Revolution Medicines to Present Updated Phase 1 Clinical Data for Zoldonrasib in Patients with Previously Treated KRAS G12D Non-Small Cell Lung Cancer at the 2026 AACR Annual Meeting

Rhea-AI Summary

Revolution Medicines (Nasdaq: RVMD) presented updated Phase 1 (RMC-9805-001) data for zoldonrasib, a KRAS G12D-selective oral inhibitor, at AACR 2026 on April 19, 2026. Data (cutoff Dec 1, 2025) included 40 safety-evaluable NSCLC patients at 1,200 mg daily and an efficacy subset (n=27) with prior checkpoint inhibitor and platinum chemotherapy.

Key results: confirmed objective response rate 52%, disease control rate 93%, median PFS 11.1 months, median duration of response not yet estimable, and manageable safety with Grade 3 TRAEs in 13%.

AI-generated analysis. Not financial advice.

Positive

• Confirmed ORR 52% in efficacy subset (n=27)
• Disease control 93% in efficacy-evaluable patients
• Median PFS 11.1 months (95% CI: 5.3, NE)
• Mean dose intensity 94% at the recommended Phase 2 dose
• Estimated 12-month OS 73% (95% CI: 52, 86)

Negative

• Grade 3 treatment-related adverse events occurred in 13% of patients
• Common GI toxicities: nausea 43%, vomiting 33%, diarrhea 30%
• Treatment discontinuation due to TRAEs in 5% of patients
• Efficacy data based on a small subset (n=27) with specific prior therapies

Key Figures

NSCLC patients (safety): 40 patients Efficacy subset size: 27 patients Objective response rate: 52% (CI: 32–71) +5 more

8 metrics

NSCLC patients (safety) 40 patients KRAS G12D NSCLC at 1200 mg once daily, evaluable for safety

Efficacy subset size 27 patients Prior ICI and platinum, no prior docetaxel, evaluable for response

Objective response rate 52% (CI: 32–71) Confirmed ORR in 27-patient efficacy subset

Disease control rate 93% (CI: 76–99) DCR in same KRAS G12D NSCLC efficacy subset

Median PFS 11.1 months (95% CI: 5.3–not estimable) KRAS G12D NSCLC efficacy subset

12-month PFS rate 48% (95% CI: 27–66) Estimated progression-free survival at 12 months

12-month OS rate 73% (95% CI: 52–86) Estimated overall survival at 12 months; OS data immature

Grade 3 TRAEs 13% of patients Higher-grade treatment-related adverse events, no Grade 4/5 observed

Market Reality Check

Price: $149.47 Vol: Volume 4,703,040 is 29% a...

normal vol

$149.47 Last Close

Volume Volume 4,703,040 is 29% above 20-day average 3,632,342, indicating elevated pre-news interest. normal

Technical Price 148.63 is well above 200-day MA 71.19, reflecting a strong established uptrend and proximity to the 155.70 52-week high.

Peers on Argus

RVMD traded near its 52-week high with a modest -0.43% move while key biotech pe...

RVMD traded near its 52-week high with a modest -0.43% move while key biotech peers showed mixed, mostly small moves (e.g., BPMC +0.09%, VRNA +0.06%, MRNA -3.55%), supporting a stock-specific setup rather than a sector-wide driver.

Previous Clinical trial Reports

5 past events · Latest: Apr 13 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Apr 13	Phase 3 OS data	Positive	+41.4%	Phase 3 RASolute 302 showed large OS benefit versus chemotherapy in PDAC.
Apr 02	Phase 3 trial start	Positive	+0.5%	Initiation of RASolute 303 Phase 3 trial in first-line metastatic PDAC.
Jan 29	First-in-human dosing	Positive	+0.9%	First patient dosed in RMC-5127-001 trial for RAS G12V-selective inhibitor.
Dec 18	Phase 3 enrollment	Positive	-1.0%	First patient randomized in RASolute 304 adjuvant PDAC Phase 3 trial.
Oct 27	Orphan designation	Positive	+6.4%	FDA Orphan Drug Designation granted to daraxonrasib in pancreatic cancer.

Pattern Detected

Clinical trial announcements have generally been followed by positive stock reactions, especially for major Phase 3 updates, with only one recent instance of the stock dipping on otherwise positive trial progress.

