In October 2022, the FDA approved Tecvayli (teclistamab-cqyv; from Janssen Biotech), the first bispecific BCMA-directed CD3 T-cell engager, for the treatment of adults with relapsed or refractory multiple myeloma who received 4 or more previous lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.
“In the pivotal teclistamab [Tecvayli] 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 Tecvayli based on the efficacy results of a clinical trial with 110 patients who had received 3 or more previous therapies, including a PI, an IMiD, and an anti-CD38 monoclonal antibody, and had not received BCMA-targeted therapy.
Overall, the majority (61.8%) of the patients had a response to treatment with Tecvayli. After 6 months of therapy, the estimated response to treatment was 90.6%, which was reduced to 66.5% by 9 months.
Tecvayli is associated with cytokine release syndrome, a life-threatening side effect that must be carefully monitored. The most common side effects with Tecvayli were pyrexia, cytokine release syndrome, musculoskeletal pain, injection-site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhea.
