Pfizer's Bispecific Antibody Elranatamab Approved in China for Relapsed/Refractory Multiple Myeloma, Narrowly Missing First-in-Class Status

On March 10, Pfizer announced a new bispecific antibody drugelranatamab (Enatuzumab)Officially received approval for marketing in China, applicable toTreatment 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 immunomodulatory agent, and an anti-CD38 monoclonal antibody)Elnatuzumab is a bispecific antibody that simultaneously targets BCMA and CD3. It received accelerated FDA approval in August 2023 for the treatment of relapsed/refractory MM patients.

Eflapegrastim was approved based on the clinically meaningful overall response rate and duration of response from the global pivotal Phase 2 single-arm study MagnetisMM-3 and the separate Phase 1b/2 single-arm study MagnetisMM-8 conducted in China. Data from the MagnetisMM-3 clinical study showed that, with a median follow-up of 33.9 months, eflapegrastim monotherapy continued to demonstrate deep and durable efficacy in triple-class refractory RRMM patients, with the median duration of response (mDOR) not yet reached.The 30-month DOR rate was 61.0%, the median progression-free survival (PFS) was 17.2 months, and the median overall survival (OS) was 24.6 months.And no new safety signals were observed.

Multiple Myeloma (MM) is an incurable blood cancer. Multiple Myeloma (MM) is a malignant disease characterized by the abnormal proliferation of clonal plasma cells and is the second most common hematologic malignancy in many countries.

Despite the widespread use of numerous new drugs (proteasome inhibitors, immunomodulatory agents, monoclonal antibodies, etc.) and autologous stem cell transplantation in the first-line treatment of MM, MM remains an incurable disease to date. Almost all patients will experience a relapsed/refractory phase, and the diagnosis and treatment of such patients remain a clinical challenge.

BCMA is considered an ideal target for the treatment of MM,It is a member of the TNF receptor superfamily, primarily expressed in MM cell lines and cells of MM patients, with expression increasing as the disease progresses.

Regrettably, Pfizer's Enoticumab is the second bispecific antibody targeting BCMA, while the first approved bispecific antibody targeting BCMA is Johnson & Johnson's Talquetamab.It is also the First-in-Class drug for this target. Talquetamab was granted accelerated approval by the U.S. FDA on August 9, 2023, and is expected to receive NMPA approval on February 11, 2025, for the treatment of relapsed or refractory multiple myeloma (RRMM). Talquetamab is a First-in-Class therapy that works by binding to the CD3 receptor on T cells and GPRC5D on multiple myeloma cells, directing T cells to specifically kill tumor cells expressing GPRC5D.

January,Sanofi's anti-CD38 monoclonal antibody drug Isatuximab has been approved by China's National Medical Products Administration (NMPA)., used for the treatment of multiple myeloma. Isatuximab works by specifically binding to CD38 on the surface of multiple myeloma cells, triggering multiple mechanisms of action, including induction of tumor cell apoptosis, modulation of immune response, promotion of antibody-dependent cellular cytotoxicity (ADCC), and complement-dependent cytotoxicity (CDC), effectively killing tumor cells.

Comparison of 3 Drugs, Source: Sina Medicine

Although MM currently remains incurable, with the increase in treatment lines and shorter remission periods, using more effective drugs earlier on is expected to delay disease progression.

Editor of this article: Zhang Jie