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Daraxonrasib boosts survival in Phase 3 pancreatic cancer trial for Revolution Medicines (RVMD)

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Rhea-AI Filing Summary

Revolution Medicines reported strong topline results from its global Phase 3 RASolute 302 trial of oral daraxonrasib in previously treated metastatic pancreatic ductal adenocarcinoma. Daraxonrasib improved median overall survival to 13.2 months versus 6.7 months with standard intravenous chemotherapy, with a hazard ratio of 0.40 (p < 0.0001). The therapy also showed statistically significant, clinically meaningful gains in progression-free survival and was generally well tolerated, with a manageable safety profile and no new safety signals. Based on this first interim analysis, all progression-free and overall survival endpoints are considered final, and the company plans to submit these data to global regulators, including a future U.S. New Drug Application under a Commissioner’s National Priority Voucher.

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Insights

Phase 3 data show a large survival benefit for daraxonrasib in metastatic pancreatic cancer.

The Phase 3 RASolute 302 trial reports median overall survival of 13.2 months on daraxonrasib versus 6.7 months with standard chemotherapy, with a hazard ratio of 0.40 and p < 0.0001. The company also describes progression-free survival gains as statistically significant and clinically meaningful.

Pancreatic ductal adenocarcinoma has limited effective options after prior treatment, so a doubling of median overall survival is noteworthy. Daraxonrasib was generally well tolerated with no new safety signals, which supports its potential usability in a fragile patient population.

The endpoints are deemed final at this first interim analysis, and Revolution Medicines plans submissions to global regulators, including a U.S. New Drug Application under a Commissioner’s National Priority Voucher. Actual regulatory outcomes and any future commercial use will depend on agency review of the full data package.

Item 8.01 Other Events Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Median overall survival on daraxonrasib 13.2 months Intent-to-treat metastatic PDAC population in RASolute 302
Median overall survival on chemotherapy 6.7 months Comparator arm in RASolute 302 Phase 3 trial
Overall survival hazard ratio 0.40 Daraxonrasib vs. chemotherapy, intent-to-treat population
Statistical significance of OS benefit p < 0.0001 Overall survival comparison daraxonrasib vs. chemotherapy
progression-free survival medical
"demonstrated statistically significant and clinically meaningful improvements in progression-free survival"
Progression-free survival is the length of time during and after a treatment that a patient's disease does not get worse, measured from the start of treatment until the disease shows measurable signs of progression or the patient dies. Investors care because longer progression-free survival in clinical trials often signals that a drug is effective, improving chances of regulatory approval, market adoption, and revenue potential—think of it as a stopwatch showing how long a therapy can keep the illness at bay.
overall survival medical
"In the overall (intent-to-treat) study population, daraxonrasib demonstrated a median OS of 13.2 months"
Overall survival is the average or median length of time patients remain alive after starting a treatment or entering a clinical study, measured regardless of cause of death. Investors care because it is a clear, hard measure of a therapy’s real-world benefit — like timing how long a new battery actually runs — and strong improvements in overall survival can drive regulatory approval, market adoption and revenue potential.
hazard ratio medical
"with a hazard ratio of 0.40 (p < 0.0001)"
A hazard ratio is a way scientists compare the chance of something happening over time between two groups, like patients taking different medicines. If the ratio is high, it means one group is more likely to experience the event sooner or more often, which helps determine how effective a treatment is or how risky a situation might be.
New Drug Application regulatory
"including to the U.S. Food and Drug Administration as part of a future New Drug Application"
A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.
Commissioner’s National Priority Voucher regulatory
"under a Commissioner’s National Priority Voucher"
Understanding 8-K Material Events →
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): April 13, 2026

 

 

REVOLUTION MEDICINES, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   001-39219   47-2029180

(State or other jurisdiction

of incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

 

700 Saginaw Drive

Redwood City, California

   94063
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (650) 481-6801

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

☐

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

☐

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

☐

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

☐

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

 

Title of each class

  

Trading
Symbol

  

Name of each exchange

on which registered

Common Stock, $0.0001 par value per share   RVMD   The Nasdaq Stock Market LLC
Warrants to purchase 0.1112 shares of common stock expiring 2026   RVMDW   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

 
 

Item 8.01

Other Events.

