FDA approves Tecvayli for advanced multiple myeloma
The FDA granted accelerated approval to teclistamab-cqyv for treatment of certain patients of myeloma.
The indication applies to use of teclistamab-cqyv (Tecvayli, Janssen Biotech) for adults with relapsed or refractory multiple myeloma who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 monoclonal antibody.
Teclistamab-cqy is a bispecific B-cell maturation antigen-directed CD3 T-cell engager.
The FDA based the approval on results of the single-arm, multi-cohort, open-label, multicenter MajesTEC-1 study.
The efficacy population included 110 patients who had received at least three therapies — including a proteasome inhibitor, immunomodulatory agent and anti-CD38 monoclonal antibody — but had not received BCMA-targeted therapy.
Overall response rate per independent review committee assessment served as the main efficacy outcome.
Researchers reported an ORR of 61.8% (95% CI, 52.1-70.9). Investigators reported a median response duration of 7.4 months, with 90.6% (95% CI, 80.3-95.7) of responses lasting at least 6 months and 66.5% (95% CI, 38.8-83.9) lasting at least 9 months.
Adverse events that occurred among at least 20% of patients included in a safety analysis (n = 165) included pyrexia, cytokine release syndrome, musculoskeletal pain, injection site reaction, fatigue, upper respiratory tract infection, nausea, headache, pneumonia and diarrhea. The most common grade 3 or grade 4 laboratory abnormalities included decreased lymphocytes, decreased neutrophils, decreased white blood cells, decreased hemoglobin and decreased platelets.
"In the pivotal teclistamab study, we have continued to observe positive results in heavily pretreated patients with relapsed or refractory multiple myeloma," study investigator Ajai Chari, MD, professor of medicine in the division of hematology and medical oncology at Icahn School of Medicine at Mount Sinai, said in a press release. “As a clinician and researcher, I see firsthand the human toll of this incurable disease. 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 label includes a boxed warning noting teclistamab-cqyv can lead to life-threatening or fatal cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS).
Among patients who received teclistamab-cqyv at the recommended dose, 72% developed cytokine release syndrome, 57% developed neurologic toxicity and 6% developed ICANS.
“The recent FDA approval of teclistamab is another incredible milestone in the immunotherapy approach to treating blood cancers,” Lee Greenberger, PhD, chief scientific officer of The Leukemia & Lymphoma Society (LLS), told Healio. “This new treatment option has the potential to improve the outcome for patients with the most serious forms of multiple myeloma.”
Multiple myeloma has been "a primary focus of research" at The Leukemia & Lymphoma Society, with $26 million currently allocated to fund more than 30 active laboratory and clinical research projects, Greenberger said.
“[Although] we have made impressive progress in improving care for patients with multiple myeloma over the past 20 years, there is still more to learn about the disease," Greenberger told Healio. "Currently, LLS is focused on preventing pre-myeloma from advancing to myeloma, identifying mutations that cause the disease and understanding why patients become resistant to certain treatments.”
References:
- FDA. FDA approves teclistamab-cqyv for relapsed or refractory multiple myeloma [press release]. Oct. 25, 2022.
- Janssen. U.S. FDA Approves TECVAYLI (teclistamab-cqyv), the First Bispecific T-cell Engager Antibody for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma [press release]. Oct. 25, 2022.
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