FDA Approves Talquetamab-Tgvs For Adults with Relapsed Or Refractory Multiple Myeloma Patients with at least Four Prior Lines of Therapy

By Dr. Anish Shah

Bronx Lebanon Hospital

 

On August 9, 2023, the U.S. Food and Drug Administration approved talquetamab-tgvs (Talvey, Janssen Biotech, Inc.) for adults with multiple myeloma with relapsed or refractory disease that has not responded to at least four prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 monoclonal antibody.

 

Study ID number: NCT03399799

 

Approval was based on the MonumenTAL-1 study, a single-arm, open-label, multicenter study that included 187 patients with relapsed or refractory multiple myeloma meeting the specified inclusion criteria. Talquetamab-tgvs was administered subcutaneously either as 0.4 mg/kg weekly, following two step-up doses in the first week, or as 0.8 mg/kg biweekly, following three step-up doses, until disease progression or unacceptable toxicity.

 

Efficacy was established by measuring overall response rate (ORR) and duration of response (DOR). The ORR in 100 patients receiving 0.4 mg/kg weekly was 73% (95% CI: 63.2%, 81.4%) with a median DOR of 9.5 months (95% CI: 6.5, not estimable). Likewise, ORR in 87 patients receiving 0.8 mg/kg biweekly was 73.6% (95% CI: 63%, 82.4%) with a median DOR that was not estimable. About 85% of responders maintained a response for at least nine months.

 

The prescribing information included a boxed warning for life-threatening or fatal cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity (ICANS). Other common adverse reactions (≥ 20%) include dysgeusia, nail disorder, skin disorder, rash, myalgia, fatigue, weight loss, xerostomia, xerosis, dysphagia, pyrexia, upper respiratory tract infection, and diarrhea, among others.

 

The FDA approved talquetamab-tgvs for adults with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy. The recommended doses are either 0.4 mg/kg weekly or 0.8 mg/kg biweekly subcutaneously. The drug comes with a Boxed Warning due to the risks of CRS and neurologic toxicity.