Teclistamab in Relapsed or Refractory Multiple Myeloma

Philippe Moreau, Alfred L. Garfall, Niels W.C.J. van de Donk, Hareth Nahi, Jesús F. San-Miguel, Albert Oriol, Ajay K. Nooka, Thomas Martin, Laura Rosinol, Ajai Chari, Lionel Karlin, Lotfi Benboubker, Maria Victoria Mateos, Nizar Bahlis, Rakesh Popat, Britta Besemer, Joaquín Martínez-López, Surbhi Sidana, Michel Delforge, Lixia PeiDanielle Trancucci, Raluca Verona, Suzette Girgis, Shun X.W. Lin, Yunsi Olyslager, Mindy Jaffe, Clarissa Uhlar, Tara Stephenson, Rian Van Rampelbergh, Arnob Banerjee, Jenna D. Goldberg, Rachel Kobos, Amrita Krishnan, Saad Z. Usmani

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40 Scopus citations


BACKGROUND Teclistamab is a T-cell-redirecting bispecific antibody that targets both CD3 expressed on the surface of T cells and B-cell maturation antigen expressed on the surface of myeloma cells. In the phase 1 dose-defining portion of the study, teclistamab showed promising efficacy in patients with relapsed or refractory multiple myeloma. METHODS In this phase 1-2 study, we enrolled patients who had relapsed or refractory myeloma after at least three therapy lines, including triple-class exposure to an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody. Patients received a weekly subcutaneous injection of teclistamab (at a dose of 1.5 mg per kilogram of body weight) after receiving step-up doses of 0.06 mg and 0.3 mg per kilogram. The primary end point was the overall response (partial response or better). RESULTS Among 165 patients who received teclistamab, 77.6% had triple-class refractory disease (median, five previous therapy lines). With a median follow-up of 14.1 months, the overall response rate was 63.0%, with 65 patients (39.4%) having a complete response or better. A total of 44 patients (26.7%) were found to have no minimal residual disease (MRD); the MRD-negativity rate among the patients with a complete response or better was 46%. The median duration of response was 18.4 months (95% confidence interval [CI], 14.9 to not estimable). The median duration of progression-free survival was 11.3 months (95% CI, 8.8 to 17.1). Common adverse events included cytokine release syndrome (in 72.1% of the patients; grade 3, 0.6%; no grade 4), neutropenia (in 70.9%; grade 3 or 4, 64.2%), anemia (in 52.1%; grade 3 or 4, 37.0%), and thrombocytopenia (in 40.0%; grade 3 or 4, 21.2%). Infections were frequent (in 76.4%; grade 3 or 4, 44.8%). Neurotoxic events occurred in 24 patients (14.5%), including immune effector cell-associated neurotoxicity syndrome in 5 patients (3.0%; all grade 1 or 2). CONCLUSIONS Teclistamab resulted in a high rate of deep and durable response in patients with triple-class-exposed relapsed or refractory multiple myeloma. Cytopenias and infections were common; toxic effects that were consistent with T-cell redirection were mostly grade 1 or 2.

Original languageEnglish
Pages (from-to)495-505
Number of pages11
JournalNew England Journal of Medicine
Issue number6
StatePublished - 11 Aug 2022


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