Joanna Sadowska, Director of Clinical Solutions at Biorce, shared on LinkedIn:
“Big News – BMS’ next-generation radiation therapy succeeds in Phase 3 trial for neuroendocrine tumors
Bristol Myers Squibb has announced positive Phase 3 results for RYZ101, an investigational radiopharmaceutical therapy developed by its subsidiary RayzeBio.
The Phase 3 ACTION-1 trial met its primary endpoint, demonstrating a statistically significant and clinically meaningful improvement in progression-free survival compared with standard-of-care treatment.
RYZ101 uses actinium-225, an alpha-emitting radioisotope, to deliver targeted radiation to cancer cells.
The trial enrolled patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs) whose disease had already progressed following treatment with lutetium-177-based radiopharmaceuticals, which use beta radiation.
This makes the first positive Phase 3 readout for an alpha-emitting targeted radiopharmaceutical therapy.
The detailed efficacy results have not been disclosed yet.
RYZ101 received FDA Orphan Drug Designation in August 2026, and BMS now plans to discuss a regulatory submission.
Hi! I am Joanna, and my friends call me Dr Jojo․
Planning a clinical trial or looking to improve trial design and execution?
DM me – I’d love to connect.”
Other articles about radiation therapy and Bristol Myers Squibb on OncoDaily.
