Major RASolute Trials Explained: How Daraxonrasib (Rasonque) Is Changing Pancreatic Cancer Treatment (2026)

Cancer Treatment & Research Updates · Last updated: September 11, 2026

A plain-language guide to the RASolute clinical trial program, the first FDA-approved RAS-targeted therapy, and what's coming next in lung and colorectal cancer.

Quick Answer

"RASolute" refers to a family of Phase 3 clinical trials of daraxonrasib, an oral RAS-targeting drug from Revolution Medicines, in pancreatic cancer (PDAC). The lead trial, RASolute 302, nearly doubled median overall survival compared to chemotherapy (13.2 vs. 6.7 months) in previously treated metastatic pancreatic cancer. Based on those results, the FDA approved daraxonrasib on August 26, 2026 under the brand name Rasonque — the first RAS inhibitor ever approved for pancreatic cancer. Two more RASolute trials (303 and 304) are testing it earlier in treatment, and a related but separately named trial family, "RASolve," is testing daraxonrasib and sister drugs in RAS-mutant lung cancer, with colorectal cancer studies also underway.

In This Guide

1. Why RAS Mutations Matter
2. What Is Daraxonrasib (Rasonque)?
3. RASolute 302: The Trial That Changed the Standard of Care
4. RASolute 303: Moving to First-Line Treatment
5. RASolute 304: Preventing Recurrence After Surgery
6. RASolute vs. RASolve: Avoiding the Mix-Up
7. Beyond Pancreatic Cancer: The Broader Pan-RAS Pipeline
8. How Strong Is the Evidence?
9. Side Effects to Discuss With Your Oncologist
10. Cost and Access
11. What This Means for You or a Loved One
12. Using AI Tools to Research Your Options
13. Frequently Asked Questions
14. Sources & References

Why RAS Mutations Matter

RAS genes (KRAS, NRAS, and HRAS) act like a molecular "on/off switch" that tells cells when to grow and divide. When RAS is mutated, that switch gets stuck in the "on" position, and cells multiply out of control. RAS mutations are among the most common cancer drivers in the world — found in more than 90% of pancreatic ductal adenocarcinoma (PDAC) cases, roughly 30% of non-small cell lung cancers (NSCLC), and about half of colorectal cancers (CRC).

For decades, RAS was considered "undruggable." Its smooth surface gave chemists almost nothing to grab onto, and early attempts to block it failed. The first RAS-targeted drugs to reach patients (sotorasib and adagrasib) only worked against one specific mutation, KRAS G12C, which is rare in pancreatic cancer and uncommon outside lung cancer. Most RAS-driven pancreatic and colorectal tumors carry other RAS variants that those drugs cannot touch.

The RASolute and RASolve trials matter because they test a different kind of molecule — one designed to work across a broad range of RAS mutations at once, rather than just one.

What Is Daraxonrasib (Rasonque)?

Daraxonrasib (lab code RMC-6236, brand name Rasonque) is a once-daily oral tablet developed by Revolution Medicines. It's described as a "RAS(ON) multi-selective" inhibitor: rather than permanently disabling RAS, it forms a three-part complex with a cellular protein called cyclophilin A and the active, GTP-bound ("ON") form of RAS. This blocks RAS from signaling through its downstream partners (RAF and related pathways), regardless of which specific mutation is driving the cancer — including G12, G13, and Q61 variants, and even RAS that isn't mutated at all (wild-type) in some tumors that still depend on it.

This broad, mutation-agnostic mechanism is why a single drug could plausibly work across pancreatic, lung, and colorectal cancers, which is exactly what the RASolute and RASolve trial programs are testing.

RASolute 302: The Trial That Changed the Standard of Care

RASolute 302 (NCT06625320) is the trial behind daraxonrasib's FDA approval. It enrolled 500 adults with metastatic PDAC whose cancer had progressed after one prior line of chemotherapy — a setting where options have historically been limited and survival has been measured in months.

