Janssen myeloma drug approved in US via a restricted programme

FDA

The FDA has granted accelerated approval to Janssen’s talquetamab-tgvs (Talvey) for adults with relapsed or refractory multiple myeloma.

It has been approved in patients who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

Talquetamab is a bispecific T cell engaging antibody that binds to the CD3 receptor on the surface of T cells and G protein-coupled receptor class C group 5 member D (GPRC5D) expressed on the surface of multiple myeloma cells.

It showed an overall response rate of more than 70% with durable responses, including in patients previously treated with a bispecific antibody or CAR-T cell therapy.

“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 CAR-T cell therapy, has been notable,” said Ajai Chari, Director of Multiple Myeloma Program, Professor of Clinical Medicine at the University of California, San Francisco. “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.”

Talquetamab is only available through a restricted programme called the Tecvayli-Talvey Risk Evaluation and Mitigation Strategy (REMS), due to the risk of cytokine release syndrome (CRS) and neurologic toxicity.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended conditional marketing authorisation for talquetamab in July.

Results of the MonumenTAL-1 study

In the Phase II MonumenTAL-1 study, 73.6% of patients achieved an overall response rate (ORR) at the SC biweekly dose of 0.8mg/kg. With a median follow-up of nearly six months from first response among responders, 58% of patients achieved a very good partial response (VGPR) or better, including 33% of patients achieving a complete response (CR) or better.

At the SC weekly dose of 0.4mg/kg, 73% of patients achieved an ORR. With a median follow-up of nearly 14 months from first response among responders, 57% of patients achieved a VGPR or better, including 35% of patients achieving a CR or better. Among patients receiving the 0.8mg/kg SC biweekly dose, an estimated 85% of responders maintained response for at least nine months.

Of patients who were exposed to prior bispecific antibody or CAR-T cell therapy and had received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, 72% achieved an ORR and an estimated 59% of responders maintained response for at least nine months.

Edited by Diana Spencer, Senior Digital Content Editor, Drug Discovery World

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