1.Roche announced that its investigational BTK inhibitor fenebrutinib met the primary endpoints in two pivotal Phase III studies
Roche announced that its investigational BTK inhibitor fenebrutinib met the primary endpoints in two pivotal Phase III studies: FENhance 2 (for relapsing multiple sclerosis [RMS]) showed a significant reduction in annualized relapse rate (ARR) vs. teriflunomide over at least 96 weeks; FENtrepid (for primary progressive multiple sclerosis [PPMS]) demonstrated non-inferiority to ocrelizumab (the only approved PPMS therapy) in delaying confirmed disability progression over at least 120 weeks, with numerical benefits observed as early as Week 24 and sustained throughout the study period. Results from the second RMS study (FENhance 1) are expected in H1 2026, with combined data to be submitted for regulatory review.
Link:https://www.roche.com/media/releases/med-cor-2025-11-10
2.Positive phase III data for Gazyva/Gazyvaro show significant reduction in disease activity for systemic lupus erythematosus
Roche announced positive results from the Phase III ALLEGORY study of Gazyva®/Gazyvaro® (obinutuzumab), a CD20 monoclonal antibody, in adults with systemic lupus erythematosus (SLE) on standard therapy. The randomized, double-blind, placebo-controlled trial (n≈300, 1:1 randomization) met its primary endpoint at 52 weeks, with a significantly higher proportion of patients in the obinutuzumab group achieving a ≥4-point improvement in the SLE Responder Index 4 (SRI-4) versus standard therapy. All key secondary endpoints were also met, including BICLA response, sustained corticosteroid control, sustained SRI-4 response, SRI-6 improvement, and prolonged time to first disease flare at Week 52. No new safety signals emerged, with the safety profile consistent with obinutuzumab’s established characteristics.
Link:https://www.roche.com/media/releases/med-cor-2025-11-03
3.DARZALEX FASPRO is the first and only treatment approved by FDA for patients with high-risk smoldering multiple myeloma
Johnson & Johnson announced the U.S. FDA approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) as monotherapy for adults with high-risk smoldering multiple myeloma (HR-SMM) — the first and only FDA-approved treatment for HR-SMM enabling early intervention before progression to active myeloma. Approved based on results from the Phase III AQUILA study (the largest Phase III trial in HR-SMM), the agent significantly improved progression-free survival (PFS) versus active monitoring, reducing the risk of disease progression or death by 51% per IMWG criteria (HR=0.49, 95%CI: 0.36-0.67, p<0.0001). The recommended dose is 1,800mg/30,000 units administered subcutaneously, with a safety profile including warnings for hypersensitivity and cardiac toxicity, and no new safety signals identified.
4.FDA approval of CAPLYTA (lumateperone) has the potential to reset treatment expectations, offering hope for remission in adults with major depressive disorder
Johnson & Johnson announced that the U.S. FDA has approved CAPLYTA® (lumateperone) as an adjunctive therapy to antidepressants for treating adults with major depressive disorder (MDD). This marks the first FDA approval led by Johnson & Johnson following its acquisition of Intra - Cellular Therapies, Inc., and the fourth approved indication for CAPLYTA. As the only FDA - approved agent for treating depressive episodes in adults with bipolar I and II disorders (both as monotherapy and adjunctive therapy), it was previously approved for treating adult schizophrenia. Notably, CAPLYTA requires no titration for easy initiation and maintenance of treatment, with metabolic side effects like weight gain similar to those of the placebo. Its approval was backed by two pivotal Phase III studies, showing efficacy as early as 1 to 2 weeks and significant improvement in depression scores at week 6.
5.Dupixent pivotal study met all primary and secondary endpoints, reducing signs and symptoms of allergic fungal rhinosinusitis
Sanofi and Regeneron announced that their jointly developed Dupixent (dupilumab) achieved all primary and secondary endpoints in the phase 3 LIBERTY - AFRS - AIMS study for allergic fungal rhinosinusitis (AFRS). The study enrolled 62 AFRS patients aged 6 years and above, with 33 receiving Dupixent (200mg or 300mg every 2 or 4 weeks based on age and weight) and 29 given a placebo. At weeks 24 and 52, the Dupixent group showed a significant improvement in the primary endpoint of sinus opacification score and secondary endpoints including patient - reported nasal congestion and nasal polyp size compared with the placebo group, with statistically significant differences (p<0.0001). By week 52, the Dupixent group saw a 50.0% improvement in sinus opacification, an 80.6% improvement in nasal congestion and a 62.5% reduction in nasal polyp size, versus only 9.8%, 11.1% and 3.6% in the placebo group. Moreover, the Dupixent group had a 92% lower risk of requiring systemic corticosteroids and/or surgery over 52 weeks (p=0.0010).
Link：https://www.sanofi.com/en/media-room/press-releases/2025/2025-11-07-13-00-00-3183599
6.eloralintide demonstrated meaningful weight loss and favorable tolerability in a Phase 2 study of adults with obesity or overweight
Eli Lilly and Company (NYSE: LLY) today announced positive results from a Phase 2 trial evaluating the safety and efficacy of eloralintide, an investigational once-weekly, selective amylin receptor agonist, in 263 adults with obesity or overweight with at least one obesity-related comorbidity and without type 2 diabetes. At 48 weeks, all treatment arms of eloralintide met the primary endpoint, demonstrating superior mean weight reductions from 9.5% to 20.1% compared to 0.4% with placebo using the efficacy estimand.1 Results from the trial were presented at ObesityWeek 2025 and simultaneously published in The Lancet.
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