Trial Design	Details
Phase / Type	Phase 3, randomized, open-label, global (1:1 allocation)
Population	Previously treated (2nd-line) metastatic PDAC, with or without a known RAS mutation
Arms	Daraxonrasib 300 mg orally once daily vs. investigator's choice of chemotherapy (gemcitabine, nab-paclitaxel, irinotecan, liposomal irinotecan, or 5-FU/leucovorin regimens)
Primary Endpoints	Progression-free survival (PFS) and overall survival (OS) in the RAS G12-mutant subgroup

Results

Outcome	Daraxonrasib	Chemotherapy
Median OS (RAS G12 population)	13.2 months	6.6 months (HR 0.40)
Median OS (overall population)	13.2 months	6.7 months (HR 0.40)
12-month survival rate	~53%	~17–19%
Median PFS (RAS G12 population)	7.3 months	3.5 months (HR 0.45)
Objective response rate (RAS G12)	33.2%	11.8%

HR = hazard ratio (0.40 means a 60% lower risk of death). All differences were highly statistically significant (p<0.0001). Results were presented as a plenary session at the 2026 ASCO Annual Meeting and published simultaneously in the New England Journal of Medicine.

Patients also reported delayed worsening of cancer-related pain and quality of life on daraxonrasib compared with chemotherapy — a meaningful secondary finding, since living longer matters most when it comes with preserved quality of life.

FDA Approval

On August 26, 2026, the FDA approved daraxonrasib as Rasonque for adults with metastatic pancreatic adenocarcinoma who have received at least one prior systemic therapy, or who aren't candidates for combination chemotherapy. The approval applies regardless of RAS mutation status and doesn't require a companion diagnostic test. The drug received Breakthrough Therapy and Orphan Drug designations, Priority Review, and was reviewed under the FDA's Commissioner's National Priority Voucher pilot program — arriving 6.5 months ahead of its original review deadline. The European Medicines Agency began an accelerated assessment of daraxonrasib in July 2026.

RASolute 303: Moving to First-Line Treatment

RASolute 303 (NCT07491445) asks whether daraxonrasib helps even more if used as a patient's very first treatment for metastatic PDAC, rather than waiting until after chemotherapy stops working. This global Phase 3 trial, which began treating patients in April 2026, compares two approaches — daraxonrasib alone, or daraxonrasib combined with standard gemcitabine/nab-paclitaxel chemotherapy — against gemcitabine/nab-paclitaxel alone. Primary endpoints are PFS and OS; secondary endpoints include response rate, safety, and patient-reported quality of life.

This trial builds on earlier Phase 1/2 data in which daraxonrasib monotherapy was generally well tolerated with no new safety signals in RAS-mutant PDAC patients. Results from RASolute 303 have not yet been reported; the trial is still enrolling and following patients.

RASolute 304: Preventing Recurrence After Surgery

RASolute 304 (NCT07252232) targets a very different population: patients whose pancreatic cancer was surgically removed and who have completed neoadjuvant and/or adjuvant chemotherapy. Pancreatic cancer recurs frequently even after apparently successful surgery, so this trial tests whether adding daraxonrasib afterward — compared to observation alone — can delay or prevent that recurrence.

The trial is expected to enroll around 500 patients with RAS-mutant, resected PDAC. Its primary endpoint is disease-free survival (time without cancer returning), with overall survival, safety, and tolerability as secondary endpoints. RASolute 304 is currently recruiting, and, like RASolute 303, has not yet reported results.

RASolute vs. RASolve: Avoiding the Mix-Up

Revolution Medicines uses two similar-sounding trial naming conventions, and it's easy to confuse them: "RASolute" trials (302, 303, 304) test daraxonrasib specifically in pancreatic cancer. "RASolve" trials (301, 307, 308) test daraxonrasib and its sister compounds in lung cancer. As of this writing, daraxonrasib/Rasonque is FDA-approved only for pancreatic cancer — it remains investigational (unapproved) for lung cancer, colorectal cancer, and earlier lines of pancreatic cancer treatment.

Beyond Pancreatic Cancer: The Broader Pan-RAS Pipeline

Revolution Medicines is running one of the largest RAS-targeting drug development programs in oncology, with several related molecules in testing across lung, pancreatic, and colorectal cancer. Here's the current picture:

Trial	Drug	Cancer Type	Status
RASolve 301 (NCT06881784)	Daraxonrasib vs. docetaxel	RAS-mutant NSCLC (previously treated)	Enrolling; readout expected 2027
RASolve 307 (planned)	Elironrasib + standard of care	1st-line RAS G12C-mutant NSCLC	Planned to start Q4 2026
RASolve 308 (initiated 2026)	Zoldonrasib + standard of care vs. placebo + SOC	1st-line RAS G12D-mutant NSCLC	Enrolling
RASolute 309 (planned)	Zoldonrasib + daraxonrasib (doublet)	Expected in pancreatic cancer, based on naming and early combination data	Planned; full details not yet published

