Johnson and Johnson Sees Durable PSA Reductions in Phase 1b, Files IMAAVY BLA
Johnson & Johnson’s pasritamig plus docetaxel combo in metastatic prostate cancer delivered durable PSA reductions with no unexpected safety issues in Phase 1b results at the ASCO GU Symposium. The company also filed a supplemental BLA for nipocalimab (IMAAVY) in wAIHA after Phase 2/3 data showed hemoglobin and fatigue improvements.
1. Phase 1b pasritamig Trial Results
Johnson & Johnson reported that the combination of pasritamig, a bispecific T-cell engager, with docetaxel produced durable reductions in prostate-specific antigen in metastatic prostate cancer patients. No unexpected safety concerns emerged, mirroring docetaxel’s known profile and strengthening the rationale for advancing to Phase 3 development.
2. Supplemental BLA Submission for IMAAVY
The company submitted a supplemental Biologics License Application for nipocalimab (IMAAVY) as a potential first treatment for warm autoimmune hemolytic anemia. Phase 2/3 ENERGY trial results showed rapid hemoglobin increases and meaningful fatigue improvements, underpinning the regulatory filing.