BRISTOL MYERS SQUIBB

The European Commission approved Opdivo plus Yervoy for first-line treatment of MSI-H or dMMR metastatic colorectal cancer, offering a new option for patients with poor prognosis. This decision, based on the CheckMate -8HW trial, highlights significant progress in cancer treatment across the EU.

Deucravacitinib (Sotyktu) outperformed placebo in achieving ACR20 response in psoriatic arthritis patients after 16 weeks, meeting primary endpoints in 2 pivotal phase 3 trials. The trials also met secondary endpoints for PsA disease activity and maintained a consistent safety profile. Deucravacitinib, currently FDA-approved for moderate-to-severe plaque psoriasis, showed durable clinical response and consistent safety through 3 years.

Bristol Myers Squibb announced positive outcomes from 2 phase 3 trials, POETYK PsA-1 and POETYK PsA-2, evaluating deucravacitinib's efficacy and safety in active PsA. Both trials met primary and secondary endpoints, showing significant ACR20 response improvements by week 16. Deucravacitinib, an oral TYK2 inhibitor, offers a novel treatment option with a favorable safety profile, potentially addressing unmet needs in PsA treatment.

XBiotech halts rheumatology studies after Natrunix Phase II trial fails, citing irregularities. Stock drops 27%. Follow-up studies on arthritis and ankylosing spondylitis postponed indefinitely.

2024 saw significant medical breakthroughs, including gene therapy restoring hearing in children with hereditary deafness, the first genetically-edited pig kidney transplant into a human, discovery of a cause of lupus and potential reversal, FDA approval of the first new class of schizophrenia drug in over 30 years, and authorization of the first over-the-counter combo flu and COVID-19 test outside of emergency use.

The global antidepressants drugs market is projected to grow from US$ 13.8 billion in 2023 to US$ 30.5 billion by 2033, driven by rising mental health disorders, increased awareness, and advancements in treatment options. North America led in 2023 with a 35.3% share. Challenges include side effects and variability in drug efficacy. Recent advancements include new antidepressants with fewer side effects and ongoing research into innovative treatments.

Nivolumab plus ipilimumab approved by EC for frontline treatment of MSI-H/dMMR mCRC, based on CheckMate -8HW trial showing improved PFS compared to chemotherapy. The combination demonstrated a favorable safety profile and significant clinical benefit for this patient population.

Bristol Myers Squibb received European Commission approval for Opdivo and Yervoy as a first-line treatment for certain colorectal cancers, based on Phase 3 CheckMate -8HW trial results showing a 79% reduction in disease progression risk. The approval benefits patients with MSI-H/dMMR metastatic colorectal cancer, marking a significant advancement in treatment options.

Biomarker-driven treatment for muscle-invasive bladder cancer showed a 2-year metastasis-free survival rate of over 70% in a phase II study, but missed statistical targets. Active surveillance based on tumor genomics achieved a 2-year MFS of 76%. Despite missing statistical boundaries, the approach shows promise for bladder preservation.