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
BMS said the interim ACTION-1 analysis met its primary progression-free-survival endpoint in previously treated GEP-NETs.
TL;DR
- Bristol Myers Squibb reported positive topline interim results from the Phase 3 ACTION-1 trial of RYZ101 in GEP-NETs.
- The company said the study met its primary endpoint of progression-free survival by blinded independent central review.
- Full numerical results and detailed safety data were not included in the topline announcement.
Bristol Myers Squibb announced on October 12 that an interim analysis of ACTION-1 met its primary endpoint, reporting a statistically significant and clinically meaningful improvement in progression-free survival for RYZ101 compared with investigator’s choice of standard care. [1] [2]
ACTION-1 is a randomized Phase 3 study of RYZ101, also known as 225Ac-DOTATATE, in people with somatostatin-receptor-positive gastroenteropancreatic neuroendocrine tumors whose disease progressed after lutetium-177-based therapy. The comparator options listed by the company include somatostatin analogues, everolimus, or sunitinib. [1] [2]
The announcement says the endpoint was assessed by blinded independent central review and that the safety findings were consistent with the known profile. It is a topline corporate report; the release does not provide the full effect size, confidence intervals, or a peer-reviewed account. [1] [2]
BMS said the trial would continue and that further details would be presented at a future medical meeting. The magnitude and durability of benefit, and how regulators may assess the data, remain open pending fuller results. [1] [2]
Why it matters
An interim Phase 3 endpoint result can change the development outlook for a radiopharmaceutical candidate, but the topline disclosure leaves important clinical detail for later presentation.
Editor's note
Headlines and numerical claims follow the BMS announcement. BioBriefs coverage is secondary reporting; the full dataset is not yet available in the cited release.