Tecvayli, First Bispecific BCMA-Directed CD3 T-Cell Engager, Received FDA Approval for Relapsed or Refractory Multiple Myeloma

December 2022 Vol 15, No 4 - FDA Oncology Update

On October 25, 2022, the FDA accelerated the approval of teclistamab-cqyv (Tecvayli; Janssen Biotech), the first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who received ≥4 previous lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody. The FDA granted teclistamab breakthrough therapy and orphan drug designations.

“In the pivotal teclistamab study, we have continued to observe positive results in heavily pretreated patients with relapsed or refractory multiple myeloma,” said study investigator Ajai Chari, MD, Director of Clinical Research, Multiple Myeloma Program, Icahn School of Medicine, Mount Sinai, New York City. “The approval of teclistamab, as the first bispecific antibody in relapsed or refractory multiple myeloma, is a meaningful step in helping many of these hard-to-treat patients.”

The FDA approved teclistamab based on the results of the MajesTEC-1 clinical trial, a single-arm, multicohort, open-label, multicenter study. The efficacy was evaluated in 110 patients who had received ≥3 previous therapies, including a PI, an IMiD, and an anti-CD38 monoclonal antibody, and had not received previous BCMA-targeted therapy.

The overall response rate, the study’s main efficacy measure, with teclistamab was 61.8% (95% confidence interval [CI], 52.1-70.9). With a median follow-up of 7.4 months, the estimated duration of response was 90.6% (95% CI, 80.3%-95.7%) at 6 months and 66.5% (95% CI, 38.8%-83.9%) at 9 months.

The most common (≥20%) adverse events in the 165 patients in the safety population were pyrexia, cytokine release syndrome (CRS), musculoskeletal pain, injection-site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea. The most common (≥20%) grade 3 or 4 laboratory events were decreased levels of lymphocytes, neutrophils, white blood cells, hemoglobin, and platelets.

The prescribing information for teclistamab includes a boxed warning regarding CRS and neurologic adverse events, including immune effector cell–associated neurotoxicity syndrome (ICANS). In the study, 72% of the patients had CRS, including 0.6% grade 3; 57% had neurologic adverse events, including 2.4% grade 3 or 4; and 6% had ICANS. Therefore, teclistamab was approved with a REMS (Risk Evaluation and Mitigation Strategy) program.

The recommended dose of teclistamab is 0.06 mg/kg by subcutaneous injection on day 1, 0.3 mg/kg on day 4, and 1.5 mg/kg on day 7, followed by 1.5 mg/kg once weekly, until disease progression or unacceptable adverse events.

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Last modified: December 21, 2022
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