Pfizer's BCMA/CD3 Bispecific Antibody Elranatamab Granted Clinical Trial Approval in China for Multiple Myeloma

ByMedView

The CDE website of China's National Medical Products Administration (NMPA) shows that elranatamab, submitted by Pfizer, has received an implied permission for a clinical trial. The proposed indication is as follows: as a single agent or in combination with daratumumab for patients with multiple myeloma who have previously received at least one line of anti-multiple myeloma treatment (including lenalidomide and proteasome inhibitors). Public data shows that elranatamab is a bispecific antibody drug targeting BCMA and CD3, which has entered Phase 3 clinical research globally.

Source of the image: Screenshot from the CDE official website

B-cell Maturation Antigen (BCMA) is a member of the TNF receptor superfamily, primarily expressed in multiple myeloma cell lines and cells from patients with multiple myeloma. Its expression increases with disease progression, making it an ideal target for treating multiple myeloma.

According to previously disclosed information from Pfizer, elranatamab (PF-06863135) is a subcutaneously injectable bispecific antibody targeting BCMA and CD3. One end binds to BCMA, while the other end binds to the CD3 receptor on the surface of T cells, thereby activating T cells to kill cancer cells expressing BCMA.

Previously, elranatamab demonstrated its safety and high response rate in treating multiple myeloma in a phase 1 clinical trial involving patients with relapsed/refractory multiple myeloma. Among patients receiving a weekly dose of 1000 μg/kg, 83% achieved a response. Additionally, the safety of all subcutaneous injection doses was manageable, with no dose-limiting toxicity observed. In January 2021, elranatamab received Fast Track designation from the U.S. FDA for the treatment of relapsed/refractory multiple myeloma.

▲Introduction to elranatamab (Image Source: Pfizer's official website)

ClinicalTrials官网显示，目前elranatamab正在针对多发性骨髓瘤患者开展多项2期或3期临床研究。其中，一项名为MagnetisMM-5的3期临床研究已经于2021年8月开始进行，该研究将评估elranatamab单药或联合达雷妥尤单抗注射液，对既往接受过至少1线抗多发性骨髓瘤治疗（包括来那度胺和蛋白酶体抑制剂）的复发/难治性多发性骨髓瘤患者的疗效和安全性。

In China, elranatamab has previously received an implied permission for a clinical trial. Currently, this product is undergoing a Phase 1b/2 open-label study in triple-refractory multiple myeloma patients to evaluate safety, pharmacokinetics, pharmacodynamics, and efficacy.

References:

[1] Website of the Center for Drug Evaluation, National Medical Products Administration of China - Clinical Trial Implied Permission. Retrieved Jan 19, 2022, from https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] Oncology. Retrieved February 2, 2021, from https://s21.q4cdn.com/317678438/files/doc_presentations/2020/09/Oncology_FINAL.pdf

[3] Pfizer Initiates Pivotal Phase 2 MagnetisMM-3 Trial of BCMA-CD3 Bispecific Antibody Elranatamab (PF-06863135) in Multiple Myeloma. Retrieved Feb 17,2021,from https://www.pfizer.com/news/press-release/press-release-detail/pfizer-initiates-pivotal-phase-2-magnetismm-3-trial-bcma

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