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Yael Cohen, MD, discusses primary efficacy findings from the phase 1/2 RedirecTT-1 trial, which is investigating the combination of teclistamab and talquetamab in patients with relapsed/refractory multiple myeloma.
Yael Cohen, MD, senior physician, Department of Hematology, Tel-Aviv Sourasky Medical Center, discusses primary efficacy findings from the phase 1/2 RedirecTT-1 trial (NCT04586426), which is investigating the combination of teclistamab-cqyv (Tecvayli) and talquetamab in patients with relapsed/refractory multiple myeloma.
The primary end points of the phase 1b portion of RedirecTT-1 were safety and the identification of the recommended phase 2 regimen (RP2R) and schedule for teclistamab plus talquetamab. The RP2R was determined to be 3.0 mg/kg of teclistamab plus 0.8 mg/kg of talquetamab administered subcutaneously every 2 weeks.
At a median follow-up of 13.4 months, the overall response rate (ORR) was 86.6% in the entire RedirecTT-1 trial population, including a complete response (CR)/stringent CR (sCR) rate of 40.2%. At a median follow-up of 8.1 months, the ORR was 96.3% in the patients who received teclistamab plus talquetamab at the RP2R, including a CR/sCR rate of 40.7%. At the data cutoff date, 61% of patients remained on the study treatment, and the median duration of response (DOR) was not evaluable (NE) in either cohort. In the entire study population, the median times to first and best response were 1.97 months and 3.98 months, respectively. In the RP2R cohort, the median times to first and best response were 1.48 months and 3.22 months, respectively.
This trial also included a subgroup of patients with soft tissue plasmacytoma, a subset of myeloma that is difficult to manage with off-the-shelf therapies, which produce response rates between 5% and 40%, Cohen says. Although CAR T-cell therapies elicit high response rates in these patients, those therapies have limited durability in that population. In RedirecTT-1, the ORR was 71.4% in all treated patients with soft tissue plasmacytomas, including a 21.2% CR/sCR rate. Furthermore, at a median follow-up of 7.2 months, the ORR in patients with soft tissue plasmacytomas who received the RP2R was 85.7%, with a CR/sCR rate of 28.6%. The median DOR was 12.9 months in those who received the combination at all dose levels and NE in those who received the RP2R. These findings are encouraging for patients with soft tissue plasmacytomas, Cohen concludes.
Disclosures: Dr Cohen reports honoraria from Amgen, GlaxoSmithKline, Janssen, Medison, NeoPharm, and Takeda; consulting or advisory roles with Amgen, GlaxoSmithKline, Janssen, and Medison; and research funding from Amgen (Inst), Karyopharm Therapeutics (Inst), and Takeda (Inst).