BMS reports Phase 3 success for RYZ101 in GEP-NET trial

Bristol Myers Squibb said its radiopharmaceutical candidate RYZ101 met the primary endpoint in a late‑stage Phase 3 study. The drug was acquired in BMS's $4.1 billion purchase of RayzeBio, completed in early 2024.

The trial, called ACTION‑1, enrolled patients with advanced somatostatin‑receptor‑expressing gastroenteropancreatic neuroendocrine tumors (GEP‑NETs) who had progressed after receiving Novartis' Lutathera, the current standard of care. An interim analysis showed a statistically significant and clinically meaningful improvement in progression‑free survival, as judged by blinded independent central review.

BMS did not release the exact efficacy numbers. The primary endpoint was set to be evaluated after 143 progression‑free survival events, according to ClinicalTrials.gov. The positive readout highlights the potential of actinium‑225‑based radiopharmaceuticals in treating this rare cancer type.