· Johnson & Johnson will present 30+ abstracts at European Hematology Association 2026, highlighting leadership in hematology with data across multiple myeloma and leukemia, and first pivotal data in warm autoimmune hemolytic anemia
· Phase 3 results evaluate the potentially transformative investigational combination of TALVEY®, the first GPRC5D‑targeted bispecific antibody, in combination with DARZALEX FASPRO® with or without pomalidomide for patients with relapsed or refractory multiple myeloma in earlier lines of therapy
· Pivotal Phase 2/3 results potentially position IMAAVY® as the first FDA-approved treatment for warm autoimmune hemolytic anemiaa designed to target the IgG autoantibodies responsible for red blood cell destruction
SPRING HOUSE, Pa., (May 12, 2026) – Johnson & Johnson (NYSE: JNJ) announced today more than 30 hematology abstracts featuring data in multiple myeloma and leukemia, as well as in warm autoimmune hemolytic anemia (wAIHA), will be shared at the European Hematology Association (EHA) 2026 Congress from June 11-14 in Stockholm, Sweden. Among the results to be presented in a plenary session is the Phase 3 MonumenTAL-3 study investigating TALVEY® (talquetamab-tgvs), a GPRC5D bispecific antibody, in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) with or without pomalidomide in relapsed/refractory multiple myeloma. New pivotal data from the Phase 2/3 ENERGY study evaluating IMAAVY® (nipocalimab-aahu)a in wAIHA, a rare autoantibody-driven disease in which autoantibodies attach to and destroy red blood cells, will also be presented in an oral session.1 The U.S. Food and Drug Administration (FDA) recently granted Priority Review to IMAAVY ® in wAIHA.
Perspectives on key data readouts at EHA
“The data we are sharing at EHA 2026 reflect the depth and breadth of our clinical innovations in blood cancer, led by the Phase 3 MonumenTAL-3 results, which are an exciting next step in exploring how we can continue to expand our portfolio of differentiated and combinable therapies in multiple myeloma,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson. “Together with additional data in leukemia, these findings underscore our leadership in hematology and our continued commitment to advancing meaningful innovation for patients living with complex blood cancers.”
“wAIHA is marked by debilitating fatigue and serious complications of severe anemia. There is an unmet need for an approved treatment for wAIHA that may provide rapid control and sustained relief from symptoms while preserving critical immune functions,” said David Lee, M.D., Ph.D., Global Immunology Therapeutic Area Head, Johnson & Johnson. “The first presentation of Phase 2/3 results from the ENERGY study highlights the potential of an immunoselective treatment approach for wAIHA, which is a rare disease with no U.S. FDA-approved treatments.”
Updated data in multiple myeloma
Data at EHA will highlight advances in multiple myeloma treatment, including combination regimens and emerging therapies for patients with newly diagnosed and relapsed/refractory multiple myeloma.
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New results from the Phase 3 MonumenTAL-3 study evaluating TALVEY® in combination with DARZALEX FASPRO® with or without pomalidomide versus DARZALEX FASPRO®, pomalidomide, and dexamethasone in relapsed/refractory multiple myeloma (Presented as “One of the six best abstracts” during the Plenary Abstracts Session #S100)
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Subgroup analysis based on cytogenetic and functional risk from the MajesTEC-3 study evaluating TECVAYLI® (teclistamab-cqyv) in combination with DARZALEX FASPRO® in relapsed/refractory multiple myeloma (Oral Abstract #S198)
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Cytogenetic subgroup analysis from the Phase 3 CARTITUDE-4 study evaluating CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) in patients with lenalidomide-refractory multiple myeloma responding to bridging therapy (Poster Abstract #PF767) [Encore of ASCO 2026]
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Subgroup analysis from the Phase 3 PERSEUS study evaluating the benefit of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in transplant-eligible patients with high- and standard-risk multiple myeloma (Poster Abstract #PS1869) [Encore of ASCO 2026]
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Final subgroup analysis from the Phase 3 CEPHEUS study evaluating DARZALEX FASPRO® in combination with bortezomib, lenalidomide, and dexamethasone in transplant-ineligible newly diagnosed multiple myeloma (Oral Abstract #S196) [Encore of ASCO 2026]
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Results from the Phase 3 MajesTEC-9 study of TECVAYLI® versus standard of care therapies as early as second line in patients with multiple myeloma (Oral Abstract #S195) [Encore of ASCO 2026]
New research in warm autoimmune hemolytic anemia (wAIHA)
Pivotal study assessed hemoglobin response and fatigue improvement compared to placebo in patients with warm autoimmune hemolytic anemia.
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Results from the pivotal ENERGY Phase 2/3 study evaluating the efficacy and safety of IMAAVY® in patients with wAIHA compared with placebo (Oral Abstract #S300)
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Assessment of the effects of IMAAVY® on fatigue in patients with wAIHA, measured using the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) scale (Oral Abstract #S325)
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Confirmatory evidence on the pharmacodynamic effect of IMAAVY® and the correlation with clinical improvement in patients with wAIHA (Poster Abstract #PF1297)
Key data presentations in leukemia
New and updated data highlight clinical advances in leukemia, including acute myeloid leukemia (AML) and chronic lymphocytic leukemia (CLL), across targeted therapies and fixed-duration treatment approaches.
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Safety analyses from the cAMelot-1 and ALE1002 clinical trials of bleximenib (JNJ-75276617), an investigational oral menin inhibitor, evaluating the presence of QTc interval prolongation when given as monotherapy or in combination with AML-directed therapies for KMT2A or NPM1 Altered AML (Poster Abstract #PF555)
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Primary analysis from the Phase 2 TAILOR study evaluating the safety and efficacy of dose-modified fixed-duration IMBRUVICA® (ibrutinib) plus venetoclax in previously untreated CLL (Poster Abstract #PF606)
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Real-world analysis from the prospective REALITY-WW study evaluating first-line fixed-duration IMBRUVICA® in combination with venetoclax in patients with CLL (Poster Abstract #PF613)
Information on Johnson & Johnson sponsored abstracts is available on JNJ.com.
Editor’s Notes
a. IMAAVY® is not approved by the U.S. FDA for the treatment of wAIHA
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