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Median overall survival — RASolute 302 (G12-mutant)

Hazard ratio for death 0.40 (95% CI 0.31–0.52), P<0.001. Source: NEJM, NCT06625320.

Tuesday, 2 June 2026

Daraxonrasib roughly doubles survival over chemotherapy in previously treated metastatic pancreatic cancer

In the Phase 3 RASolute 302 trial, the investigational oral RAS inhibitor from Revolution Medicines cut the risk of death by 60 percent versus investigator's-choice chemotherapy.

Sofia Mendes, Biotech Business & Markets Desk · 3 min read

Metastatic pancreatic cancer that has already progressed on one line of treatment is among the bleakest settings in oncology: second-line chemotherapy typically extends median survival by only a few months. A peer-reviewed Phase 3 trial published in the New England Journal of Medicine now reports that daraxonrasib (RMC-6236), an investigational oral RAS inhibitor from Revolution Medicines, roughly doubled median overall survival against chemotherapy in this population.

In RASolute 302, an international, open-label, randomized trial, 500 patients with previously treated metastatic pancreatic ductal adenocarcinoma (mPDAC) were assigned to daraxonrasib (248 patients) or chemotherapy of the investigator’s choice (252 patients). Of those enrolled, 91.8 percent carried RAS G12 mutations. Daraxonrasib is an oral RAS(ON) multiselective, tri-complex inhibitor that targets the active, GTP-bound state of both mutant and wild-type RAS — the pathway aberrantly activated in more than 90 percent of pancreatic ductal adenocarcinoma cases.

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Trials Today

Phase 3 VECTRA-01 (AZD2265 / 225Ac-PSMA-I&T, mCRPC) — Recruiting; alpha-emitter PSMA radioligand vs SOC after prior beta-emitter, taxane and ARPI; ~670 patients; dual primary rPFS and OS.
Phase 3 PRECISE-HD (pridopidine, Huntington's disease) — Newly registered; 400 patients not on antidopaminergics; primary is 52-week change in composite cUHDRS.
Phase 3 QUILT-2.023 (nogapendekin alfa inbakicept, 1L NSCLC) — Terminated; sponsor registry note states no active subjects, no efficacy results posted (enrolled 102).
Phase 3 Atezolizumab + standard HER2 therapy, 1L HER2+ mBC (NRG/NCI) — Terminated for poor accrual (190 enrolled); posted PFS 52.3% vs 40.5% is a numerical, underpowered signal only (CIs overlap, no HR).
Phase 2/3 Peri-operative nivolumab + ipilimumab, esophageal/GEJ adenocarcinoma (NCI) — Suspended after enrolling 278; registry summary gives no reason, so cause is unconfirmed. Watch item.

At the Agencies

Baxdrostat (Baxfendy), AstraZeneca — FDA approval May 18, 2026; first-in-class aldosterone synthase inhibitor for uncontrolled/resistant hypertension; BaxHTN placebo-adjusted SBP -9.8 mmHg.
Bulevirtide (Hepcludex), Gilead — FDA accelerated approval May 22, 2026; first US therapy for chronic hepatitis delta; surrogate week-48 combined response 48% vs 2%, confirmatory data required.
Pivekimab sunirine (Decnupaz), AbbVie — FDA approval May 27, 2026; first CD123-directed ADC for ultra-rare BPDCN; single-arm CADENZA CR/CRc 69.7% in treatment-naive (n=33).
Nerandomilast (Jascayd), Boehringer Ingelheim — EMA CHMP — Positive CHMP opinion (18-21 May 2026) for IPF and PPF; oral PDE4B inhibitor; FIBRONEER-IPF met primary FVC endpoint, key secondary not met. EC decision pending.

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Biotech Business

Daraxonrasib roughly doubles survival over chemotherapy in previously treated metastatic pancreatic cancer

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