The sister drugs

Unlike daraxonrasib's "multi-selective" approach, several companion drugs target one specific RAS mutation each — a strategy that may offer a more targeted side-effect profile for patients with that exact mutation:

• Zoldonrasib (RMC-9805) — selective for RAS G12D, the single most common RAS mutation in pancreatic cancer. Early combination data in first-line PDAC (with chemotherapy) and NSCLC (with chemo-immunotherapy) has shown high response rates, though follow-up remains short.
• Elironrasib (RMC-6291) — selective for RAS G12C, showing activity both in patients new to G12C-targeted drugs and those who've already tried one.
• RMC-5127 — selective for RAS G12V, still in earlier clinical development with less mature public data.

In colorectal cancer, Revolution Medicines is running multiple early-phase combination trials pairing its RAS(ON) inhibitors with chemotherapy and other investigational agents, including a collaboration with Summit Therapeutics testing combinations with the PD-1/VEGF bispecific antibody ivonescimab. A recommended Phase 2 dose is expected in the second half of 2026, with initial efficacy data anticipated in 2027. No Phase 3 colorectal trial has been named yet.

How Strong Is the Evidence?

Not all of these trials carry the same weight of evidence yet, and it's worth being clear-eyed about the difference:

Trial	Evidence Status
RASolute 302	Highest tier: completed randomized Phase 3 trial, peer-reviewed in NEJM, basis for FDA approval
RASolute 303 / 304	Phase 3 trials ongoing — no efficacy results yet; decisions should not be based on assumed outcomes
RASolve 301 / 307 / 308, colorectal program	Supported by early-phase (Phase 1/2) data only; confirmatory Phase 3 results pending. Not FDA-approved for these uses

Side Effects to Discuss With Your Oncologist

Daraxonrasib was generally described as "manageable" across trials, but it is not side-effect-free. In RASolute 302, any-grade treatment-related side effects occurred in about 98% of daraxonrasib patients, with grade 3+ (more severe) events in roughly 44% — notably less frequent than with chemotherapy (58%). The most common issues were:

• Skin rash (the single most common severe side effect, around 14% grade 3+)
• Mouth sores / stomatitis (around 12% grade 3+)
• Diarrhea, nausea, and vomiting
• Fatigue, anemia, decreased appetite, and paronychia (nail-fold inflammation)

Only about 1% of daraxonrasib patients discontinued treatment because of side effects, compared with 11% on chemotherapy. Rash and mouth sores were the most common reasons doses were reduced. Some oncologists note that daraxonrasib's rash differs from the rash seen with EGFR-targeted drugs and may benefit from proactive skin-care management — a good topic to raise before starting treatment, not after a problem develops.

Cost and Access

Revolution Medicines set Rasonque's wholesale acquisition cost (list price, before insurance) at $39,800 for a 30-day supply — roughly $477,600 to $484,000 per year, more than double the list price of the world's top-selling cancer drug. That list price is not what most patients actually pay. The company has said commercially insured patients may qualify for as little as a $0 copay through its patient assistance program, and uninsured or underinsured patients who meet income requirements may receive the drug at no cost. The company projects that insurance and government discounts will reduce the effective price by 20–30% versus the list figure.

If cost is a concern, ask your care team or the manufacturer's patient support program (branded "(ON)Path") about copay assistance, foundation grants, and free-drug programs before assuming the list price applies to you.

What This Means for You or a Loved One

• If you have metastatic pancreatic cancer that has progressed after one line of chemotherapy: ask your oncologist whether Rasonque (daraxonrasib) is appropriate for you — it's now an FDA-approved, commercially available option, and testing for a specific RAS mutation isn't required to qualify.
• If you have newly diagnosed metastatic PDAC, or resected PDAC after surgery: daraxonrasib isn't yet approved for these settings, but you may be eligible for RASolute 303 or RASolute 304. Ask your oncology team about trial availability, or search the NCT numbers in this article at ClinicalTrials.gov.
• If you have RAS-mutant non-small cell lung cancer: daraxonrasib, elironrasib, and zoldonrasib remain investigational here. RASolve 301 is enrolling patients whose lung cancer has progressed after immunotherapy and platinum chemotherapy.
• If you have RAS-mutant colorectal cancer: options remain limited to early-phase combination trials at this time; ask your oncologist about eligibility for ongoing studies.
• In every case: treatment decisions should be made with your own oncologist, who knows your full medical history, prior treatments, and other options — this article is educational, not a treatment recommendation.