Recent Company History

Over the past several months, Revolution Medicines has repeatedly highlighted progress in its RAS(ON) pipeline. Key milestones include strong Phase 3 RASolute 302 data in metastatic pancreatic cancer on Apr 13, 2026 with a 41.35% move, and initiation of the Phase 3 RASolute 303 trial on Apr 2, 2026. Earlier updates covered first patient randomization in RASolute 304 and FDA Orphan Drug Designation for daraxonrasib. Today’s zoldonrasib Phase 1 NSCLC data fits this pattern of steady clinical advancement across multiple RAS-driven cancers.

Historical Comparison

+9.6% avg move · Across five prior clinical-trial headlines, RVMD moved an average of 9.63%, with the strongest react...

clinical trial

+9.6%

Average Historical Move clinical trial

Across five prior clinical-trial headlines, RVMD moved an average of 9.63%, with the strongest reaction tied to pivotal Phase 3 pancreatic cancer data. This zoldonrasib update extends that clinical momentum.

Clinical news has progressed from early RAS(ON) programs entering first-in-human studies to multiple daraxonrasib Phase 3 trials and now robust Phase 1 zoldonrasib data in KRAS G12D NSCLC.

Market Pulse Summary

This announcement highlights promising Phase 1 data for zoldonrasib in KRAS G12D NSCLC, with a 52% o...

Analysis

This announcement highlights promising Phase 1 data for zoldonrasib in KRAS G12D NSCLC, with a 52% objective response rate, 93% disease control rate, and median PFS of 11.1 months in a heavily pretreated subset. It extends a pattern of steady clinical progress across RVMD’s RAS(ON) pipeline. Investors may watch for larger datasets, durability of response, and how these results compare with emerging targeted options for RAS-driven lung cancers.

Key Terms

non-small cell lung cancer, treatment-related adverse events, objective response rate, disease control rate, +4 more

8 terms

non-small cell lung cancer medical

"patients with previously treated KRAS G12D non-small cell lung cancer (NSCLC)."

A broad category of lung tumors that grow from the cells lining the airways and make up the majority of lung cancer cases; it includes several subtypes that behave and respond to treatment differently, like different models of the same car family. It matters to investors because its large patient population and variety of treatment options — surgery, traditional chemo, targeted drugs and immunotherapies — create major markets where clinical trial results, drug approvals or changing treatment guidelines can quickly affect a company’s revenue and stock value.

treatment-related adverse events medical

"Treatment-related adverse events (TRAEs) of any grade occurring in at least 15% of patients"

Treatment-related adverse events are harmful or unwanted health effects that doctors or regulators determine were caused by a drug, vaccine, device, or other medical therapy. Investors care because how often and how severe these side effects are can shape regulatory approval, labeling, sales potential and legal risk — similar to how product defects can stop or damage a company's ability to sell an item.

objective response rate medical

"the confirmed objective response rate was 52% (confidence interval (CI): 32, 71)"

The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.

disease control rate medical

"and the disease control rate was 93% (CI: 76, 99)."

The disease control rate is the share of patients in a clinical trial whose cancer or condition either shrinks or stops getting worse for a specified period after treatment. Think of it like the percentage of people for whom a treatment hits pause or nudges back the problem rather than letting it progress; higher rates suggest the therapy can meaningfully limit disease, which matters to investors assessing a drug’s potential efficacy and commercial value.

progression-free survival medical

"Median progression-free survival (PFS) was 11.1 months (95% CI: 5.3, not estimable)"

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

"Overall survival (OS) data were immature at the time of analysis"

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.

immune checkpoint inhibitor medical

"subset of patients with prior immune checkpoint inhibitor and platinum chemotherapy"

An immune checkpoint inhibitor is a type of medicine that helps the body's immune system recognize and attack cancer cells more effectively. It works by blocking certain signals that cancer uses to hide from immune defenses, allowing the immune system to target tumors. This breakthrough has led to new cancer treatments, making immune checkpoint inhibitors an important area of growth and innovation in the healthcare industry.

confidence interval technical

"confirmed objective response rate was 52% (confidence interval (CI): 32, 71)"

An interval estimate that shows a range of values within which a true number (like a company’s expected earnings, a projected return, or a model input) is likely to lie, together with a stated level of confidence in that range. For investors it turns a single point forecast into a band—like a weather forecast saying 60–70°F instead of just 65°F—making uncertainty explicit so you can judge risk and size positions more sensibly.

