Primary-source record
Decision-gradeTopline results
BMY Announces Positive Phase 3 ACTION-1 Topline for RYZ101 in GEP-NETs
The Phase 3 ACTION-1 trial of RYZ101 (225Ac-DOTATATE) versus investigator's choice of standard of care met its primary endpoint of statistically significant and clinically meaningful improvement in progression-free survival by blinded independent central review in patients with SSTR+ GEP-NETs who progressed after Lu177-based therapy. Safety was consistent with the known profile. This is the first Phase 3 data for an alpha-isotope (225Ac) targeted radiopharmaceutical therapy; RayzeBio plans to engage FDA on next steps toward submission.
Key facts
- Filed
- Oct 12, 2026, 10:55 AM
- Event
- Topline results
- Direction
- Positive
- Company
BMYBristol-Myers Squibb- Asset
- RYZ101
- Source
- Company press release
- Confidence
- Sourced
- PFS
- statistically significant and clinically meaningful improvement
Source excerpt
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 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 Announces Positive Topline Results from the Interim Analysis of Phase 3 ACTION-1 for RYZ101, RayzeBio’s Radiopharmaceutical Therapy, in Patients with GEP-NETs The study met the primary endpoint with a statistically significant and clinically meaningful improvement in progression free survival (PFS) Bristol Myers Squibb (NYSE: BMY) today announced positive topline results from the planned interim analysis of the ACTION-1 trial (NCT05477576) conducted by RayzeBio, Inc. , a Bristol Myers Squibb company. The study met the primary endpoint with a statistically significant and clinically meaningful improvement in progression-free survival by blinded independent central review, and safety results consistent with the known RYZ101 safety profile. ACTION-1 is a randomized Phase 3 clinical trial evaluating RYZ101 ( 225 Ac-DOTATATE) versus investigator's choice of standard of care (high-dose or high-frequency long-acting somatostatin analogues, everolimus, or sunitinib) in patients with somatostatin receptor-positive (SSTR+) gastroenteropancreatic neuroendocrine tumors (GEP-NETs) who have progressed follo