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RASolute 302

The trial that nearly doubled survival in previously treated pancreatic cancer, presented in the ASCO 2026 plenary. The biggest result in the disease's history.

500 patients, 59 sites. Topline 13 April 2026; presented by Brian Wolpin (Dana-Farber) at the ASCO 2026 plenary (31 May) with simultaneous NEJM publication. Median OS 13.2 vs 6.7 months (HR 0.40, p<0.0001); PFS also significantly improved. NDA submission planned under a Commissioner's National Priority Voucher. First-line (RASolute 303) and adjuvant (RASolute 304) trials follow.

Setting
Metastatic PDAC after one prior line of chemotherapy: daraxonrasib vs investigator's choice chemotherapy
Phase
Phase 3
Sponsor
Revolution Medicines
Registry
Headline result
OS 13.2 vs 6.7 months, HR 0.40.
Reported
2026
Enrolled
460
Replication
Single pivotal trial reported 2026; consistent with the phase 1/2 signal (median OS ~14.5 months in second line). First-line RASolute 303 ongoing.

Outcomes

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In plain words
What these results mean for people, not percentages
460 people took part
Overall survivalprimarysurvival endpoint
  • Median 13.2 vs 6.7 months with Daraxonrasib compared with Chemotherapy (gemcitabine/nab-paclitaxel or mFOLFOX6); about 6.5 months longer for half the group.
  • A median is a midpoint: half the people did better than this and half did worse, so it is not a prediction for any one person.
  • Put another way, the treated group had about 60 percent lower chance of the event at any given time (hazard ratio 0.4).
  • Overall survival counts deaths from any cause, so it is the most direct measure of whether a treatment helps people live longer.
  • These results apply to the people the trial enrolled: Metastatic PDAC after one prior line of chemotherapy: daraxonrasib vs investigator's choice chemotherapy. People in a different situation may not see the same effect.

Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.

460 participants enrolled.

Overall survivalprimary
HR 0.4
Daraxonrasib
13.2 mo
Chemotherapy (gemcitabine/nab-paclitaxel or mFOLFOX6)
6.7 mo
Source
EndpointArmnValueHR (95% CI)pSource
Overall survivalprimaryDaraxonrasib13.2 months0.4link
Chemotherapy (gemcitabine/nab-paclitaxel or mFOLFOX6)6.7 months
Replication
Single pivotal trial reported 2026; consistent with the phase 1/2 signal (median OS ~14.5 months in second line). First-line RASolute 303 ongoing.

Connected

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