Revolution Medicines NASDAQ: RVMD highlighted what executives described as “practice-changing” phase 3 results for its RAS(ON) inhibitor daraxonrasib in previously treated metastatic pancreatic cancer, outlined a broadened registrational strategy across pancreatic and lung cancers, and reported a larger first-quarter net loss driven by accelerated clinical investment and higher stock-based compensation.
RASolute 302: Daraxonrasib improves survival versus chemotherapy
Chairman and CEO Dr. Mark Goldsmith said the company’s “tremendous progress” in 2026 was anchored by last month’s top-line readout from RASolute 302, a global phase 3 study evaluating daraxonrasib monotherapy in patients with previously treated metastatic pancreatic cancer.
Goldsmith said daraxonrasib met the trial’s primary and key secondary endpoints, showing “statistically significant and clinically meaningful improvement” in progression-free survival and overall survival compared with standard-of-care chemotherapy. In the overall intent-to-treat population (including patients with or without an identified RAS mutation), he said daraxonrasib drove a 60% reduction in risk of death versus chemotherapy, with median overall survival exceeding one year. He added that daraxonrasib was generally well tolerated and that no new safety signals were observed.
Goldsmith said the company plans to submit a U.S. new drug application under the FDA Commissioner’s National Priority Voucher Program and also intends to file with other global regulators. He noted the FDA has issued a “safe to proceed” letter allowing an expanded access treatment protocol for daraxonrasib in previously treated metastatic pancreatic cancer in the U.S. The company also said RASolute 302 will be presented in the plenary session at this year’s ASCO annual meeting.
Expanded access demand and the treated population in pancreatic cancer
On the question-and-answer portion of the call, Goldsmith said demand for expanded access “has been very clear from the moment that it was announced,” adding that calls began “within minutes” of the announcement. He said the company is putting resources behind meeting that need, but he could not project how many patients may ultimately be served through the program.
Chief Medical Officer Dr. Wei Lin provided context on the potential treated population based on clinical practice patterns. Lin said roughly 60,000 Americans are newly diagnosed each year with pancreatic cancer and that about 50% to 60% are diagnosed with metastatic disease. Typically, Lin said, due to the disease’s aggressive nature and chemotherapy toxicity, “about half” of patients receiving first-line metastatic treatment go on to receive subsequent second-line therapy.
Later in the call, Goldsmith said the expanded access eligible population includes “previously treated” patients and extends beyond the strict second-line population studied in RASolute 302.
Pipeline and registrational plans across pancreatic and lung cancers
Dr. Alan Sandler, chief development officer, reviewed clinical and program updates across the company’s RAS(ON) inhibitor portfolio, including data presented at the American Association for Cancer Research meeting.
In first-line metastatic pancreatic cancer, Sandler pointed to updated phase 1/2 results for daraxonrasib:
- Monotherapy cohort: median progression-free survival and overall survival were not mature at the data cutoff; Kaplan-Meier estimates at six months were 71% for progression-free survival and 83% for overall survival.
- Combination with gemcitabine and nab-paclitaxel: Kaplan-Meier estimates at six months were 84% for progression-free survival and 90% for overall survival.
Sandler said safety and tolerability were consistent with earlier findings and that no new safety signals were observed. He said these data support accelerating RASolute 303, a phase 3 study evaluating daraxonrasib monotherapy and daraxonrasib plus chemotherapy in first-line metastatic pancreatic cancer, which is enrolling globally. Enrollment is also ongoing in RASolute 304, a registrational trial of daraxonrasib monotherapy in the adjuvant setting after surgery and perioperative chemotherapy.
For zoldonrasib, the company’s covalent RAS(ON) G12D-selective inhibitor, Sandler said Revolution Medicines initiated RASolute 305, a randomized, double-blind, placebo-controlled registrational trial evaluating zoldonrasib plus investigator’s choice of chemotherapy (gemcitabine/nab-paclitaxel or modified FOLFIRINOX) versus placebo plus chemotherapy in first-line pancreatic cancer. He added the company remains on track to initiate RASolute 309 in the second half of the year, its first registrational study evaluating the doublet combination of zoldonrasib plus daraxonrasib.
Goldsmith emphasized that chemotherapy remains the current standard of care comparator in pancreatic cancer trials until regulators approve an alternative standard. He said the company has “high confidence” the zoldonrasib-plus-daraxonrasib combination can deliver results differentiated from chemotherapy and “even from monotherapy,” while also arguing for offering multiple options given patient-specific needs.
In non-small cell lung cancer, Sandler said the company continues enrolling patients in RASolve 301, a global randomized trial of daraxonrasib monotherapy in previously treated patients. He said the company is expanding the study to increase statistical power for overall survival, one component of a dual primary endpoint. During Q&A, management said the trial is being increased from 420 to 590 patients, and Goldsmith said the company does not expect the expansion to change the timing of readout given the current pace of enrollment; Sandler said the company anticipates substantially completing enrollment this year.
Sandler also reviewed updated zoldonrasib monotherapy data in G12D non-small cell lung cancer presented at AACR in patients previously treated with immune checkpoint inhibitors and platinum chemotherapy. He reported a confirmed objective response rate of 52%, a disease control rate of 93%, and a median progression-free survival of 11.1 months. Overall survival data were immature, with an estimated 12-month survival rate of 73% and median overall survival not yet reached.
