Bristol Myers Squibb Announces Positive Topline Results from the Interim Analysis of Phase 3 ACTION-1 for RYZ101, RayzeBio’s Radiopharmaceutical Therapy, in Patients with GEP-NETs
Bristol Myers Squibb announced positive topline results from the interim analysis of the Phase 3 ACTION-1 trial for RYZ101, the radiopharmaceutical therapy developed by its subsidiary RayzeBio. The study met its primary endpoint with a statistically significant, clinically meaningful improvement in progression-free survival in patients with somatostatin receptor-positive GEP-NETs who progressed after Lu177-based therapy, with safety consistent with the known profile.
Key figures
- Drug Name
- RYZ101 ((225)Ac-DOTATATE)
- Phase Of Trial
- Phase 3
- Trial
- ACTION-1 (NCT05477576)
- Endpoint
- progression-free survival (PFS) by blinded independent central review
- Orphan designation
- FDA Orphan Drug Designation for GEP-NETs granted August 2026
- Gep net incidence us
- ~18,000 patients annually
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