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Jul 2, 2026Weekly roundup

BMS posts PRIME-HCC results; adds SOTYKTU label update, Phase 3 lung trial

Bristol-Myers Squibb's week included a labeling supplement for SOTYKTU, posted results from an Imperial College-sponsored HCC trial, a new Phase 3 lung cancer registration, and two observational studies.

Bristol-Myers Squibb appeared across five clinical and regulatory updates this week, spanning a label change, posted trial results, a new pivotal study, and observational research.

  • The FDA approved a labeling supplement for SOTYKTU (deucravacitinib), a 6MG oral tablet sponsored by Bristol.1 The submission was recorded as submission class Labeling, submission number 61, with a submission status date of 2026-06-30.1
  • The PRIME-HCC trial, sponsored by Imperial College London with BMS as collaborator, completed and posted results. The trial assessed combination treatment with nivolumab (OPDIVO) and ipilimumab (YERVOY) pre-operatively in hepatocellular carcinoma patients for whom liver resection is planned,2 conducted at a small number of National Health Service hospitals in the UK.2 Actual enrollment reached 33 participants.2
  • BMS registered "IZABRIGHT-Lung02," a Phase 3 trial. The study will evaluate izalontamab brengitecan (iza-bren) combined with osimertinib in participants with previously untreated, locally advanced or metastatic EGFR-mutant NSCLC, compared to osimertinib alone or osimertinib combined with platinum-based chemotherapy.3 The trial is not yet recruiting3, with an estimated enrollment of 850 participants3 and an estimated start date of 2026-09-30.3
  • A new observational study, "J-PROMISE," is recruiting in Japan, sponsored by BMS with Ono Pharmaceutical Co., Ltd.4 as collaborator. The study looks at how a combination of nivolumab and ipilimumab is used to treat people with advanced liver cancer that cannot be removed by surgery, following adults receiving this treatment in routine medical care in Japan to understand safety, efficacy, and usage patterns.4 Estimated enrollment is 200 participants.4
  • A BMS-sponsored real-world study of luspatercept in lower-risk myelodysplastic syndromes and beta-thalassemia was terminated. The study was designed to understand the patient profile, utilized treatments, treatment patterns, resulting outcomes, and associated costs relating to luspatercept treatment in patients with lower-risk myelodysplastic syndromes (LR-MDS) or beta-thalassemia in the real-world setting.5 Overall status was recorded as terminated (why stopped: Insufficient enrollment)5, reaching actual enrollment of 30 participants5, with primary completion recorded as 2025-05-01.5

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.