AI-generated analysis. Not financial advice.

REDWOOD CITY, Calif., April 19, 2026 (GLOBE NEWSWIRE) -- Revolution Medicines, Inc. (Nasdaq: RVMD), a late-stage clinical oncology company developing targeted therapies for patients with RAS-addicted cancers, today announced updated Phase 1 (RMC-9805-001) clinical data for zoldonrasib, an oral RAS(ON) G12D-selective inhibitor, in patients with previously treated KRAS G12D non-small cell lung cancer (NSCLC). Results were highlighted in the official press program at the American Association for Cancer Research (AACR) Annual Meeting and will be featured in a plenary oral presentation today, April 19, 2026, at 1:30 p.m. PDT.

“Patients with RAS G12D non-small cell lung cancer remain a population with a significant unmet medical need for targeted therapeutic options,” said Jonathan Riess M.D., medical director of thoracic oncology at UC Davis Comprehensive Cancer Center and principal investigator for the RMC-9805-001 trial. “The manageable safety profile and evidence of clinical activity in this Phase 1 trial are encouraging and support the continued clinical development of zoldonrasib.”

“We believe these updated data further strengthen the profile of zoldonrasib as a potentially important targeted therapy for patients with RAS G12D non-small cell lung cancer where historical treatment options, such as chemotherapy, have offered limited benefit, and are often associated with considerable toxicity,” said Alan Sandler, M.D., chief development officer of Revolution Medicines. “The emerging profile supports advancing zoldonrasib across monotherapy and combination settings in lung cancer and other RAS G12D-driven cancers.”

Summary of Phase 1 Zoldonrasib Data at AACR 2026 (Abstract # CT021)

RMC-9805-001 is a multicenter, open-label, dose escalation and dose expansion Phase 1 trial designed to evaluate zoldonrasib in patients with advanced solid tumors harboring a KRAS G12D mutation. The data to be presented at the AACR Annual Meeting are as of a December 1, 2025 data cutoff, and included 40 patients with KRAS G12D NSCLC treated with zoldonrasib 1200 mg once daily, the recommended Phase 2 dose, and who were evaluable for safety. Efficacy analyses were conducted in a subset of patients with prior immune checkpoint inhibitor and platinum chemotherapy and no prior docetaxel treatment who had sufficient follow-up for response assessment (n=27).

Zoldonrasib was generally well tolerated and demonstrated a safety profile consistent with previously reported findings. Treatment-related adverse events (TRAEs) of any grade occurring in at least 15% of patients were nausea (43%), vomiting (33%), diarrhea (30%), and rash (18%). The majority of TRAEs were Grade 1 in severity. Grade 3 TRAEs occurred in 13% of patients and resolved following dose interruption; TRAEs led to treatment discontinuation in 5% of patients. No Grade 4 or Grade 5 TRAEs were observed. Zoldonrasib demonstrated a favorable mean dose intensity of 94%.

Zoldonrasib demonstrated encouraging clinical activity in patients with KRAS G12D NSCLC previously treated with immune checkpoint inhibitor and platinum chemotherapy and no prior docetaxel. Among this subset of patients (n=27), the confirmed objective response rate was 52% (confidence interval (CI): 32, 71) and the disease control rate was 93% (CI: 76, 99). Median time to response was 1.4 months and median duration of response was not yet estimable (95% CI: 8.3, not estimable). Median progression-free survival (PFS) was 11.1 months (95% CI: 5.3, not estimable), with an estimated 12-month PFS rate of 48% (95% CI: 27, 66). Overall survival (OS) data were immature at the time of analysis, and median OS was not yet reached with median potential follow-up of 13.1 months (range: 9.1–19.9). Estimated survival rate at 12 months was 73% (95% CI: 52, 86), suggesting encouraging early survival outcomes.

