Bristol Myers Squibb reported that two investigational treatments met primary endpoints in separate Phase 3 studies, with RYZ101 improving progression-free survival in neuroendocrine tumors and admilparant showing a lung-function benefit at its lower tested dose in idiopathic pulmonary fibrosis.
A planned interim analysis of ACTION-1 found a statistically significant improvement in progression-free survival with RYZ101 compared with investigator-selected standard care, as assessed by blinded independent central review. Safety findings were consistent with the treatment’s known profile, the company said.
The randomized trial enrolled patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors whose disease had progressed after lutetium-177-based therapy. Comparator options included high-dose or high-frequency long-acting somatostatin analogues, everolimus or sunitinib.
RYZ101, developed by BMS subsidiary RayzeBio, links DOTATATE to actinium-225, an alpha-emitting radioisotope designed to deliver radiation to targeted cancer cells. BMS described ACTION-1 as providing the first Phase 3 results for an alpha-isotope-based targeted radiopharmaceutical therapy.
Participants will continue receiving care under the study protocol and will be followed for overall survival. RayzeBio plans to discuss next steps toward a regulatory submission with the FDA, which granted RYZ101 orphan drug designation in August 2026.
Separately, ALOFT-IPF met its primary endpoint with admilparant at 60 milligrams twice daily, demonstrating a statistically significant benefit versus placebo in absolute change in forced vital capacity from baseline to week 52. The 120-milligram dose slowed lung-function decline but did not achieve statistical significance.
The randomized, double-blind trial enrolled approximately 1,255 adults aged 40 and older with idiopathic pulmonary fibrosis. Both doses had low rates of discontinuation due to adverse events, similar to placebo, according to BMS.
Admilparant is an oral lysophosphatidic acid receptor 1 antagonist. It is also being evaluated in the fully enrolled Phase 3 ALOFT-PPF trial for progressive pulmonary fibrosis, with topline results expected in early 2027.
BMS plans to present detailed results from both studies at future medical meetings. For admilparant, the company will complete a comprehensive evaluation of ALOFT-IPF data and engage health authorities to support planned regulatory submissions. Both RYZ101 and admilparant remain investigational treatments in their respective development programs, rather than approved therapies for the indications studied.
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