Practice-entering research
RASolute 302 — daraxonrasib vs standard care in metastatic PDAC (phase III)
RASolute 302: A Phase 3 Multicenter, Open-label, Randomized Study of Daraxonrasib (RMC-6236) Versus Investigator's Choice of Standard of Care Therapy in Patients With Previously Treated Metastatic Pancreatic Ductal Adenocarcinoma (PDAC)
- Phase
- Phase III
- Recruitment
- Completed
- Results maturity
- Primary analysis
- Publication
- Peer-reviewed
- Regulatory approval
- FDA approval — 26 August 2026 (US)
- NCT
- NCT06625320
- Registry checked
- 2026-10-29
- Editorial update
- 2026-10-31
Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.
For patients
What is being studied? An oral RAS-targeted drug prolonged survival versus standard chemotherapy in advanced pancreatic cancer. It is FDA-approved; access may differ by country.
Why promising? In previously treated metastatic PDAC, oral daraxonrasib prolonged overall and progression-free survival versus investigator-choice chemotherapy and is FDA-approved in the US.
What is not proven? Türkiye/EMA license and reimbursement are separate. Do not generalize to resectable disease or first-line use. Open-label design needs longer follow-up.
Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.
For clinicians
n=500 (248/252). ITT OS 13.2 vs 6.7 mo (HR 0.40); ITT PFS 7.2 vs 3.6 mo (HR 0.49); ITT ORR 31.6% vs 11.2%. Primary RAS G12: OS 13.2 vs 6.6 mo (HR 0.40); PFS 7.3 vs 3.5 mo (HR 0.45). FDA 26 Aug 2026. Align with Landmark Atlas `rasolute-302`; Ufuk does not award stars.
Cancer / population: Pancreas — Önceden bir hat tedavi almış metastatik PDAC
Intervention: Daraxonrasib (RMC-6236)
Primary endpoint: RAS G12 popülasyonunda OS ve PFS (çift primer)
Source-verified summary: Pankreas Landmark `rasolute-302` ile hizalı: ITT OS 13,2 vs 6,7 ay (HR 0,40); PFS 7,2 vs 3,6 ay (HR 0,49); ORR %31,6 vs %11,2. FDA 26 Ağu 2026 (ABD).
Limitations: Açık etiketli; 2. basamak popülasyon. Türkiye ruhsat/erişim ayrı. Erken faz RMC-6236-001 ORR’ı doğrudan taşınmaz.
Landmark Atlas links
Cross-links are informational only; this module does not award or change gold stars.