Innovative Medicine

Biweekly dosing with TECVAYLI®, the first approved BCMA-targeting bispecific antibody, provides patients with dosing flexibility

Presentations include additional analyses of nipocalimab data from pregnancies at risk for early-onset severe HDFN; Nipocalimab is the only anti-FcRn being studied in this rare and potentially life-threatening two-person disease for which there are no approved non-surgical therapies

Breakthrough Therapy Designation for nipocalimab based on results from the Phase 2 UNITY clinical trial for HDFN Phase 3 clinical trial enrollment underway, representing the only therapy reported to be under clinical development for this serious, life-threatening and rare condition

The submission is supported by data from the Phase 3 MARIPOSA study, showing statistically significant and clinically meaningful improvement in progression-free survival in patients with EGFR-mutated advanced NSCLC treated with amivantamab plus lazertinib versus osimertinib1 Amivantamab is a fully-human EGFR-MET bispecific antibody with immune cell-directing activity that targets tumours with activating and resistance EGFR mutations and MET mutations and amplifications2,3,4,5

Data from FRONTIER 1, a Phase 2b clinical trial, show JNJ-2113, the first and only targeted oral peptide that selectively blocks the IL-23 receptor, achieved the primary and all secondary endpoints including PASIa 100 and IGAb 0 responses of 40.5 percent and 45.2 percent, respectively

Nipocalimab showed clinical efficacy in gMG, a chronic debilitating autoantibody disease where significant unmet patient need exists for efficacious, safe therapies that offer sustained disease control Nipocalimab is the first investigational anti-FcRn to show efficacy in SjD, one of the most prevalent, debilitating autoantibody diseases that has no approved advanced treatments In the past 12 months, nipocalimab has demonstrated clinical effect in four different autoantibody-driven diseases

Data supporting the application showed the addition of DARZALEX FASPRO® to lenalidomide, bortezomib and dexamethasone (VRd) induction and consolidation and lenalidomide maintenance therapy reduced the risk of progression or death by 58 percent compared to standard of care If approved, the DARZALEX FASPRO®-based regimen has the potential to provide an effective quadruplet therapy for many patients with newly diagnosed multiple myeloma who are eligible for transplant

Clinical and real-world evidence data support treatment with ERLEADA® (apalutamide) and niraparib plus abiraterone acetate given with prednisone in patients with prostate cancer Additional updates will be presented on innovative targeted releasing systems TAR-200 and TAR-210 in bladder cancer

Data illustrates rapid and significant clearance in moderate to severe scalp psoriasis and significant improvement in scalp itch, as well as patient-reported health-related quality of life outcomes, including post-inflammatory pigmentation at 16 weeks First-of-its-kind study adds to growing body of evidence demonstrating that TREMFYA® is effective for adults with moderate to severe plaque psoriasis across all skin tones The VISIBLE clinical program will produce an expansive longitudinal collection of more than 20,000 clinical images across all skin tones to support patients and providers with disease recognition