Johnson & Johnson's First-in-Class Bispecific Antibody Talquetamab Nominated for Breakthrough Therapy Designation in China for Second-Line Relapsed/Refractory Multiple Myeloma

On June 1, the CDE official website announced that Johnson & Johnson’sTalquetamab（Talquetamab）ofAn application is proposed for inclusion in the Breakthrough Therapy designation, with the following indications: 1) Talquetamab + Daratumumab + Pomalidomide for second-line treatment of adult patients with relapsed or refractory multiple myeloma; 2) Talquetamab + Daratumumab for adult patients with relapsed or refractory multiple myeloma.Second-line treatment。

Source: CDEOfficial Website

Talquetamab is a first-in-class GPRC5D×CD3 bispecific antibody developed by Johnson & Johnson. It was first approved for marketing in the United States in August 2023, becoming the world’s first GPRC5D×CD3 bispecific antibody. Currently, the drug has been approved for marketing in the United States, the European Union, China, and Japan for the treatment of heavily pretreated multiple myeloma.In 2025, talquetamab generated $463 million in revenue, a year-on-year increase of 61.3%.。

Currently, Johnson & Johnson is still exploring the efficacy of talquetamab in treating patients with multiple myeloma at different stages. The indication proposed for inclusion as a breakthrough therapy is second-line treatment for relapsed/refractory multiple myeloma.

In May 2026, Johnson & Johnson was at the European Hematology Association（EHA）At the annual conference, Talquetamab + Daratumumab + Pomalidomide were announced. (Tal-DP) , Talquetumab + Daratumumab (Tal-D) Data from the Phase III MONUMENTAL-3 study evaluating second-line treatment for relapsed/refractory multiple myeloma. The control arm consisted of daratumumab plus pomalidomide and dexamethasone.（DPd）, with the primary endpoint being the Independent Review Committee（IRC）Progression-Free Survival Assessed（PFS）。

The median follow-up time was 24.6 months, and compared with the DPd regimen, both the Tal-DP and Tal-D regimens significantly improved PFS. In terms of the 24-month PFS rate,The Tal-DP group was 81.3%, and the Tal-D group was 77.6%, both superior to the control group.（51.2%）. The PFS benefit was consistent across all clinically relevant subgroups.

Objective Response Rate (ORR) In terms of response rate, the Tal-DP group was 88.2%, the Tal-D group was 88.5%, and the control group was 77.6%; in terms of CR rate, the Tal-DP group was 71.1%, the Tal-D group was 69.0%, and the control group was 34.5%; minimal residual disease（MRD）Negative Rate（≥CR）In terms of response rate, the Tal-DP group was 52.3%, the Tal-D group was 46.3%, and the control group was 15.9%. Compared with the control group, the hazard ratio for overall survival in the Tal-DP group was 0.47, and that in the Tal-D group was 0.51.

As of the data cutoff, 70.3%, 69.7%, and 47.3% of patients in the Tal-DP, Tal-D, and DPd groups, respectively, were still receiving study treatment. Adverse events were manageable and consistent with the expected profiles of the respective drugs.

In summary, the study concluded that, compared with the control group, both Tal-DP and Tal-D demonstrated significant and profound progression-free survival benefits, clinically meaningful improvements in overall survival, and incidence rates of grade ≥3 infections that were similar to or lower than those in the control group.

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