Janssen Submits BLA for Another Bispecific Antibody for Multiple Myeloma

Janssen Pharmaceuticals has submitted to the FDA a biologics license application (BLA) for talquetamab to treat patients with relapsed or refractory multiple myeloma. Talquetamab is a bispecific antibody that targets both CD3 receptor on T cells and GPRC5D, which is overexpressed on myeloma cells. Multiple myeloma is an incurable blood cancer that affects plasma cells, which are found in the bone marrow. In 2022, it is estimated that more than 34,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the United States.

Peter Lebowitz, M.D.

“Despite the therapies that have been developed for the treatment of multiple myeloma, there remains persistent unmet needs for patients who relapse or become refractory,” Peter Lebowitz, M.D., Ph.D., global therapeutic area head, oncology, Janssen Research & Development, said in a press release.

This BLA is supported by data from the phase 1/2, MonumenTAL-1 study of talquetamab in patients with relapsed or refractory multiple myeloma who have received more than three prior lines of therapy. The first presentation of phase 1/ 2 combined results from the MonumenTAL-1 study will be highlighted at the American Society of Hematology (ASH) Annual Meeting on December 10, 2022.

As of May 16, 2022, 288 patients with no prior exposure to T-cell redirecting therapies received talquetamab. In 143 patients treated with the 0.4 mg/kg dose weekly, overall response rate was 73%. Responses were durable and deepened over time. Median time to response was 1.2 months. Median time to complete response was 2.1 months. Median duration of response was 9.3 months, and median progression free survival was 7.5 months.

The most common adverse events were dysgeusia (impaired taste), anemia, skin-related adverse events and nail disorders, as well as cytopenias, including neutropenia, and thrombocytopenia, which were limited to the first few cycles. There were 2 deaths due to COVID-19.

The FDA granted breakthrough therapy designation to talquetamab in June 2022 for the treatment of adult patients with relapsed or refractory multiple myeloma and orphan drug designation in May 2021.

Related: FDA Approves First Bispecific Antibody for Multiple Myeloma

In October, the FDA approved the first bispecific antibody for multiple myeloma with a different target. Janssen’s Tecvayli (teclistamab-cqyv) to treat adult patients with relapsed or refractory multiple myeloma. It is an off-the-shelf therapy that targets the CD3 receptor expressed on the surface of T-cells and the B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells.