BMS posts JAKARTA Phase 3 results, updates Opdivo label, registers golcadomide renal study

Bristol-Myers Squibb had four notable regulatory and clinical trial updates this week.

• Results were posted for "JAKARTA," a terminated Phase 3, randomized, double-blind, placebo-controlled trial of SAR302503 in patients with intermediate-2 or high-risk myelofibrosis. The trial aimed to evaluate the efficacy of daily oral doses of 400 mg or 500 mg of SAR302503 compared to placebo in reducing spleen volume as determined by MRI or CT imaging.¹ The study enrolled 289 participants¹ and results were first posted August 11, 2026.
• OPDIVO (nivolumab) received a labeling supplement approval. The FDA approved a labeling submission for OPDIVO (BLA125554, SUPPL 138), covering the injectable 40mg/4ml nivolumab product, under standard review priority, with a submission status date of August 12, 2026.²
• A new Phase 1 pharmacokinetics study of golcadomide (BMS-986369) was registered. The trial will compare drug exposure and safety in matched groups: healthy volunteers with normal kidney function, adults with severe renal impairment, and those with end-stage renal disease. The study is not yet recruiting, with an estimated start date of August 24, 2026, and³ an estimated enrollment of 30 participants.³
• A post-marketing surveillance study of repotrectinib in pediatric patients in Japan is recruiting. The observational study will track how often side effects occur, with particular focus on central nervous system disorders, interstitial lung disease, and fractures⁴ in children and adolescents with NTRK fusion-positive advanced or recurrent solid tumors starting repotrectinib. Estimated enrollment is 20 participants.⁴