1. Patients on the recommended phase 2 dosage of teclistamab had no dose-limiting adverse events.
2. There was a 65% overall response rate seen in patients on the recommended dosage of teclistamab that persisted and increased overtime.
Evidence Rating Level: 1 (Excellent)
Study Rundown: Multiple myeloma is the second most common blood cancer in the world. There is currently no curative therapy for multiple myeloma; however, the rapid development of novel immunotherapies has prolonged survival in the past 5 years. This phase 1 study focuses on determining the recommended phase 2 dosage of a new biologic, teclistamab, a BCMA x CD3 T-cell redirecting bispecific antibody. 157 refractive multiple myeloma patients were enrolled into the study and were randomized into either intravenous (IV) or subcutaneous treatment. A recommended phase 2 dosage was theorized using existing drug data of 1500 ug/kg teclistamab subcutaneously once per week. While two dose-limiting events occurred in IV patients, no dose-limiting toxicities were seen at the recommended phase 2 dose. The most common adverse events were cytokine release syndrome and neutropenia. In the patients on recommended dose, just over half achieved a partial or better response. Limitations of this study included the low sample size and single-arm design. Nevertheless, this study demonstrated the safety and efficacy of recommended dose for the ongoing phase 2 study.
In-Depth [randomized controlled trial]: This open-label, single-arm, phase 1 drug study of the biologic, teclistamab, is an ongoing study in 12 hospitals centers in USA, Spain, France, the Netherlands, and Sweden. 157 patients were separated into two cohorts of IV (n=84) and subcutaneous (n=73) administration. The median age of the patients was 63 years and 54% were male. The eligible patient population had relapsed, refractory, or treatment-resistant multiple myeloma. 40 patients were put on the phase 2 recommended subcutaneous dosage of 1500 ug/kg once per week. No dose-limiting toxicities were seen in this population, but adverse events such as cytokine release syndrome (28/40) and neutropenia (26/40) did occur. In the recommended dose group, overall response rate was 65% (95% CI 48-79) and the median time to the first confirmed response was 1 month. No median duration of response was reached. 85% (22/26) of the responders were alive after the 7.1 median follow-up period.
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