Innovative Medicine
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Johnson & Johnson showcases continued hematology leadership and next-generation innovation at ASH 2026
· New TECVAYLI® (teclistamab-cqyv) + TALVEY® (talquetamab-tgvs) Phase 3 data demonstrate reduced risk of disease progression in relapsed or refractory multiple myeloma as early as second line · First results from ramantamig, an investigational trispecific antibody, with DARZALEX® (daratumumab) and lenalidomide in transplant-eligible newly diagnosed multiple myeloma showed deep and durable responses across multiple lines of therapy · Positive Phase 2 results for bleximenib in relapsed or refractory acute myeloid leukemia with KMT2A rearrangements or NPM1 mutations, supported by two Breakthrough Therapy Designations · First data for a novel, potentially disease-modifying CALRmut × CD3 T-cell engaging antibody targeting a disease-defining driver mutation in essential thrombocythemia, supported by Breakthrough Therapy and Priority Medicines designations -
Johnson & Johnson Announces CAPLYTA (lumateperone) Shows Significant and Rapid Improvement in Bipolar Mania in Second Pivotal Phase 3 Study
· CAPLYTA improved manic symptoms versus placebo as early as Day 3, with improvement sustained through Week 3 and a safety and tolerability profile consistent with prior studies · Two positive Phase 3 studies will support a planned U.S. FDA submission of CAPLYTA for bipolar mania, reinforcing its potential to address both depressive and manic episodes of bipolar disorder -
Johnson & Johnson reports 73% PSA response rate with investigational pasritamig-based immunotherapy combination in advanced prostate cancer
· First-of-its-kind dual-antigen-targeted bispecific regimen of pasritamig and JNJ-9401 directed at two prostate cancer proteins, KLK2 and PSMA, using complementary signals to activate T cells against cancer · Deep and sustained PSA responses observed with every-six-week dosing, with 73% (11 of 15 patients) achieving reductions of at least 50% and nearly half achieving reductions of at least 90% in Phase 1 study · With an encouraging safety profile, findings show potential for outpatient dosing as the combination advances to Phase 3 -
Johnson & Johnson announces new Phase 2 nipocalimab study data in Sjögren’s disease that reveal insights on importance of symptom improvements most valued by patients
· New patient experience dataa to be presented at ACR 2026 show mouth dryness was reported as the most important symptom to improve, followed by eye dryness, fatigue and joint pain · Patient insights complement Phase 2 study results demonstrating a 50% increase in saliva productionb in more than twice as many patients on nipocalimab compared to placeboc · Two Phase 3 studies are ongoing, evaluating nipocalimab in Sjögren’s disease including these measures critical to patients -
Johnson & Johnson announces ICOTYDE® (icotrokinra) delivers significant improvement in psoriatic arthritis disease activity among biologic-naive patients with once-daily targeted oral peptide
· Late-breaking data from Phase 3 investigational study presented at the American College of Rheumatology Convergence show 58% of ICOTYDE-treated patients achieved an ACR20 response and 29% achieved an ACR50 response at Week 16 · ICOTYDE is a first-in-class IL-23R targeted oral peptide, demonstrating significant joint and skin improvements and a favorable safety profile in a once-daily pill -
Johnson & Johnson announces U.S. FDA Approval of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) as First and Only Dual-Targeted Therapy for Advanced Head and Neck Cancer
· Accelerated approval based on data demonstrating clinically meaningful efficacy, including a 42 percent overall response rate (95 percent confidence interval, 32–52 percent)1 · First advancement in the second-line treatment setting for recurrent or metastatic head and neck cancer in a decade, bringing a new subcutaneous option to patients with significant unmet need 2-3 · Extending its well-established, dual-targeted benefit beyond lung cancer, RYBREVANT FASPRO™ targets both EGFR and MET pathways – two key drivers of tumor progression in head and neck cancer 2 -
RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) combination demonstrates 77% overall response rate in first-line treatment of patients with advanced head and neck cancer
Responses were deep and durable, with 65% ongoing at clinical cutoff Results support continued evaluation of the investigational RYBREVANT FASPRO regimen in the ongoing first-line Phase 3 study Data highlight the role of dual-targeting EGFR and MET, key drivers of tumor growth and resistance seen in 80 to 90 percent of HNSCC -
Johnson & Johnson announces ERLEADA® (apalutamide) treatment before and after surgery reduces risk of recurrence or death by 62% versus surgery alone in high-risk prostate cancer
· New substudy results showed a 51% lower estimated risk of metastasis or death over time with perioperative apalutamide plus ADT compared with immediate surgery · Twice as many patients remained free from subsequent treatment at three years with perioperative apalutamide plus ADT compared with surgery alone · Results evaluated outcomes versus surgery alone, building on the primary results presented at ASCO 2026 -
Johnson & Johnson advances the next generation of solid tumor therapies with new data at ESMO 2026
· First readout following acquisition of the RIPTAC™ platform shows promising anti-tumor activity with JNJ-6143, a novel oral investigational molecule, in difficult-to-treat prostate cancer · New first-line head and neck cancer data highlight the potential of RYBREVANT FASPRO™ (amivantamab and hyaluronidase-lpuj) and its dual EGFR-MET approach, building on the established role of RYBREVANT®-based regimens in lung cancer · New ERLEADA® (apalutamide) substudy findings in prostate cancer build on the primary results presented at ASCO 2026