Among patients with relapsed or refractory multiple myeloma (MM), teclistamab appears to yield a high rate of deep and durable responses without inducing excessive toxicity, according to the results of a phase 1/2 study published in The New England Journal of Medicine.
Although novel treatments have improved outcomes among patients with MM over the past several decades, it is unclear how best to treat individuals who progress after these therapies. Outcomes are typically poor after progression in this patient population.
Previous research has suggested that the B cell maturation antigen (BCMA) may be an actionable target in the MM setting. Teclistamab, a bispecific antibody, was designed to target both CD3 expressed on T cell surfaces and BCMA on MM cell surfaces.
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Prior phase 1 study in the MajesTEC-1 trial (ClinicalTrials.gov Identifiers: NCT03145181 and NCT04557098) suggested a recommended phase 2 teclistamab dose of 1.5 mg per kilogram of body weight on a weekly basis. In the present paper, researchers reported efficacy and safety results from the phase 1/2 portion of MajesTEC-1.
Overall, 165 patients were enrolled to the phase 1 (40 patients) and phase 2 (125) portions of this study. All patients had relapsed or refractory MM. In the overall cohort, the median age was 64 years (range, 33-80), 58.2% of patients were male sex, the median time since MM diagnosis was 6 years, 25.7% of patients had high-risk cytogenetics, and the median number of prior therapy lines was 5 (range, 2-14).
The median follow-up was 14.1 months. At this point, the overall response rate was 63%, and 39.4% of patients had at least a complete response; the minimal residual disease-negativity rates in the overall cohort and in patients with a complete response or better were 26.7% and 46%, respectively.
The median response duration was 18.4 months (95% CI, 14.9-not estimable); the median progression-free survival was 11.3 months (95% CI, 8.8-17.1).
Grade 3 or worse adverse events included cytokine release syndrome (0.6%), neutropenia (64.2%), anemia (37%), thrombocytopenia (21.2%), and infection (44.8%).
“The high rate of deep and durable responses in this population indicates the potential for teclistamab to provide substantial clinical benefit to a broader population of patients,” the authors wrote. “Toxic effects were also common but were mainly of low grade and reversible.”
Disclosure: The study author(s) declared affiliations with biotech, pharmaceutical, or device companies. Please see the original reference for a full list of authors’ disclosures.
Reference
Moreau P, Garfall AL, van de Donk NWCJ, et al. Teclistamab in relapsed or refractory multiple myeloma. Published online June 5, 2022. N Engl J Med. doi:10.1056/NEJMoa2203478