About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) accounts for 80%-85% of all lung cancers, with more than 229,000 people diagnosed in the U.S. each year.^1,2 Despite treatment advancements, NSCLC remains a leading cause of cancer-related mortality worldwide, primarily due to its late-stage diagnosis and limited response to conventional therapies. KRAS G12D is the most common oncogenic driver of human cancers and represents 4% of NSCLC cases.³

About Zoldonrasib
Zoldonrasib is a tri-complex inhibitor that binds to cyclophilin A, creating a complex that selectively recognizes and inhibits the active, oncogenic RAS G12D(ON) mutant. KRAS G12D is the most prevalent RAS mutation, accounting for 29% of all RAS cancers, and currently lacks an approved targeted therapy.⁴ Across tumor types, approximately 61,000 new patients with RAS G12D cancers are estimated each year in the United States.⁵ Zoldonrasib is currently being evaluated as a monotherapy and in combination with other therapies, including with Revolution Medicines’ RAS(ON) multi-selective inhibitor daraxonrasib (RMC-6236), as well as standard of care regimens in lung and gastrointestinal cancers.

About Revolution Medicines, Inc.
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. Additional development opportunities in the company’s pipeline focus on RAS(ON) mutant-selective inhibitors, including RMC-0708 (Q61H) and RMC-8839 (G13C). For more information, please visit www.revmed.com and follow us on LinkedIn.

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 strategy and its ability to build or advance its portfolio and R&D pipeline; progression of clinical studies and findings from these studies, including the tolerability, safety, and potential efficacy of the company’s candidates being studied; and the potential of zoldonrasib as a therapeutic option for RAS G12D-driven cancers.

Forward-looking statements are typically, but not always, identified by the use of words such as “aims,” “anticipate,” "believe," "estimate," "expect," "plan," “potential,” “project,” “up to,” "will" 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 the 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 Revolution Medicines in general, see Revolution Medicines’ 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, 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.

Revolution Medicines Media & Investor Contact:
media@revmed.com
investors@revmed.com

¹ American Cancer Society. What is Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/what-is.html. Accessed April 2026.
² American Cancer Society. Key Statistics for Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed April 2026.
³ Ricciuti B, Alessi JV, Elkrief A, et al. Dissecting the clinicopathologic, genomic, and immunophenotypic correlates of KRASG12D-mutated non-small-cell lung cancer. Ann Oncol. 2022;33(10): 1029-1040. doi:10.1016/j.annonc.2022.07.005
⁴ Lee JK, Sivakumar S, Schrock AB, et al. Comprehensive pan-cancer genomic landscape of KRAS altered cancers and real-world outcomes in solid tumors. NPJ Precis Oncol. 2022;6(1):91. doi:10.1038/s41698-022-00334-z
⁵ Estimated using tumor mutation frequencies from Foundation Medicine Insights March 2022 and scaled to estimated patient numbers using cancer incidence from ACS Cancer Facts and Figures 2023.

FAQ

What efficacy did RVMD report for zoldonrasib in KRAS G12D NSCLC at AACR 2026?

Zoldonrasib showed a confirmed ORR of 52% in the efficacy subset. According to the company, this was observed in 27 previously treated NSCLC patients with prior checkpoint inhibitor and platinum chemotherapy.

What was the median progression-free survival for RVMD's zoldonrasib in the Phase 1 NSCLC cohort?

Median PFS was 11.1 months in the reported subset. According to the company, the 95% CI was 5.3 months to not estimable, with an estimated 12-month PFS rate of 48%.

What safety profile did Revolution Medicines report for zoldonrasib (RVMD) in KRAS G12D NSCLC?

Zoldonrasib was generally well tolerated with mostly Grade 1 events; Grade 3 TRAEs occurred in 13%. According to the company, common TRAEs included nausea (43%), vomiting (33%) and diarrhea (30%).

What dose of zoldonrasib did RVMD use and how was dose intensity reported?

The recommended Phase 2 dose was 1,200 mg once daily, with a mean dose intensity of 94%. According to the company, 40 patients were evaluable for safety at that dose as of the Dec 1, 2025 cutoff.

Are overall survival results for RVMD's zoldonrasib mature from the AACR 2026 data?

Overall survival data were immature and median OS was not yet reached. According to the company, median potential follow-up was 13.1 months and the estimated 12-month survival rate was 73%.