KEY TAKEAWAYS
- The MajesTEC-1 phase I and II trials aimed to evaluate biweekly dosing of teclistamab for the durability of clinical response in RRMM patients.
- The result demonstrated sustained efficacy in maintaining remission after initial QW treatment.
For the study, researchers aimed to evaluate the biweekly dosing of teclistamab for the durability of clinical response in RRMM patients. In patients with triple-class exposed RRMM and ≥3 prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug, and anti-CD38 antibody, prior BCMA-targeted therapy was not allowed.
Of 165 eligible patients, 158 (96.9%) completed the study. Teclistamab was administered at a Recommended Phase II dose (RP2D) of 1.5 mg/kg weekly, with an option to switch to bi-weekly dosing if a confirmed partial response or better was achieved after ≥4 cycles (Phase I) or a confirmed complete response or better was maintained for ≥6 months (Phase II).
Of 165 patients receiving teclistamab at the Recommended Phase II Dose (RP2D), 104 responders switched to bi-weekly dosing; 50 met protocol-defined criteria, and 10 switched without meeting criteria (4 due to adverse events [AEs]; 6 for other reasons). Switched patients had a median age of 64, 58% male, 25% high-risk cytogenetics, and 75% triple-class refractory.
At the switch, 82% achieved ≥CR, and 18% had a very good partial response. The median time to switch was 11.1 months (range, 3–20). At 11.1-month(range, 2–24) follow-up post-switch, median response duration was 20.5 months(range, 1–23), with 40/60 patients still responding. Among others, 13/60 progressed, 2 discontinued due to AEs, 1 for other reasons, and 4 died (median time from switch to progression not estimable).
The result demonstrated sustained efficacy in maintaining remission after initial QW treatment, and the additional results will be presented.
Source: https://clml-soho2023.elsevierdigitaledition.com/476/index.html
Clinical Trials: https://clinicaltrials.gov/study/NCT03145181
https://clinicaltrials.gov/study/NCT04557098
Usmani SZ, Karlin L, Benboubker L, Nahi H, San-Miguel J, Trancucci D, Qi K, Stephenson T, Perales Puchalt A, Chastain K, Chari A. Durability of Responses With Biweekly Dosing of Teclistamab in Patients With Relapsed/Refractory Multiple Myeloma Achieving a Clinical Response in the MajesTEC‑1 Study. Presented at SOHO 2023.
