The data de-risk two Phase 3 strategies in a large, RAS G12D PDAC market (~40% of pancreatic cancer cases) with no approved targeted therapy. Monitor enrollment and interim updates for RASolute 305 and initiation of RASolute 309. The 82% ORR in first-line with mFFX is best-in-class potential, but final Phase 3 OS data are needed for approval. Hold / accumulate on further de-risking.
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Executive Summary
Revolution Medicines reported positive Phase 1/2 data for zoldonrasib in RAS G12D metastatic pancreatic cancer at ESMO GI 2026. In previously untreated patients, zoldonrasib plus chemotherapy showed an 82% objective response rate (ORR) with mFFX and a 61% ORR with GnP. In previously treated patients, the zoldonrasib plus daraxonrasib doublet achieved a 50% ORR and 9.6-month median progression-free survival in second-line, supporting two Phase 3 trials (RASolute 305 ongoing, RASolute 309 planned).
Key Facts
- Zoldonrasib plus mFFX in first-line metastatic RAS G12D PDAC: 82% ORR, 96% DCR (n=41).
- Zoldonrasib plus GnP in first-line: 61% ORR, 90% DCR (n=40).
- Zoldonrasib plus daraxonrasib in second-line: 50% ORR, 97% DCR, median PFS 9.6 months (n=30).
- Third-line-plus doublet: 47% ORR, 90% DCR, median OS 10.5 months (n=30).
- Safety manageable with no Grade 5 TRAEs; discontinuation due to TRAEs low (2-5%).
- Data support planned Phase 3 RASolute 309 trial of zoldonrasib plus daraxonrasib vs GnP in first-line.
- RAS G12D is the most prevalent RAS mutation subtype in PDAC (40% of patients), with ~61,000 new US cases/year across all cancers.
Financial Impact
Positive Phase 1/2 data for zoldonrasib-based regimens in RAS G12D pancreatic cancer; supports pivotal Phase 3 trials and expands target market beyond the prior daraxonrasib monotherapy. No revenue or financial guidance provided.
Risk Factors
- Phase 3 trials (RASolute 305, 309) may fail to replicate Phase 1/2 efficacy or show OS benefit.
- Safety profile with combination regimens may limit the tolerability in broader patient population.
- Competing RAS-targeted therapies (e.g., from Amgen, Mirati/BMS) could enter the same indication.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3321282 |
Filters
| Type | Now | ||||
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Sep 15, 2026 16d ago | 144 | $195.92 $190.74 | ▼ −2.64% | ▼ −5.21% | $206.64 (+5.47%) |
Sep 15, 2026 16d ago | 144 | $195.92 $190.74 | ▼ −2.64% | ▼ −5.21% | $206.64 (+5.47%) |
Sep 15, 2026 17d ago | Insider Cluster | $204.86 $190.95 | ▼ −6.79% | ▼ −7.61% | $206.64 (+0.87%) |
Sep 14, 2026 17d ago | Insider Cluster | $204.86 $192.86 | ▼ −5.86% | ▼ −7.98% | $206.64 (+0.87%) |
Aug 26, 2026 5w ago | 8-K | $215.44 $209.23 | ▼ −2.88% | ▼ −2.76% | $206.64 (−4.08%) |
Aug 26, 2026 5w ago | Press Release | $215.44 $209.23 | ▼ −2.88% | ▼ −2.76% | $206.64 (−4.08%) |
Aug 25, 2026 5w ago | Insider Cluster | $211.38 $209.87 | ▼ −0.71% | ▼ −0.18% | $206.64 (−2.24%) |
Jul 2, 2026 13w ago | Press Release | $189.24 $191.13 | ▲ +1.00% | ▲ +0.07% | $206.64 (+9.19%) |
Jul 1, 2026 13w ago | Insider Cluster | $187.51 $190.46 | ▲ +1.57% | ▲ +1.31% | $206.64 (+10.20%) |
Jun 22, 2026 14w ago | 8-K | $165.81 $192.62 | ▲ +16.17% | ▲ +16.62% | $206.64 (+24.62%) |
US Market Status
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