Pfizer's Elranatamab Approved in China, Marking Major Entry into the Multi-Billion-Dollar Multiple Myeloma Market

Recently, Pfizer's subcutaneously injectable CD3/BCMA bispecific antibodyEnatuzumabApproved by the China National Medical Products Administration (NMPA) for marketing, intended for adult patients with relapsed or refractory multiple myeloma (RRMM) who have previously received at least three lines of therapy. This follows the approval of Johnson & Johnson's Teclistamab.The Second ClauseTargeting CD3/BCMA bispecific antibody approved by NMPA.

Thus, with the entry of pharmaceutical giants such as Johnson & Johnson and Pfizer, multiple myeloma in China...Bispecific Antibody FieldTirabrutinib, Taqutotumab, and Enadotinib Have Already Made a Brilliant Debut.

▍Pfizer Makes a Strong Entry

Egnatunumab is a subcutaneously injectable, fixed-dose bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3. It can bind to the BCMA antigen on myeloma cells and the CD3 receptor on T cells, constructing an "artificial immune synapse" to activate endogenous T cells for precise tumor cell killing.

The approval of Enfortumab is based on the global pivotal Phase II single-arm study.MagnetisMM-3And a separate single-arm Phase Ib/II study in ChinaMagnetisMM-8。

MagnetisMM-3 is an open-label, multi-center, non-randomized Phase II study. In 2024, Pfizer presented its clinical research data at the ASH Annual Meeting, showing that,Median follow-up of 33.9 monthsEnaptumab monotherapy continues to demonstrate deep and durable efficacy in triple-refractory RRMM patients. The median duration of response (mDOR) has not yet been reached, with a 30-month DOR rate of 61.0%. The median progression-free survival (PFS) is 17.2 months, and the median overall survival (OS) is 24.6 months. No new safety signals were observed.

MagnetisMM-3 Clinical Study Data / Data Source: 2024 ASH. Abstract 4738

Based on the results of the MagnetisMM-3 study, Elranatamab was approved in August 2023.U.S. FDAAccelerated approval for the treatment of patients who have previously receivedAt Least Four-Line TreatmentAdult patients with relapsed or refractory multiple myeloma. December 2023,European CommissionEnertumab has been granted conditional marketing authorization for single-agent use in the treatment of patients who have previously receivedAt least three treatments, and adult patients with relapsed or refractory multiple myeloma who have disease progression after their last treatment.

Currently, Enatuzumab has been granted marketing authorization in multiple countries and regions worldwide, and has received recognition from the National Comprehensive Cancer Network (NCCN) in the United States.Recommended by authoritative guidelines such as the NCCN。

The approval of Elnatuzumab not only marks Pfizer's successful entry into the billion-dollar multiple myeloma treatment market but also heralds the shift in multiple myeloma treatment from traditional chemotherapy and targeted therapy to a new era.Precision ImmunotherapyA new phase.

▍A百亿市场，谁与争锋？

Global Multiple Myeloma Market SizeMore than 20 billion US dollars, in the past, the market share has always been held byDrugs such as Daratumumab, Lenalidomide, and Pomalidomide occupy.

2015-2023 Global Multiple Myeloma Key Drug Market Size / Data Source: Southwest Securities Research Report

Among them, targeting CD38Daratumumab is the biggest beneficiary in the market.By 2023, the total sales had reached $9.7 billion, and in 2024, it broke through the $10 billion mark, with total sales reaching$11.6 billion

The drug was approved for marketing by the FDA in 2015, and subsequently received approval in the European Union, Canada, Japan, Australia, and China. It has now secured applications in multiple scenarios, ranging from monotherapy in later lines to first-line treatment.

Among them,Significant Advantages in First-Line Treatment, leading a new pattern in the first-line treatment of multiple myeloma.

In addition,Lenalidomide, PomalidomideRepresentative immunomodulatory drugs (IMiDs) also occupy a certain market share.

▍Accelerate Progress with BCMA as the Core

Due to the clonal evolution of tumor cells and the suppressive nature of the immune microenvironment, the treatment of multiple myelomaFacing Multiline Recurrence and Drug ResistanceCurrently, significant progress has been made in immunotherapy with BCMA-targeted drugs, which are considered a powerful tool to overcome the immunosuppressive microenvironment and promote anti-tumor immune responses, with the unique potential to induce immune memory and reduce the risk of recurrence.

Currently, globally, there are already7 ProductsBCMA-Targeted Drug for the Treatment of Multiple Myeloma Launched.

Among them,CAR-T ProductsFour products have been approved for marketing. Globally, the product from BMS has been approved for marketing.idecabtagene vicleucelAnd Johnson & Johnson/Legend Biotech'sCilta-celAmong them, the global sales of Cilta-cel in 2024 are approaching 1 billion US dollars.

The domestically approved and marketed products include those jointly developed by Icarus Bio and Innovent Biologics.Idecabtagene VicleucelAnd Caris Biotechnology/Huadong MedicineZevorcel。

Globally marketed BCMA-targeted drugs for the treatment of multiple myeloma / Data source: PharmCube, Yaochuang Innovation Table

Notably, in April 2024Cilta-celMultiple MyelomaSecond-lineTreatment Approved, This IsThe world's first and onlyCAR-T Product Approved for Second-Line Treatment of Multiple Myeloma.

Currently globally approved and marketedBispecific Antibody ProductsThere is Johnson & Johnson'sTelituximab(Teclistama, approved for marketing in 2022) and Pfizer'sEnatuzumab(Elranatamab, approved for marketing in 2023) both target BCMA/CD3. Currently, these two drugs have been approved for marketing in China.

In addition, globally approvedADC ProductsOnly one, from GSK.Maribavir。

The revolution in multiple myeloma treatment is accelerating with BCMA-targeted therapies at its core. Breakthroughs in immunotherapy approaches such as CAR-T, bispecific antibodies, and ADCs not only provide new strategies for overcoming tumor clonal heterogeneity and the immunosuppressive microenvironment but also significantly reduce the risk of recurrence by inducing deep remission and immune memory.

▍Conclusion

In the competition within the billion-dollar market, traditional drugs still dominate, but the "long-tail effect" of immunotherapy has begun to emerge. The treatment of multiple myeloma is moving from "prolonging survival" towards "functional cure." This revolution, sparked by the BCMA target, will ultimately redefine the boundaries of cancer immunotherapy.

Source: Medical Circle

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