On April 13, 2026, Revolution Medicines, Inc. (the “Company”) shared topline results from its global, randomized, controlled Phase 3 RASolute 302 clinical trial evaluating daraxonrasib in patients with metastatic pancreatic ductal adenocarcinoma (“PDAC”) who had been previously treated. Daraxonrasib taken orally once daily demonstrated statistically significant and clinically meaningful improvements in progression-free survival (“PFS”) and overall survival (“OS”) compared with standard of care cytotoxic chemotherapy delivered intravenously. In the overall (intent-to-treat) study population, daraxonrasib demonstrated a median OS of 13.2 months versus 6.7 months for chemotherapy, with a hazard ratio of 0.40 (p < 0.0001). Daraxonrasib was generally well tolerated, with a manageable safety profile, and with no new safety signals.

Based on the results from this first interim analysis, all PFS and OS endpoint results are considered final. The Company intends to submit these data to global regulatory authorities, including to the U.S. Food and Drug Administration as part of a future New Drug Application under a Commissioner’s National Priority Voucher.

Forward-Looking Statements

This Current Report on Form 8-K 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 potential advantages, including potential safety, tolerability, efficacy, and durability, of daraxonrasib; and the Company’s plans to submit data to global regulatory authorities. Forward-looking statements are typically, but not always, identified by the use of words such as “intend,” “anticipate,” “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’ development stages, 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, such as international conflicts or global pandemics. 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 (the “SEC”) on February 25, 2026, and its future periodic reports to be filed with the SEC. 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.

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

    REVOLUTION MEDICINES, INC.
Date: April 13, 2026     By:  

/s/ Mark A. Goldsmith

     

Mark A. Goldsmith, M.D., Ph.D.

President and Chief Executive Officer

Source: View Original Filing on SEC EDGAR

FAQ

What did Revolution Medicines (RVMD) report from the RASolute 302 Phase 3 trial?

Revolution Medicines reported topline Phase 3 RASolute 302 data showing daraxonrasib improved survival versus standard chemotherapy in previously treated metastatic pancreatic ductal adenocarcinoma. The company described the improvements in progression-free and overall survival as statistically significant and clinically meaningful, with a generally well-tolerated safety profile.

How much did daraxonrasib improve overall survival in RVMD’s trial?

Daraxonrasib achieved median overall survival of 13.2 months versus 6.7 months with standard intravenous chemotherapy in the intent-to-treat population. This corresponded to a hazard ratio of 0.40 with p < 0.0001, indicating a large and highly statistically significant survival benefit in metastatic pancreatic ductal adenocarcinoma.

What were the safety results for daraxonrasib in Revolution Medicines’ Phase 3 study?

Daraxonrasib was generally well tolerated in the RASolute 302 trial, with a manageable safety profile. The company stated that no new safety signals were observed, which is important given the advanced, previously treated metastatic pancreatic ductal adenocarcinoma population evaluated.

Are the RASolute 302 efficacy endpoints for daraxonrasib considered final?

Yes. Based on the first interim analysis of the RASolute 302 trial, Revolution Medicines stated that all progression-free survival and overall survival endpoint results are considered final. This means the key efficacy outcomes used to assess daraxonrasib’s benefit are not expected to change with additional follow-up.

What regulatory steps does Revolution Medicines plan after these daraxonrasib results?

Revolution Medicines intends to submit the RASolute 302 data to global regulatory authorities. The company plans to include the results in a future New Drug Application to the U.S. Food and Drug Administration, submitted under a Commissioner’s National Priority Voucher pathway.

What patient population was studied in RVMD’s daraxonrasib Phase 3 trial?

The RASolute 302 trial enrolled patients with metastatic pancreatic ductal adenocarcinoma who had been previously treated. These patients received once-daily oral daraxonrasib or standard-of-care intravenous cytotoxic chemotherapy in a randomized, controlled, global Phase 3 study design.

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