AstraZeneca's CD20×TCR×CD8 Trispecific Antibody AZD5492 Granted Clinical Trial Approval in China for Relapsed or Refractory B-cell Malignancies

According to the CDE official website, AstraZeneca's Class 1 new drug AZD5492 has received clinical trial approval for the treatment of relapsed or refractory B-cell malignancies. Public information indicates that this drug is a CD20×TCR×CD8 trispecific antibody.

Source of the image: CDE official website

Targeting B-Cell Disorders
Overseas Clinical Trials Have Been Initiated

B-cell malignancies are malignant diseases originating from B lymphocytes, of which about 3/4 are lymphomas, mainly divided into precursor B-cell tumors and mature B-cell tumors. Studies show that when B cells undergo abnormal proliferation and uncontrolled differentiation, B-cell malignancies may develop.

AZD5492 is a CD20×TCR×CD8 trispecific antibody developed by AstraZeneca for the treatment of B-cell-related diseases. At the 2024 EHA Annual Meeting held in June this year, AstraZeneca presented preclinical research data on AZD5492 for B-cell non-Hodgkin lymphoma. Relevant studies have shown that AZD5492 has the potential to significantly improve the treatment outcomes of B-cell lymphoma.

Image Source: AstraZeneca

In September, AstraZeneca initiated a Phase I/II clinical study of AZD5492, which is expected to enroll 174 participants and is scheduled for completion on February 16, 2028.

Image Source: clinicaltrials.gov

The clinical trial application for AZD5492 has successfully obtained approval from the CDE, and AstraZeneca may further its research in China.

Comprehensive Tumor Pipeline Layout
Clinical Research Accelerates Further

AstraZeneca has a globally leading advantage in the oncology field, particularly in the lung cancer treatment sector, where it already possesses three commercialized varieties: targeted therapy, immunotherapy, and ADC. At the same time, AstraZeneca has comprehensively laid out its subsequent pipeline in oncology, and since 2024, several of its studies have made new progress.

Image Source: AstraZeneca

Trastuzumab Deruxtecan

Trastuzumab Deruxtecan, a HER2 ADC drug jointly developed by AstraZeneca and Daiichi Sankyo, was approved for the first time in China in February 2023. On October 9, trastuzumab deruxtecan for injection received conditional approval from the NMPA for adult patients with unresectable locally advanced or metastatic non-small cell lung cancer harboring HER2 (ERBB2) activating mutations who have previously received at least one systemic therapy. This drug has become the first and only ADC drug approved in China for the treatment of HER2-mutated advanced non-small cell lung cancer.

Calquence

Calquence, a BTK inhibitor developed by AstraZeneca, has previously been approved by the U.S. FDA for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy, as well as adult patients with chronic lymphocytic leukemia and small lymphocytic lymphoma. On October 4, AstraZeneca announced that the supplemental New Drug Application for Calquence had been accepted by the FDA and granted Priority Review designation for the treatment of previously untreated adult patients with mantle cell lymphoma.

AZD5335

AZD5335 is an FRα ADC developed by AstraZeneca. At the 2024 ESMO Congress held in September, data on platinum-resistant recurrent ovarian cancer for AZD5335 was presented, showing responses observed at all dose levels of AZD5335. AstraZeneca believes that AZD5335 may be more effective than Elahere, which targets the same FRα, in patients with low FRα expression.

AZD8205

AZD8205 is a B7-H4 ADC drug developed by AstraZeneca based on its proprietary TOP1i platform. The target has limited expression in normal tissues but is overexpressed in various tumors, including endometrial cancer, ovarian cancer, breast cancer, and cholangiocarcinoma. At this year's ESMO Congress, AstraZeneca presented the clinical study results of AZD8205, which showed that the drug has manageable safety and potential for treating patients with advanced or metastatic solid tumors.

In addition, AstraZeneca's early pipeline includes several highly promising drugs, such as the CD19/CD3 bispecific antibody "AZD0486," the PRMT5 inhibitor "AZD3470," and the BCMA/CD19 dual-target FaSTCAR-T "AZD0120" acquired through the purchase of Gracell Biotechnologies……

Conclusion

Apart from the anti-tumor field, AstraZeneca's presence in areas such as cardiovascular, renal, and metabolic diseases is also continuously expanding. At the same time, AstraZeneca's innovative pipeline layout in China is deepening, including the successful acquisition of Gracell Biotechnologies in February, and the development of Shanghai as its fifth global strategic center.

Editor: Mu Mian

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