Pfizer's Elranatamab has been approved in China for the treatment of patients with multiple myeloma

According to the Zhitong Finance APP, on March 10, Pfizer Inc. (PFE.US) announced that the bispecific antibody new drug elranatamab (埃纳妥单抗) has officially received marketing approval in China, indicated for the treatment of adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least three lines of therapy (including a proteasome inhibitor, an immunomodulator, and an anti-CD38 monoclonal antibody). Elranatamab is a bispecific antibody that targets both BCMA and CD3, which received accelerated approval from the FDA in August 2023 for the treatment of relapsed/refractory MM patients.

According to Pfizer, elranatamab was approved based on clinically meaningful overall response rates and duration of response from the global pivotal phase 2 single-arm study MagnetisMM-3 and a separate phase 1b/2 single-arm study MagnetisMM-8 in China.

Data from the MagnetisMM-3 clinical study showed that with a median follow-up of 33.9 months, elranatamab monotherapy demonstrated deep and durable efficacy in triple-refractory RRMM patients, with the median duration of response (mDOR) not yet reached, a 30-month DOR rate of 61.0%, a median progression-free survival (PFS) of 17.2 months, and a median overall survival (OS) of 24.6 months, with no new safety signals observed.

Multiple myeloma (MM) is an incurable blood cancer. Most MM patients experience disease relapse or develop resistance to treatment, necessitating subsequent therapies. Furthermore, as the disease progresses, the aggressiveness of each relapse increases, while the duration of remission achieved with new therapies gradually shortens. BCMA is considered an ideal target for treating MM, as it is a member of the TNF receptor superfamily, primarily expressed in MM cell lines and cells from MM patients, with expression levels increasing as the disease progresses