First results of the rwe prospective study TEC care (IFM 2023-01) evaluating teclistamab in triple-class exposed relapsed refractory multiple myeloma patients.

Abstract

Abstract Introduction Teclistamab was the first approved BCMAxCD3 bispecific antibody for the treatment of patients with relapsed refractory multiple myeloma (RRMM) previously exposed to a proteasome inhibitor (PI), an immunomodulatory drug (IMiD), and an anti-CD38 antibody based on the data from MajesTEC-1 clinical trial. To date, several retrospective studies reporting teclistamab outcomes in the real world have been published, but inherent limitations of these cohorts make prospective RWE studies necessary. Here, we present the results from the first interim analysis of Tec-Care, the first prospective study describing real-world effectiveness and safety of teclistamab in triple-class exposed RRMM. Methods Tec-Care is a prospective, multicenter, observational study from the Intergroupe Francophone du Myelome (IFM 2023-01). Patients could be included in the study if they had confirmed RRMM and had received at least one dose of teclistamab through the French early access program. The primary objective of the study was the overall response rate (ORR). Secondary objectives included very good partial response rates (VGPR), complete response rates (CR), time to next treatment (TTNT), progression-free survival (PFS), overall survival (OS), safety and treatment management. Results A total of 199 patients were enrolled in 31 IFM centers from September 2023 to December 2024. Median age was 73.2 years old [range 45-94]and median number of prior lines was 4 [range 1-15]. 65.8% of patients were triple-class refractory and 30.2% were penta-refractory. 27 patients (13.6%) received prior anti BCMA therapy. 19% of patients had extramedullary disease and 32% had high risk cytogenetics. With a median follow-up of 10.6 months, the 6-months ORR was 65.8% with 53.3% being VGPR or better. Response rates were consistent between the overall cohort and the subgroups analyzed. At 10 months, estimate PFS and OS rates were 56% [CI 95% 49%-63%] and 68,5% [CI 95% 61%-75%], but longer follow up is needed. Regarding safety, cytokine release syndrome (CRS) occurred in 66 (33.2%) patients (no grade >2), Immune cell-associated neurotoxicity syndrome (ICANS) occurred in 8 (4%) patients (including 1 grade 3), 36.8% of patients experienced grade >=2 infection with 12.6% of grade 3 or more, 71.4 % of patients received at least one polyvalent immunoglobulin dose since teclistamab initiation with a median starting time of 19 days (IQR 9-39), 12% of patients received at least one outpatient administration of teclistamab step-up doses. ConclusionIn conclusion, the prospective TEC CARE study confirms the effectiveness and safety profile of teclistamab in real-world patients with triple-class exposed relapsed/refractory multiple myeloma (RRMM), consistent with clinical trial data, thereby supporting its use as a standard treatment in this setting.