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FDA Accelerated Approval of Teclistamab-cqyv for Multiple Myeloma
November 2022: The first bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, teclistamab-cqyv (Tecvayli, Janssen Biotech, Inc.), was given accelerated approval by the Food and Drug Administration for adult patients with relapsed or refractory multiple myeloma who had previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38
MajesTEC-1 Clinical Trial Efficacy and Response Rates
MajesTEC-1 (NCT03145181; NCT04557098), a single-arm, multi-cohort, open-label, multi-center trial, tested teclistamab-cqyv. The effectiveness population comprised of 110 patients who had not previously received BCMA-targeted therapy and had previously received at least three medications, such as a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody.
Overall response rate (ORR), as evaluated by the Independent Review Committee assessment using International Myeloma Working Group 2016 criteria, served as the primary efficacy outcome measure. The ORR (95% CI: 52.1, 70.9) was 61.8%. The estimated duration of response (DOR) rate was 90.6% (95% CI: 80.3%, 95.7%) at 6 months and 66.5% (95% CI: 38.8%, 83.9%) at 9 months among respondents with a median follow-up of 7.4 months.
Safety Warnings and Tecvayli REMS Program
A Boxed Warning for neurologic damage, including immunological effector cell-associated neurotoxicity, and life-threatening or deadly cytokine release syndrome (CRS) is included in the prescribing information for teclistamab-cqyv (ICANS). Patients who received the indicated dose of teclistamab-cqyv experienced CRS in 72% of cases, neurologic damage in 57%, and ICANS in 6% of cases. Grade 3 CRS occurred in 0.6% of individuals, while 2.4% of patients experienced Grade 3 or 4 neurologic damage.
The only way to obtain teclistamab-cqyv is through a restricted programme run under a Risk Evaluation and Mitigation Strategy (REMS), known as the Tecvayli REMS, due to the dangers of CRS and neurologic toxicity, including ICANS.
Common Side Effects and Laboratory Abnormalities
The 165 patients in the safety population had pyrexia, CRS, musculoskeletal pain, injection site response, exhaustion, upper respiratory tract infection, nausea, headache, pneumonia, and diarrhoea as the most frequent side events (20%). A drop in lymphocytes, a decrease in neutrophils, a decrease in white blood cells, a decrease in haemoglobin, and a decrease in platelets were the most prevalent laboratory abnormalities in Grades 3 to 4 (20%).
Teclistemab-cqyv is administered subcutaneously in doses of 0.06 mg/kg on Day 1, 0.3 mg/kg on Day 4, 1.5 mg/kg on Day 7, and then 1.5 mg/kg each weekly until disease progression or intolerable toxicity.
View full prescribing information for Tecvayli.
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About Dr. Nishant Mittal
Dr. Nishant Mittal is a highly accomplished researcher with over 13 years of experience in the fields of cardiovascular biology and cancer research. Significant contributions to stem cell biology, developmental biology, and innovative research techniques mark his career. Research Highlights Dr. Mittal's research has focused on several key areas: 1) Cardio…
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This article is for educational purposes only and should not replace medical advice, diagnosis, or treatment from a qualified oncology specialist. Every patient's case is different. Treatment decisions should always be made after a review of complete medical records by the treating medical team.
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