The Food and Drug Administration (FDA) has granted accelerated approval to Tecvayli™ (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received 4 or more prior lines of therapy, including a proteasome inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.
Tecvayli is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells. In vitro, teclistamab-cqyv activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells.
The accelerated approval was based on data from the single-arm, open-label, multicenter MajesTEC-1 study (ClinicalTrials.gov Identifier: NCT03145181 [Phase 1] and NCT04557098 [Phase 2]), which evaluated the efficacy and safety of teclistamab-cqyv in 110 adults with relapsed or refractory multiple myeloma who had previously received at least 3 prior therapies, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. Patients received teclistamab-cqyv via subcutaneous injection at step-up doses of 0.06mg/kg and 0.3mg/kg followed by 1.5mg/kg once weekly thereafter.
Findings showed an overall response rate (primary endpoint) of 61.8% (95% CI, 52.1-70.9); 28.2% of patients achieved complete response or better, 29.1% achieved very good partial response, and 4.5% achieved partial response. The median time to first response was 1.2 months (range, 0.2 to 5.5 months). With a median follow-up of 7.4 months among responders, the estimated duration of response 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.
“In the pivotal teclistamab study, we have continued to observe positive results in heavily pretreated patients with relapsed or refractory multiple myeloma,” said Ajai Chari, MD, Professor of Medicine, Division of Hematology and Medical Oncology at the Icahn School of Medicine at Mount Sinai and study investigator. “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.”
As for safety, teclistamab-cqyv carries a Boxed Warning for life threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity. Due to the risk of CRS and neurologic toxicity, teclistamab-cqyv will be available only through the Risk Evaluation and Mitigation Strategy (REMS) called the Tecvayli REMS.
The most common adverse reactions reported were pyrexia, CRS, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia, diarrhea, and laboratory abnormalities.
Tecvayli is supplied as 30mg/3mL and 153mg/1.7mL of teclistamab-cqyv in single-dose vials.
- FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma. News release. US Food and Drug Administration. Accessed October 26, 2022. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-teclistamab-cqyv-relapsed-or-refractory-multiple-myeloma
- US FDA approves Tecvayli™ (teclistamab-cqyv), the first bispecific T-cell engager antibody for the treatment of patients with relapsed or refractory multiple myeloma. News release. Janssen Pharmaceutical Companies of Johnson & Johnson. Accessed October 26, 2022. https://www.prnewswire.com/news-releases/us-fda-approves-tecvayli-teclistamab-cqyv-the-first-bispecific-t-cell-engager-antibody-for-the-treatment-of-patients-with-relapsed-or-refractory-multiple-myeloma-301659083.html
- Tecvayli. Package insert. Janssen Biotech, Inc.; 2022. Accessed October 26, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761291s000lbl.pdf