Bristol Myers Squibb has resumed recruitment for its lead radiopharmaceutical trial after an isotope shortage forced a pause earlier this year, chief medical officer Samit Hirawat said on the company’s second-quarter earnings call.
While the large pharma has resumed the Phase 3 study from its $4.1 billion RayzeBio buyout, it has now delayed the Phase 3 trial’s readout from 2025 to 2026, according to a quarterly update on Friday morning.
Samit HirawatThe Phase 3 trial has been closely watched by those in the radiopharma space: It’s the actinium-225-based medicine that’s the furthest along in development. Large drugmakers have been betting billions of dollars on new radiopharma startups in recent quarters, forging multiple partnerships and acquisitions. Behind BMS in the actinium race are Novartis, Eli Lilly, AstraZeneca and Johnson & Johnson. Smaller biotechs like Abdera are entering the field as well.
Bristol Myers’ actinium-225-based radiopharmaceutical agent RYZ101 is being tested in patients with certain forms of gastroenteropancreatic neuroendocrine tumors, or GEP-NETs. Novartis’ lutetium-based radioligand therapy Lutathera is approved for certain forms of the rare tumor.
Endpoints News first reported on the trial recruitment pause early in June. At the time, BMS said it planned to resume new patient enrollment in the third quarter. The study includes sites in the US, Brazil, Belgium, Canada, France, the Netherlands and Spain.
The trial should complete enrollment “as expected in 2025 and read out in 2026,” a BMS spokesperson told Endpoints via email on Friday afternoon.
“It’s widely known that high quality actinium supply which meets our standards has been limited,” the spokesperson said. “We’ve identified the source of the supply issue and it has been resolved.”
Shares of Bristol Myers $BMY were up more than 9% on Friday afternoon thanks to an overall outperformance across its portfolio.
No actinium-based radiopharmaceutical treatments have been approved by the FDA, meaning Bristol Myers could be the front-runner in a new class. The first indication from the RayzeBio takeover is not likely to be BMS’ biggest splash in the radiopharmaceutical space, but it could set the tone for expansions into other tumor types.
Adam Lenkowsky“The lead program, ‘101 in GEP-NET, is a fairly modest commercial opportunity,” BMS chief commercialization officer Adam Lenkowsky said on the earnings call. “However, when you look at this technology, particularly [the] actinium-based radiopharmaceutical platform, this has the potential to have efficacy and safety across a host of solid tumor treatments. We are looking at this in small cell lung cancer and potentially many other tumor types.”
A Phase 1b trial of RYZ101 in patients with certain forms of small cell lung cancer continued recruiting during the isotope shortage. The company anticipates dose-finding data in 2025, a spokesperson said.
The company is setting up a GMP manufacturing facility in Indiana that could help shore up future supplies of actinium-225 isotope, BMS has said, but it currently relies on third parties for the critical treatment component.
“We are rapidly advancing toward on-site production of Ac225 and anticipate the ability to supplement ongoing clinical supply through internal production in Q1 2025,” the spokesperson said.
The Russia-Ukraine war has previously caused a “slight delay” in securing Ac225, but the issue had been resolved, RayzeBio had warned in its few months as a public company last fall.
“We believe this is a really exciting platform, one that’s going to grow significantly through the back end of the decade,” Lenkowsky said on the analyst call. “And what particularly excites us about Rayze is the robust IND engine that we’ll see over the course of the next decade-plus, as well as what we know is state-of-the-art manufacturing facilities ahead.”
Lei Lei Wu contributed reporting.