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Today (October 14), the official website of China's National Medical Products Administration (NMPA) information display shows that, by Daiichi Sankyo（Daiichi Sankyo）DeclaredTrastuzumab Deruxtecan for Injection (Enhertu, Yohoget) New Indication for Lung CancerHas already received marketing approval. According to the earlier priority review information disclosure, the indication approved this time is: for the treatment ofExistHER2 Adult patients with non-small cell lung cancer (NSCLC) who have activating mutations and have previously received at least one systemic therapy, and whose disease is unresectable or metastatic.
Image Source: Screenshot from the NMPA official website
Trastuzumab deruxtecan (English trade name: Enhertu) isA HER2-targeted antibody-drug conjugate (ADC), jointly developed by AstraZeneca and Daiichi Sankyo.HER2 is a tyrosine kinase receptor pro-growth protein expressed on the surface of various tumor cells, including lung cancer, breast cancer, gastric cancer, and colorectal cancer.As a HER2-targeted ADC, trastuzumab deruxtecan is composed of a humanized monoclonal antibody targeting HER2 linked to a topoisomerase I inhibitor (DXd, a camptothecin derivative) payload through a tetrapeptide cleavable linker.
Currently, trastuzumab deruxtecan has been approved for marketing in multiple countries and regions worldwide for various indications, including breast cancer, lung cancer, gastric cancer, and solid tumors. In the field of lung cancer treatment, in August 2022, the U.S. FDA granted accelerated approval for Enhertu to expand its indication for the treatment of patients with activatingHER2Patients with unresectable or metastatic NSCLC harboring mutations. In April 2024, Trastuzumab Deruxtecan received FDA approval."Tumor-Agnostic" Indication, for previously treated, unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumors in adult patients. Previous press releases noted,Enhertu is the first HER2-targeted ADC therapy with an indication that is not limited to specific cancer types.In China, the product has been previously approved for the treatment ofHER2 Positive andHER2 Low-expression adult breast cancer patients. Previously, it had been included multiple times by the CDE.Breakthrough Therapy Drug, Indications includeHER2-Positive Breast Cancer、HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma、Non-small cell lung cancer with activating HER2 mutations, etc.In February 2024, the marketing application for Trastuzumab Deruxtecan for the treatment of NSCLC with HER2 activating mutations was accepted by the CDE and included.Priority Review。In the field of lung cancer treatment, the previous DESTINY-Lung02 trial demonstrated that trastuzumab deruxtecan showed efficacy in previously treated patients.HER2 Mutated NSCLC patients can achieve a high remission rate with controllable safety. However, the DESTINY-Lung02 trial has not yet covered Chinese patients.AndResearch Data on Treatment for Lung Cancer Patients in China to be Revealed in April 2024, that isDESTINY-Lung05 Trial。This is an open-label, single-arm, Phase 2 trial. As of the data cutoff date (September 23, 2023), a total of72 patientsHER2-Mutated NSCLC Patients Received Trastuzumab Deruxtecan.
The study results showed that, in previously treated HER2-mutant NSCLC patients in China,Objective Response Rate (ORR) Nearly 60%, Disease Control Rate (DCR) Exceeds 91%。The median drug exposure time for patients was 7.9 months, and the median follow-up time was 9.8 months.Multiple efficacy endpoints show that trastuzumab deruxtecan brings clinically meaningful and durable relief. Moreover,The safety is controllable and consistent with the known safety profile.Overall, the DESTINY-Lung05 trial data support the use of trastuzumab deruxtecan in previously treated HER2-mutant NSCLC patients in China.The approval of trastuzumab deruxtecan for lung cancer treatment in China this time willHER2 New Treatment Options for Lung Cancer Patients with Mutations.References:
[1] Drug Approval Certificate Delivery Information on October 14, 2024. From https://www.nmpa.gov.cn/zwfw/sdxx/sdxxyp/yppjfb/20241014141010193.html
[2] CT248 / 7 - Trastuzumab deruxtecan (T-DXd) in Chinese patients (pts) with previously treated HER2 mutant non-small cell lung cancer (NSCLC): primary analysis from the Phase 2 DESTINY-Lung05 (DL-05) trial. Retrieved April 8, 2024 from https://www.abstractsonline.com/pp8/#!/20272/presentation/11569
[3] FDA grants accelerated approval to fam-trastuzumab deruxtecan-nxki for unresectable or metastatic HER2-positive solid tumors. Retrieved April 5, 2024 from https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-fam-trastuzumab-deruxtecan-nxki-unresectable-or-metastatic-her2
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