BRISTOL MYERS SQUIBB

Biogen and UCB detailed Phase III PHOENYCS GO trial results for dapirolizumab pegol, showing a 49.5% response rate vs. 34.6% with standard care, significant in lupus. DZP hit key secondary endpoints, improved disease activity scores, and corticosteroid tapering, with a well-tolerated side effect profile. A second Phase III trial is planned.

Immunotherapy with nivolumab and ipilimumab shows 30% response rate in anaplastic thyroid carcinoma, a deadly subset with no effective treatments, according to a study in JAMA Oncology.

Merck's subcutaneous Keytruda showed similar characteristics to IV formulation in a Phase 3 trial. The company plans to discuss trial data with FDA and other regulators. Keytruda's U.S. patent expires in 2028, opening the door to biosimilar competitors. Rival Roche has FDA approval for subcutaneous Tecentriq, while Bristol Myers awaits FDA decision on subcutaneous Opdivo. Merck aims to sustain Keytruda's revenue, which reached nearly $22 billion in the first nine months of 2024, by transitioning to a more convenient subcutaneous shot.

Johnson & Johnson's experimental pill, icotrokinra, developed with Protagonist Therapeutics, showed significant skin clearance in 66% of moderate-to-severe plaque psoriasis patients after four months in a Phase 3 trial. The drug aims to match injectable treatments' effectiveness with oral convenience, targeting the IL-23 receptor. While efficacy appears comparable to Stelara and potentially superior to Sotyktu and Otezla, it may not replace Skyrizi and Tremfya due to lower effectiveness. J&J plans to submit approval applications with detailed results from the ICONIC-LEAD and ICONIC-TOTAL studies.

Fanaroff: Research grants from American Heart Association and National Institutes of Health; consulting fees from Abbott Laboratories. Vora: Consulting fees from Medtronic. Mehran: Institutional research grants from AstraZeneca, Bayer, Beth Israel Deaconess, Bristol Myers Squibb/Sanofi, CSL Behring, Eli Lilly/Daiichi Sankyo, Medtronic, Novartis, OrbusNeich; consulting fees from Boston Scientific, Abbott Vascular, Medscape, Siemens Medical Solutions, Roivant Sciences Inc, Sanofi; consulting (no fees) for Regeneron Pharmaceuticals Inc; institutional consulting fees from Abbott Vascular, Spectranetics/Phillips/Volcano Corporation, Bristol Myers Squibb, Novartis, Watermark Research; Executive committee member for Janssen Pharmaceuticals and Bristol Myers Squibb; <1% equity in Claret Medical and Elixir Medical. Granger: Research grants from Bayer, Boehringer Ingelheim, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Armetheon, AstraZeneca, US Food and Drug Administration, GlaxoSmithKline, The Medicines Company, Medtronic Foundation, Medtronic Inc, Novartis; consulting fees from Bayer, Boehringer Ingelheim, Boston Scientific, Bristol Myers Squibb, Daiichi Sankyo, Janssen, Pfizer, Abbvie, Armetheon, AstraZeneca, Eli Lilly, Gilead, GlaxoSmithKline, Hoffmann-La Roche, The Medicines Company, National Institutes of Health, Novartis, Sirtex, Verseon, Apple, Medscape, LLC, Merck, Novo Nordisk, Roche Diagnostics, Rho Pharmaceuticals. Goodman: Research grant support and/or speaker/consulting honoraria from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, CSL Behring, Daiichi-Sankyo, Eli Lilly, Esperion, Fenix Group International, Ferring Pharmaceuticals, GlaxoSmithKline, HLS Therapeutics, Janssen/Johnson & Johnson, Luitpold Pharmaceuticals, Matrizyme, Merck, Novartis, Novo Nordisk A/C, Pfizer, Regeneron, Sanofi, Servier, Tenax Therapeutics, Heart and Stroke Foundation of Ontario/University of Toronto, Canadian Heart Research Centre and MD Primer, Canadian VIGOUR Centre, Duke Clinical Research Institute, PERFUSE. Aronson: Employee of Bristol Myers Squibb. Windecker: Institutional research and educational grants from Abbott, Amgen, Bayer, BMS, CSL Behring, Boston Scientific, Biotronik, Edwards Lifesciences, Medtronic, Polares, Sinomed. Alexander: Research grants from Bristol Myers Squibb, Boehringer Ingelheim, AstraZeneca, CryoLife, CSL Behring, US Food and Drug Administration, National Institutes of Health, Sanofi, VoluMetrix; consulting fees from Pfizer, Bristol Myers Squibb, AbbVie Pharmaceuticals, CSL Behring, Novo Nordisk, Portola Pharmaceuticals, Quantum Genomics, Teikoku Pharmaceuticals, VA Cooperative Studies, Zafgen. Lopes: Research grants from Bristol Myers Squibb, Pfizer, Amgen, Inc, GlaxoSmithKline, Medtronic PLC, Sanofi Aventis; consulting fees from Bristol Myers Squibb, Pfizer, Boehringer Ingelheim, Bayer AG. The other authors report no conflicts.

Johnson & Johnson's once-daily oral IL-23 inhibitor icotrokinra met efficacy objectives in phase 3 ICONIC-LEAD trial for moderate to severe plaque psoriasis, with 74.1% achieving clear or almost clear skin at week 24. The drug showed similar safety profiles to placebo and could offer a patient-friendly alternative to injectable biologics. J&J plans to submit data to regulators and compete with Bristol-Myers Squibb's TYK2 inhibitor Sotyktu.

SEC recommended approval of Bristol-Myers Squibb's nivolumab for first-line treatment of unresectable or metastatic urothelial carcinoma with cisplatin and gemcitabine, waiving local phase III trial. The company must conduct a phase IV trial in India.

Nouscom completes enrollment of 69 patients in Phase 2 trial evaluating NOUS-209 with pembrolizumab in MSI mCRC. Primary efficacy endpoint readout expected in mid-2025.

Companies are adopting inclusive business models to reach low-income countries, but outcomes are mixed with unclear patient reach. R&D focus is insufficient, especially in low-income countries, risking exclusion of diverse populations and limited product access. Voluntary licensing and technology transfers are crucial for sustainable access, yet activities have slowed, with limited efforts in sub-Saharan Africa.

Bristol Myers Squibb announced CHMP's recommendation for Opdivo plus Yervoy approval for first-line treatment of MSI-H/dMMR unresectable or metastatic colorectal cancer, based on CheckMate -8HW trial results showing a 79% reduction in disease progression or death risk compared to chemotherapy. The EC will review the recommendation.