Using AI Tools to Research Your Options

AI assistants can help you organize questions before an oncology appointment or make sense of dense trial data — but they can also be wrong or out of date, so always verify anything important with your care team. A few ways to use common tools well for this topic:

• Claude / ChatGPT: Paste in your pathology report or a specific trial's eligibility criteria (with personal identifiers removed) and ask, "Which of these eligibility criteria might apply to me, and what questions should I ask my oncologist about them?" Use the answer as a discussion starter, not a diagnosis.
• Gemini: Useful for cross-referencing a drug or trial name against recent news and video explainers (e.g., ASCO presentation recordings) if you want a visual or narrated walkthrough of the data.
• Perplexity: Because it shows inline citations, it can be a fast way to double-check a specific figure (like a survival number or an NCT identifier) against its original source before you rely on it.

Whichever tool you use, bring printed or saved notes to your appointment rather than relying on memory — and treat AI-generated summaries as a starting point for a conversation with your oncologist, not a replacement for one.

Frequently Asked Questions

What does "RASolute" mean?

RASolute is Revolution Medicines' name for its Phase 3 trial program testing daraxonrasib in pancreatic cancer. It's a play on "RAS" (the gene family) and "solute/solution."

Is Rasonque (daraxonrasib) a cure for pancreatic cancer?

No. It significantly extends median survival compared with chemotherapy in previously treated metastatic PDAC, but it is not curative, and most patients in the trial eventually experienced disease progression. It represents a major incremental advance, not a cure.

Do I need genetic testing to qualify for Rasonque?

No. The FDA approval covers patients with metastatic pancreatic adenocarcinoma regardless of RAS mutation status, and doesn't require a companion diagnostic test, because the trial showed benefit in both RAS-mutant and RAS wild-type tumors.

Is daraxonrasib approved for lung or colorectal cancer?

Not as of this writing. It's FDA-approved only for previously treated metastatic pancreatic adenocarcinoma. Lung cancer testing continues in the RASolve 301 trial, and colorectal cancer testing is still in early-phase combination studies.

What are the most common side effects?

Skin rash, mouth sores (stomatitis), diarrhea, nausea, vomiting, fatigue, and anemia were the most frequently reported side effects across trials. Most were manageable, and treatment discontinuation due to side effects was uncommon.

How much does Rasonque cost?

The list price is $39,800 for a 30-day supply (about $477,600 per year), though most patients will pay less depending on insurance coverage and eligibility for the manufacturer's patient assistance programs.

How is RASolute different from RASolve?

RASolute trials (302, 303, 304) test daraxonrasib in pancreatic cancer. RASolve trials (301, 307, 308) test daraxonrasib and related RAS(ON) inhibitors in lung cancer. They come from the same company and drug family but target different cancers.

Sources & References

1. U.S. FDA, "FDA Approves First in Class Targeted Therapy for Metastatic Pancreatic Cancer," August 26, 2026
2. Revolution Medicines press releases and investor presentations, 2025–2026 (ir.revmed.com)
3. Wolpin BM, et al. RASolute 302 Phase 3 results, presented at ASCO 2026 Annual Meeting (Plenary Session) and published in The New England Journal of Medicine, 2026
4. ClinicalTrials.gov: NCT06625320 (RASolute 302), NCT07491445 (RASolute 303), NCT07252232 (RASolute 304), NCT06881784 (RASolve 301), NCT05379985 (Phase 1/2 basis, RMC-6236-001)
5. ASCO patient research summary, "Oral targeted therapy slows pancreatic cancer growth, improves overall survival," asco.org
6. Revolution Medicines, Inc. SEC filings (Forms 8-K and 10-Q), 2026

Medical Disclaimer: This article is for educational purposes only and is not medical advice. It is not a substitute for professional diagnosis or treatment. Drug approval status, trial enrollment, and pricing figures reflect publicly available information as of the publication date and may have changed. Always consult a qualified oncologist about your specific diagnosis, eligibility for treatments or trials, and any decisions about your care.