KEY TAKEAWAYS
- The phase 1/2 MajesTEC-1 study featured an extended follow-up of teclistamab in RRMM patients.
- The study’s primary endpoint was ORR. Secondary endpoints were AEs, CRS, and ICANS.
- The study found teclistamab showed durable responses and an acceptable safety profile for RRMM pts.
Teclistamab stands as the only sanctioned BCMA×CD3 bispecific antibody that offers individualized, weight-based, and adaptable dosing for treating triple-class exposed RRMM. According to Moreau et al. (NEJM 2022), the treatment yields quick, profound, and lasting responses.
This update is based on the key phase 1/2 MajesTEC-1 study, featuring an extended follow-up of approximately 22 months.
The study focused on adults with documented multiple myeloma and who had received ≥3 prior lines of therapy (LOT), which included a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody. BCMA-targeted previous therapy was not permitted. Among the 165 qualified patients (pts), nearly 30% (49 pts) completed the trial.
Teclistamab was administered at a dosage of 1.5 mg/kg weekly, with the flexibility to transition to bi-weekly dosing upon achieving partial response after at least four treatment cycles in phase 1 or complete response lasting for six months or more in phase 2. The primary endpoint was overall response rate (ORR), while secondary endpoints included adverse events, cytokine release syndrome (CRS), and immune effector cell-associated neurotoxicity syndrome (ICANS).
As of December 9, 2022, 165 pts were administered teclistamab at the RP2D. The participants had a median age of 64, were primarily male (58%), and had a median of 5 previous lines of therapy. After 22 months of median follow-up, 43% reached or exceeded a complete response. The median duration of this response was 24 months.
Regarding side effects, hematologic issues were common, including neutropenia in 72% of pts and anemia in 54%. Infections were reported in 78% of pts. Cytokine release syndrome (CRS) was noted in 72% of pts, but was generally low-grade. Adverse neurological events occurred in 3% of pts but resolved. Six deaths related to the treatment were recorded, three of which were due to COVID-19. Among the 49 pts still participating in the study, about 90% have transitioned to bi-weekly dosing.
The study reported that teclistamab yielded promising, durable responses and has a manageable safety profile for RRMM pts.
Source: https://clml-soho2023.elsevierdigitaledition.com/476/index.html
Clinical Trials: https://classic.clinicaltrials.gov/ct2/show/NCT03145181
https://classic.clinicaltrials.gov/ct2/show/NCT04557098
Donk, N.v.d., Moreau, P., Garfall, A., Bhutani, M., Oriol, A., Nooka, A., Martin, T., Rosinol, L., Mateos, M-V., Bahlis, N., Popat, R., Besemer, B., Lopez, J.M., Krishnan, A., Delforge, M., Trancucci, D., Verona, R., Stephenson, T., Chastain, K., Sidana, S. Long‑Term Follow‑Up From MajesTEC‑1 of Teclistamab, a B‑Cell Maturation Antigen (BCMA) × CD3 Bispecific Antibody, in Patients With Relapsed/ Refractory Multiple Myeloma (RRMM).
