Safety and Efficacy of Teclistamab in Patients with Relapsed/Refractory Multiple Myeloma: A Real-World Experience

• Published in: Transplantation and cellular therapy Vol. 30; no. 3; pp. 308.e1 - 308.e13
• Main Authors: Dima, Danai, Davis, James A., Ahmed, Nausheen, Jia, Xuefei, Sannareddy, Aishwarya, Shaikh, Hira, Shune, Leyla, Kaur, Gurbakhash, Khouri, Jack, Afrough, Aimaz, Strouse, Christopher, Lochner, Jonathan, Mahmoudjafari, Zahra, Raza, Shahzad, Valent, Jason, Anderson, Larry D., Anwer, Faiz, Abdallah, Al-Ola, Hashmi, Hamza
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.03.2024
• Subjects: Aged; Antibodies, Bispecific; Antineoplastic Agents - adverse effects; B-Cell Maturation Antigen; BCMA; Bispecific; Humans; Multiple myeloma; Multiple Myeloma - drug therapy; Neoplasms, Plasma Cell; Refractory; Relapsed; Retrospective Studies; T cell engager; Refractory; BCMA; Bispecific; Relapsed; Multiple myeloma; T cell engager
• ISSN: 2666-6367; 2666-6367
• DOI: 10.1016/j.jtct.2023.12.016

•Even though most patients in our study did not meet the eligibility criteria for the MajesTEC-1 trial, teclistamab was safe and effective in this real-world population.•Teclistamab yielded early and deep responses in heavily pretreated patients with relapsed/refractory multiple myeloma, including those with high-risk disease features and prior BCMA-directed therapies.•Extramedullary disease and poor performance status were associated with inferior best overall response rate and progression-free survival.•The incidence of severe cytokine release syndrome and immune effector cell-associated neurotoxicity syndrome was low, although the risk of cytopenias and related infections remained an ongoing challenge. Teclistamab is a B cell maturation antigen (BCMA)-directed bispecific antibody approved for relapsed/refractory multiple myeloma (RRMM) on the basis of the phase I/II MajesTEC-1 trial. Here we report clinical outcomes with standard-of-care teclistamab in a real-world RRMM population. A total of 106 patients from 5 academic centers who received teclistamab from August 2022 to August 2023 were included in this retrospective analysis, 83% of whom would have been considered ineligible for the MajesTEC-1 trial. All patients were triple-class exposed, 64% were penta-class refractory, and 53% had received prior BCMA-directed therapy. Cytokine release syndrome was observed in 64% of patients, and only 1 event was grade ≥3, whereas immune effector cell-associated neurotoxicity syndrome was observed in 14% of patients (3 events were grade 3 or 4). One-third (31%) of patients experienced at least 1 infection, with nearly half of these infections graded as severe (grade ≥3). The overall response rate (ORR) was 66%, and the complete or better response rate was 29%. The ORR was 47% for patients with extramedullary disease (EMD), 59% for patients with prior BCMA-directed therapy exposure, and 68% for patients with penta-refractory disease. At a median follow-up of 3.8 months, the median progression-free survival (PFS) was 5.4 months (95% CI, 3.4 months to not reached), while median overall survival was not reached. Patients with Eastern Cooperative Oncology Group Performance Status ≥2, EMD, and age ≤70 years had inferior PFS on multivariable analysis. Our study demonstrates reasonable safety and good efficacy of teclistamab in patients with RRMM treated in a real-world setting.