Johnson & Johnson announced results from the Phase 3 MonumenTAL-3 study demonstrating that TALVEY plus DARZALEX FASPRO significantly reduced the risk of disease progression or death by up to 72% in patients with relapsed or refractory multiple myeloma. The combination therapy showed a progression-free survival rate of 81.3% compared to 51.2% for the standard of care at 24 months. Overall survival rates reached 89.2% versus 79.1% for the control arm, marking the first Phase 3 study to show superior progression-free survival with a GPRC5D bispecific antibody combination in earlier-line multiple myeloma. These results reinforce Johnson & Johnson's leadership in multiple myeloma, advancing bispecific combinations earlier in the treatment journey, and expanding options to match the right treatment to the right patient and stage of disease.

The MonumenTAL-3 study evaluated TALVEY with DARZALEX FASPRO (Tal-D) or TALVEY with DARZALEX FASPRO and pomalidomide (Tal-DP) against the standard regimen of DARZALEX FASPRO, pomalidomide, and dexamethasone (DPd). At a median follow-up of 24.6 months, the hazard ratio for progression-free survival was 0.28 for Tal-DP and 0.33 for Tal-D. Statistically significant improvements were observed across key secondary endpoints, including overall response rate, complete response or better, and minimal residual disease-negative status.

Efficacy and Safety Results

The study enrolled 864 patients who had received at least one prior line of therapy, with 85.1% refractory to lenalidomide and 93.4% refractory to their last line of therapy. The overall safety profiles for the TALVEY plus DARZALEX FASPRO arms were consistent with the known profiles of each monotherapy. A reduced risk of severe infections was observed in the Tal-D arm compared to the standard of care, with Grade 3/4 infection rates of 29.2% for Tal-D, 37.7% for Tal-DP, and 42.2% for DPd.

Regulatory Submissions

Based on these results, Johnson & Johnson has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration for the use of TALVEY and DARZALEX FASPRO, with or without pomalidomide, for the treatment of relapsed or refractory multiple myeloma after at least one prior line of therapy. A Type II variation application has also been submitted to the European Medicines Agency. The results were presented at the 2026 European Hematology Association Annual Meeting and published in The New England Journal of Medicine.

Johnson & Johnson on Thursday presented detailed results from its Phase 2/3 ENERGY study showing that IMAAVY (nipocalimab-aahu) achieved a statistically significant, durable hemoglobin response in patients with warm autoimmune hemolytic anemia (wAIHA). The randomized, placebo-controlled trial demonstrated that approximately three times as many patients achieved durable hemoglobin levels versus placebo by 24 weeks in the 30 mg/kg treatment group. These results mark a potential advancement for a rare, life-threatening condition with no FDA-approved therapies.

The primary endpoint of the study was durable hemoglobin improvement, defined as an increase from baseline of at least 2 g/dL, a concentration of at least 10 g/dL, maintained for at least three visits over 28 days starting by Week 16, without rescue therapy. In the 30 mg/kg group, a mean increase of 1 g/dL in hemoglobin was observed at Week 1, compared to no change in the placebo group. Nearly two-thirds of patients achieved both target hemoglobin levels by Week 24.

Key Findings from the ENERGY Study

The study evaluated the efficacy and safety of nipocalimab compared with placebo in adults living with wAIHA. Key secondary endpoints included improvements in fatigue and reduction in steroid use. Changes in patient-reported fatigue were observed as early as Week 2 and sustained throughout the 24-week treatment period.

IMAAVY demonstrated a safety profile consistent with its established profile in generalized myasthenia gravis. The most common adverse reactions in patients with wAIHA treated with IMAAVY were peripheral edema, diarrhea, and fever. The drug is designed to target pathogenic immunoglobulin G (IgG) autoantibodies while preserving key immune functions.

"These data from the Phase 2/3 ENERGY study showed the rapid onset of effect and durable improvement in anemia which occurs by targeting the autoantibody-mediated destruction of red blood cells," said Bruno Fattizzo, M.D., Assistant Professor at the Department of Oncology and Hematology-Oncology, University of Milan, Italy.

The results support the supplemental Biologics License Application (sBLA) for IMAAVY, which has been granted U.S. FDA Priority Review. The legal manufacturer for IMAAVY is Janssen Biotech, Inc., a Johnson & Johnson company.