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Teclistamab in Relapsed or Refractory Multiple Myeloma.
Moreau, Philippe; Garfall, Alfred L; van de Donk, Niels W C J; Nahi, Hareth; San-Miguel, Jesús F; Oriol, Albert; Nooka, Ajay K; Martin, Thomas; Rosinol, Laura; Chari, Ajai; Karlin, Lionel; Benboubker, Lotfi; Mateos, Maria-Victoria; Bahlis, Nizar; Popat, Rakesh; Besemer, Britta; Martínez-López, Joaquín; Sidana, Surbhi; Delforge, Michel; Pei, Lixia; Trancucci, Danielle; Verona, Raluca; Girgis, Suzette; Lin, Shun X W; Olyslager, Yunsi; Jaffe, Mindy; Uhlar, Clarissa; Stephenson, Tara; Van Rampelbergh, Rian; Banerjee, Arnob; Goldberg, Jenna D; Kobos, Rachel; Krishnan, Amrita; Usmani, Saad Z.
  • Moreau P; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Garfall AL; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • van de Donk NWCJ; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Nahi H; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • San-Miguel JF; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Oriol A; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Nooka AK; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Martin T; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Rosinol L; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Chari A; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Karlin L; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Benboubker L; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Mateos MV; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Bahlis N; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Popat R; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Besemer B; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Martínez-López J; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Sidana S; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Delforge M; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Pei L; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Trancucci D; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Verona R; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Girgis S; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Lin SXW; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Olyslager Y; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Jaffe M; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Uhlar C; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Stephenson T; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Van Rampelbergh R; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Banerjee A; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Goldberg JD; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Kobos R; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Krishnan A; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
  • Usmani SZ; From the Hematology Clinic, University Hospital Hôtel-Dieu, Nantes (P.M.), Service d'Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite (L.K.), and Service d'Hématologie et Thérapie Cellulaire, Hôpital Bretonneau, Centre Hospitalier Régional Universitaire, Tours (L.B.) - all in France;
N Engl J Med ; 387(6): 495-505, 2022 08 11.
Article in English | MEDLINE | ID: covidwho-2031919
ABSTRACT

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. (Funded by Janssen Research and Development; MajesTEC-1 ClinicalTrials.gov numbers, NCT03145181 and NCT04557098.).
Subject(s)

Full text: Available Collection: International databases Database: MEDLINE Main subject: CD3 Complex / Antibodies, Bispecific / B-Cell Maturation Antigen / Antineoplastic Agents, Immunological / Multiple Myeloma Type of study: Cohort study / Prognostic study Limits: Humans Language: English Journal: N Engl J Med Year: 2022 Document Type: Article

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Full text: Available Collection: International databases Database: MEDLINE Main subject: CD3 Complex / Antibodies, Bispecific / B-Cell Maturation Antigen / Antineoplastic Agents, Immunological / Multiple Myeloma Type of study: Cohort study / Prognostic study Limits: Humans Language: English Journal: N Engl J Med Year: 2022 Document Type: Article