAPITAL MANAGEMENT LLC added 1,931,000 shares (+17.1%) for an estimated $84,461,940.
- NEXTECH INVEST LTD. increased holdings by 1,304,347 shares (+20.7%) for around $57,052,137.
- PARADIGM BIOCAPITAL ADVISORS LP raised their position with 1,239,022 shares (+23.3%) for about $54,194,822.
- FMR LLC increased their portfolio by 866,190 shares (+14.7%) for approximately $37,887,150.
- BLACKROCK, INC. added 852,690 shares (+6.1%) for around $37,296,660.
$RVMD Analyst Ratings
In recent months, Wall Street analysts have issued ratings on $RVMD, with one firm recommending a buy and none issuing sell ratings.
Here is a recent analyst rating:
- UBS issued a “Buy” rating on January 8, 2025.
$RVMD Price Targets
Several analysts have set price targets for $RVMD in the last six months, with a median target of $67.00.
Recent target prices include:
- Benjamin Burnett from Stifel Nicolaus set a target of $64.00 on April 1, 2025.
- Eliana Merle from UBS set a target of $71.00 on January 8, 2025.
- Joseph Catanzaro from Piper Sandler set a target of $70.00 on November 7, 2024.
- Raghuram Selvaraju…
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Revolution Medicines Highlights Positive Data for Zoldonrasib in Lung Cancer
New Clinical Findings Presented at AACR Annual Meeting
REDWOOD CITY, Calif., April 27, 2025 (GLOBE NEWSWIRE) — Revolution Medicines, Inc. (Nasdaq: RVMD), a clinical-stage oncology company focused on targeted therapies for RAS-addicted cancers, announced promising clinical results for zoldonrasib (RMC-9805). This selective inhibitor targets RAS(ON) G12D mutations in patients with KRAS G12D mutant non-small cell lung cancer (NSCLC). The findings were part of the official press program at the American Association for Cancer Research (AACR) Annual Meeting held in Chicago, Illinois, and will be discussed in a late-breaking oral presentation on April 27, 2025, at 5:00 p.m. Central Time.
“We are excited to share new data for zoldonrasib, our oral RAS(ON) G12D-selective inhibitor, which demonstrates acceptable safety, tolerability, and promising early antitumor activity in NSCLC patients,” stated Mark A. Goldsmith, M.D., Ph.D., CEO and Chairman of Revolution Medicines. “These results reinforce the clinical potential of zoldonrasib, following our earlier findings in patients with pancreatic ductal adenocarcinoma. This supports further evaluation of zoldonrasib both as a standalone treatment and in combination therapies as we strive to provide innovative options for those with challenging cancers.”
Study Design and Results
RMC-9805-001 is an open-label, multicenter, dose-escalation and expansion Phase 1 study aimed at assessing zoldonrasib in patients with advanced solid tumors harboring a KRAS G12D mutation.
As of December 2, 2024, data cutoff, 90 solid tumor patients received 1200 mg of zoldonrasib once daily (QD), identified as the recommended Phase 2 dose. The treatment demonstrated a favorable safety profile consistent with previous data for this compound in pancreatic cancer, showing good tolerability.
The most frequently reported treatment-related adverse events (TRAEs), occurring in at least 10% of patients, included nausea (39%), diarrhea (24%), vomiting (18%), and rash (12%). Most TRAEs were of Grade 1 or 2 severity, with only two patients (2%) experiencing Grade 3 events that resolved after dose interruption. Zoldonrasib achieved a favorable mean dose intensity of 98%, with no dose-limiting toxicities reported.
Preliminary antitumor activity was evaluated in 18 efficacy-evaluable patients with NSCLC at the 1200 mg QD dose. The objective response rate (confirmed or pending confirmation) was found to be 61% (n=11), while the disease control rate was 89% (n=16).
Expert Commentary
“There is a significant unmet need for new treatments as no targeted therapies are currently approved for RAS G12D mutant cancers,” said Kathryn Arbour, M.D., thoracic medical oncologist at Memorial Sloan Kettering Cancer Center and principal investigator leading the RMC-9805-001 presentation. “While these findings come from a small, early-stage patient group, the level of tolerability and antitumor activity observed is encouraging.”
About Revolution Medicines, Inc.
Revolution Medicines is a clinical-stage oncology company developing targeted therapies for patients with RAS-addicted cancers. Its research pipeline includes RAS(ON) inhibitors aimed at suppressing various oncogenic variants of RAS proteins. Current clinical candidates include daraxonrasib (RMC-6236), a multi-selective inhibitor; elironrasib (RMC-6291), a G12C-selective inhibitor; and zoldonrasib (RMC-9805), a G12D-selective inhibitor. The company expects RMC-5127, a G12V-selective inhibitor, to commence clinical development soon. Additional development focuses on RAS(ON) mutant-selective inhibitors such as RMC-0708 (Q61H) and RMC-8839 (G13C).
Forward-Looking Statements
This press release contains forward-looking statements as defined by the U.S. Private Securities Litigation Reform Act of 1995. Statements not based on historical facts may be considered forward-looking, including those related to the safety, tolerability, and antitumor activity of the company’s drug candidates, clinical trial progression, and the potential therapeutic value of zoldonrasib.
Forward-looking statements typically include terms like “may,” “will,” “expect,” “anticipate,” and similar language indicating future outcomes. Such statements are subject to substantial risks and uncertainties, which could lead to results differing materially from those anticipated. Risks include the drug development process, challenges of clinical trials, and regulatory approvals, among others. For a more detailed discussion of risks that could affect actual results, refer to Revolution Medicines’ Annual report filed with the SEC and future periodic reports.
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