AstraZeneca's ADC + Bispecific Antibody Combination Therapy Granted IND Approval in China for First-Line Treatment of HER2-Expressing Biliary Tract Cancer

Dec 06, 2024 10:09 CST Updated 10:09

AstraZeneca

Biopharmaceutical Manufacturer

▎WuXi AppTec Content Team Report

On December 5, the latest announcement on the official website of the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) showed,AZD2936 and DS-8201a, two new drugs applied for by AstraZeneca, have simultaneously received implied clinical trial approval, with indications forFirst-line treatment for patients with locally advanced or metastatic HER2-expressing biliary tract cancer。

Public information shows that DS-8201a (i.e., Trastuzumab Deruxtecan for Injection, Enhertu) is jointly developed by AstraZeneca and Daiichi Sankyo.Antibody-Drug Conjugates (ADC) Targeting HER2; AZD2936 (rilvegostomig) is aBispecific Antibody Targeting PD-1/TIGITAstraZeneca is conducting a global Phase 3 clinical trial (DESTINY-BTC01) to explore the combination therapy of Enhertu + rilvegostomig as a first-line treatment for HER2-positive biliary tract cancer. This is also the indication for which the combination therapy was approved for clinical use in China.

Screenshot source: CDE official website

RilvegostomigIt is a bispecific antibody that can simultaneously target PD-1 and TIGIT.TIGIT is an immune checkpoint protein primarily expressed on the surface of T cells and natural killer cells (NK cells), and its role in tumor immune suppression is similar to that of PD-1/PD-L1.. Studies have found that blocking the immunosuppression caused by the binding of TIGIT to its ligand can relieve the suppression and exhaustion of T cells and NK cells, thereby promoting the anti-tumor effects mediated by T cells and NK cells.。

According to the pipeline information on AstraZeneca's official website, the company is currently exploring in multiple Phase III clinical studies.rilvegostomigThe efficacy, in addition to targeting biliary tract cancerDESTINY-BTC01 Study, as well as monotherapy forAdjuvant therapy for biliary tract cancer, monotherapy for first-line treatment of non-small cell lung cancer, and the combination therapy of rilvegostomig with TROP2-targeted ADC for non-small cell lung cancer (TROPION-Lung12) are all in Phase 3 clinical research.

Enhertu is a HER2-targeted ADC,Composed of a humanized monoclonal antibody targeting HER2 linked to a topoisomerase 1 inhibitor (DXd, a camptothecin derivative) payload through a cleavable tetrapeptide linker.. CurrentlyEnhertuMultiple indications have been approved for marketing in numerous countries and regions worldwide, including breast cancer, lung cancer, gastric cancer, and solid tumors.

DESTINY-BTC01 is an international multi-center Phase 3 clinical study designed to evaluateEnhertuEfficacy and Safety of Rilvegostomig Combination Therapy vs. SoC (Gemcitabine, Cisplatin, and Durvalumab) in Advanced HER2-Expressing Biliary Tract Cancer. This study was initiated in August 2024 and plans to enroll 620 participants globally.

We look forward to the smooth progress of the follow-up research on the combination therapy of this ADC and bispecific antibody, which will bring better treatment options to patients as soon as possible.

References:

[1]Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China. Retrieved Dec 5, 2024, fromhttps://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c

[2] AstraZeneca Official Website. From https://www.astrazeneca.com/our-therapy-areas/pipeline.html

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