FDA approves Talvey for heavily pretreated multiple myeloma
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The FDA granted accelerated approval to talquetamab-tgvs for treatment of certain patients with relapsed or refractory multiple myeloma.
The indication authorizes use of the agent for adults who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent and an anti-CD38 antibody.
Talquetamab-tgvs (Talvey, Janssen) — administered as a weekly or biweekly subcutaneous injection — is a first-in-class bispecific antibody. It binds to the CD3 receptor on the surface of T cells and G protein-coupled receptor class C group 5 member D on the surface of multiple myeloma cells, nonmalignant plasma cells and healthy tissue, according to a Janssen press release.
The FDA granted accelerated approval based on response rate and response durability observed with the agent.
The phase 2 MonumenTAL-1 study included 187 patients who received at least four prior lines of therapy and who were not exposed to prior T-cell redirection therapy.
Researchers reported ORRs of 73.6% among patients treated at 0.8 mg/kg biweekly and 73% among those treated at 0.4 mg/kg weekly. Median duration of response had not been reached in the 0.8 mg/kg biweekly group and was 9.5 months for those treated at 0.4 mg/kg weekly.
“The clinically meaningful efficacy and safety profile observed with talquetamab in heavily pretreated patients in this clinical trial, which included patients treated with prior BCMA-targeted bispecific or [chimeric antigen receptor] T-cell therapy, has been notable,” Ajai Chari, MD, director of the multiple myeloma program at University of California, San Francisco, said in a Janssen-issued press release. “Patients at this stage of disease have a poor prognosis. Talquetamab as a first-in-class therapy is a new option for patients with this difficult-to-treat blood cancer.”
The label for talquetamab includes a boxed warning for cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome.
The most common adverse reactions reported among at least 20% of patients treated with the therapy included pyrexia, CRS, dysgeusia, nail disorder, musculoskeletal pain, skin disorder, rash, fatigue, weight decrease, dry mouth, xerosis, dysphagia, upper respiratory tract infection, diarrhea, hypotension and headache.
The most common grade 3 or grade 4 laboratory abnormalities included decreases in lymphocyte count, neutrophil count, white blood cell count and hemoglobin.
Continued approval for this indication will be contingent on confirmation of clinical benefit in a confirmatory trial.
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