J&J Snags FDA Approval for Second Multiple Myeloma Bispecific Antibody

Michael Vi/Getty Images, Mark Wildgust_Janssen Bio

Michael Vi/Getty Images, Mark Wildgust_Janssen Bio

Despite being heavily pretreated, patients on J&J’s Talvey saw a 73.6% overall response rate in a Phase II study, winning accelerated approval from the regulator.

Pictured: Janssen, a J&J Company/iStock, Michael Vi

Johnson & Johnson took the fast track for its latest cancer drug. J&J’s subsidiary Janssen Pharmaceutical announced Thursday its bispecific antibody has won accelerated approval from the FDA for relapsed or refractory multiple myeloma.

J&J’s first-in-class antibody Talvey (talquetamab-tgvs) is bispecific, binding to the CD3 receptor on the T cell surface to a receptor expressed on the myeloma cells to bring them together, allowing the body’s immune system to kill the cancer.

The accelerated approval was based on a Phase II study. An overall response rate of 73.6% was seen in patients with at least four prior lines of therapy, including a bispecific antibody or CAR-T cell therapy. Response was durable for a median of 9.5 months in the lower dosing group. Median duration of response was not yet reached in the higher dose arm.

“Patients at this stage of disease have a poor prognosis,” Ajai Chari, director of the multiple myeloma program at UCSF, said in a statement. Efficacy in this heavily treated population “has been notable,” he added.

Talvey will come with the FDA’s Boxed Warning due to risk of cytokine release syndrome and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome.

“Although options for the treatment of multiple myeloma have expanded significantly in recent years, the disease remains incurable, and therefore, patients are in need of new treatment options,” Michael Andreini, CEO of the Multiple Myeloma Research Foundation, said in a statement.

Patients with this chronic blood cancer run through a gambit of treatments over the years to extend life, knowing remission is coming eventually.

This is the second bispecific antibody for multiple myeloma to hit the market from J&J’s Janssen. Approved last fall, Tecvayli is also a fifth line, subcutaneous treatment that targets the same receptor on the T-cell and the BCMA expressed on the surface of the cancer cells.

Both drugs fall under a restricted program—Risk Evaluation and Mitigation Strategy (REMS)—which focuses on monitoring and counseling for patients. Even with the restrictions, analysts forecasted annual sales over $2 billion at the time of approval.

The company now has five multiple myeloma treatments on the market, with a goal of having “three out of every four [myeloma] patients starting in Janssen containing regimen by the end of this decade,” the J&J CEO Joaquin Duato said during a second-quarter earnings call last month.

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.