Building on those data, Sandler said the company is preparing to initiate RASolve 308 in the first half of the year, a global, double-blind, placebo-controlled registrational trial evaluating zoldonrasib plus the KEYNOTE-189 regimen versus KEYNOTE-189 plus placebo.
Goldsmith said the company expects to disclose plans regarding daraxonrasib combination therapy in first-line non-small cell lung cancer this year. In response to a question about variables affecting first-line strategy, he cited patients being dosed with ivonescimab and said it “points towards potentially becoming the new standard of care” in first-line non-small cell lung cancer, which the company needs to consider.
Early-stage R&D: RMC-5127 and catalytic RAS(ON) inhibitor RM-055
Sandler said the company continues enrolling patients in the first-in-human trial of RMC-5127, a RAS G12V-selective RAS(ON) inhibitor, and expects to identify a recommended phase 2 monotherapy dose in the second half of 2026.
He also highlighted preclinical data for a new class of mutant-targeted catalytic RAS(ON) inhibitors, designed to promote conversion of mutant RAS from the active GTP-bound RAS(ON) state to the inactive GDP-bound RAS(OFF) state. Sandler said AACR preclinical data showed RM-055 achieved “robust and durable antitumor activity” across KRAS G12 mutant xenograft models in pancreatic cancer, non-small cell lung cancer, and colorectal cancer at well-tolerated doses. He added that tumors that had escaped prior RAS inhibitor treatment were sensitive to RM-055, which drove “deep and durable regression,” and said the company remains on track to initiate a first-in-human clinical trial in the fourth quarter.
During Q&A, President of R&D Dr. Steve Kelsey said RM-055 appears, in the company’s experiments, to be a “better inhibitor of flux” through the RAS pathway in settings of increased pathway signaling, particularly with G12 mutations. He said escape from daraxonrasib can occur through reactivation of RAS pathway signaling beyond mutant allele amplification, and that RM-055 may be effective beyond “pure RAS mutant amplification.” On therapeutic index, Kelsey said the approach is tied to differences between cancer and normal tissue in the importance of catalyzing active RAS back to RAS(OFF), adding that the drug has “almost negligible effect on normal tissue” and “very significant increased deactivation of mutant RAS in cancer cells.”
Commercial buildout and financial results
Goldsmith said the company continues building commercialization infrastructure to support global ambitions, initially focused in the U.S. and extending into priority international regions. He said Revolution Medicines recently appointed regional leaders including Neil MacGregor as General Manager for APAC, Tetsuo Endo as General Manager for Japan, and Martin Voelkl as General Manager for Germany.
Chief Global Commercialization Officer Anthony Mancini said the company is in the “final stages” of building out U.S. field-based teams across medical affairs, market access, and sales. He said the company has had an MSL team and thought leader liaison team in place “for quite some time,” along with a market access account team engaging payers and organized customers through pre-approval information exchange. Mancini said the company is in the final stages of onboarding its U.S. sales force, describing team members as having experience across GI malignancies and oral oncology and saying they would be “fully trained and ready to go” if FDA approval is received.
On the financials, CFO Jack Anders said Revolution Medicines ended the first quarter of 2026 with $1.9 billion in cash and investments. He added the company strengthened its position after quarter-end with $2.1 billion in net proceeds from concurrent upsized offerings of common stock and convertible debt in April.
Anders highlighted higher stock-based compensation expense of $87.3 million in the quarter ended March 31, 2026, compared with $25.1 million in the year-ago quarter. He attributed the increase to an update to the company’s equity compensation program introducing retirement benefits for certain employees, which resulted in $44.6 million of incremental stock-based compensation due to accelerated recognition. Anders said the company expects “higher non-recurring lumpiness” in stock-based compensation in the first half of 2026, with expense decreasing and returning to a more normalized trajectory in the second half.
As a result, Anders said the company increased its estimate of full-year 2026 stock-based compensation expense by about $80 million and now expects full-year stock-based compensation of $260 million to $280 million. He also said the company updated projected GAAP operating expense guidance and now expects full-year GAAP operating expenses of $1.7 billion to $1.8 billion.
For the quarter, R&D expense was $344.0 million versus $205.7 million a year ago, driven primarily by higher clinical trial and manufacturing expenses for daraxonrasib and zoldonrasib as programs accelerated and expanded, along with higher headcount and stock-based compensation. G&A expense was $101.3 million versus $35.0 million a year ago, which Anders attributed primarily to higher stock-based compensation, increased headcount, increased commercial preparation activities, and higher administrative costs. Net loss was $453.8 million compared with $213.4 million in the first quarter of 2025.
About Revolution Medicines NASDAQ: RVMD
Revolution Medicines is a clinical-stage biopharmaceutical company focused on discovering and developing small molecule therapies to treat RAS-dependent cancers and other diseases driven by the RAS/MAPK pathway. The company's research efforts target historically “undruggable” proteins, aiming to inhibit critical nodes in cell signaling that promote tumor growth and therapeutic resistance.
The lead pipeline includes RMC-4630, a SHP2 inhibitor; RMC-6291, a selective KRAS G12C inhibitor; and RMC-6236, a pan-RAS inhibitor designed to address multiple RAS mutations.
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