Anita D’Souza, MD, Medical College of Wisconsin, discusses results from the MajesTEC-2 and TRIMM-2 clinical trials for combination therapy teclistamab + daratumumab + pomalidomide (tec-DP) in patients with multiple myeloma.
Multiple myeloma is a bone marrow-based plasma cell neoplasm characterized by a serum monoclonal protein and skeletal destruction with osteolytic lesions, pathological fractures, bone pain, hypercalcemia, and anemia.
The MajesTEC-2 clinical trial is a multi-arm phase 1b study evaluating the safety and tolerability of teclistamab with other anticancer therapies in patients with multiple myeloma.
The TRIMM-2 clinical trial is phase 1b study evaluating subcutaneous daratumumab regimens in combination with bispecific T-cell redirection antibodies for the treatment of patients with multiple myeloma.
Teclistamab is the first approved B-cell maturation antigen x CD3 bispecific antibody for the treatment of relapsed/refractory multiple myeloma. Daratumumab is a human monoclonal antibody that targets CD38, a protein overexpressed in multiple myeloma cells. Pomalidomide is a thalidomide analogue that stimulates immune function and kills multiple myeloma cells.
Results
A total of 27 patients received weekly doses of teclisatamab (0.72, 0.75, or 1.5 mg/kg with step-up dosing) and approved schedules of daratumumab (1800 mg) and pomalidomide (2 or 4 mg; introduced following completion of step-up dosing).
Median follow-up was 25.8 months and median treatment duration of tec-DP was 12 months. The most common adverse events (AEs) in 50% or greater of patients included neutropenia, cough, and CRS. Grade three/four AEs in 15% or greater of patients included neutropenia, lymphopenia, anemia, COVID-19 pneumonia, and pneumonia. Infections occurred in 25 patients. Three patients discontinued treatment due to AEs and seven deaths occurred (one due to progressive disease and six due to infections).
Overall response rate was 88.5%, very good partial response or better rate was 84.6%, and complete response or better rate was 61.5%. Median time to first response was 0.95 months and median progression-free survival was 26.5 months.
Overall, tec-DP combination therapy showed favorable efficacy in patients with relapsed/refractory multiple myeloma. The frequency of infection emphasizes the importance of infection prophylaxis in these patients.
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