FDA Approves sBLA for Reduced Dosing Frequency of Teclistamab-cqyv for Patients With RRMM

The FDA has approved teclistamab-cqyv (Tecvayli; Janssen Biotech, Inc.) for a supplemental Biologics License Application (sBLA) for a reduced dosing frequency in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR) or better for at least 6 months. The reduced dosing frequency of 1.5 mg/kg is to be administered every 2 weeks (Q2W) and allows flexibility in dosing schedule for appropriate patients with a weight-based regimen.

Teclistamab was the first bispecific antibody that targets B-cell maturation antigen (BCMA) on multiple myeloma cells and CD3 T-cells to activate an immune response. This subcutaneous treatment was approved in October 2022 for patients with RRMM who have received at least 4 prior lines of therapy including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. The indication is approved under accelerated approval based on response rate, and continued approval for this indication may be dependent on the verification of the treatment in further clinical trials.

"[Teclistamab] is the only BCMA-targeted immune-based therapy with weight-based dosing. Today's approval of biweekly dosing for eligible patients will further enable clinicians to meet the individual needs of patients who may want flexibility in their dosing schedules," said Rachel Kobos, MD, vice president, Oncology Research & Development, Johnson & Johnson Innovative Medicine, in a press release.

The sBLA approval comes after results from the single-arm, open-label, multicohort, multicenter, dose-escalation MajesTEC-1 study, a phase 1 (NCT03145181) and phase 2 (NCT04557098) study that evaluated the safety and efficacy of teclistamab in 165 adult patients with RRMM who received 3 or more prior lines of therapy.

Phase 1 of the study consisted of 2 parts, dose escalation and dose expansion, that evaluated teclistamab’s safety, tolerability, pharmacokinetics, and preliminary efficacy in adult patients with RRMM. Phase 2 evaluated the efficacy of teclistamab at the recommended phase 2 dose (subcutaneous administrations of 1.5 mg/kg per week) as measured by overall response rate (ORR). Patients in the phase 2 trial who achieved a confirmed CT or better for 6 months or longer were eligible to reduce dosing frequency to the recommended phase 2 dose until disease progression or unacceptable toxicity.

The most common adverse events (≥20%) reported by patients were pyrexia, CRS, musculoskeletal pain, injection site reactions, upper respiratory tract infections, nausea, headache, pneumonia, and diarrhea. Further, the most common grade 3 to 4 laboratory abnormalities (≥20%) were decreases in lymphocytes, neutrophils, white blood cells, hemoglobin, and platelets.

"As the first bispecific approved for the treatment of multiple myeloma, combined with the longest in-market experience by physicians, [teclistamab] is another example of our commitment to pioneering cutting-edge research to help improve outcomes for patients with multiple myeloma," said Kobos in the press release.

Reference

Johnson & Johnson. TECVAYLI® (teclistamab-cqyv) biweekly dosing approved by the U.S. FDA for the treatment of patients with relapsed or refractory multiple myeloma. News release. February 20, 2024. Accessed February 21, 2024. https://www.prnewswire.com/news-releases/tecvayli-teclistamab-cqyv-biweekly-dosing-approved-by-the-us-fda-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-302066627.html?tc=eml_cleartime