Daiichi Sankyo and AstraZeneca’s Trastuzumab Deruxtecan Approved in China for HER2-Mutant NSCLC
Daiichi-Sankyo
Pharmaceutical R&D Developer
AstraZeneca
Biopharmaceutical Manufacturer
On October 14, the NMPA website showed that the trastuzumab deruxtecan developed jointly by Daiichi Sankyo and AstraZeneca（Enhertu）Approved for new indications in China,For the treatment of adult patients with unresectable or metastatic non-small cell lung cancer who have HER2 activating mutations and have received at least one prior systemic therapy. (NSCLC)（JXSS2400013）。
Screenshot source: NMPA official website
This is the approval of Trastuzumab Deruxtecan in China.The Fourth Indication, which has previously been approved for three indications in China:
Monotherapy for previously treated with one or more anti-HER2 therapies, unresectable or metastaticHER2-Positive Adult Breast Cancer（2023/02）；
Monotherapy for patients who have previously received at least one systemic therapy in the metastatic disease stage, or who relapsed during or within 6 months after completing adjuvant chemotherapy, with unresectable or metastatic disease.HER2 Low-Expression Adult Breast Cancer（2023/07）；
Monotherapy for patients with locally advanced or metastatic disease who have previously received two or more treatment regimensHER2-Positive Adult Gastric or Gastroesophageal Junction Adenocarcinoma（2024/08）。
The approval of Trastuzumab Deruxtecan in China this time is based onDESTINY-Lung05 Study. This study aims to evaluateTrastuzumab DeruxtecanEfficacy and Safety of Trastuzumab Deruxtecan in Chinese Patients with Previously Treated HER2-Mutant Metastatic NSCLC.
Presented at the 2024 AACRResearchThe research data shows:
As of September 23, 2023, a total of 72 patients had received treatment with trastuzumab deruxtecan (5.4 mg/kg Q3W).As confirmed by ICR evaluationORR was 58.3%, DCR was 91.7%, mPFS has not been reached, and the 12-month PFS rate is 53.1%.
In terms of safety, the safety of Trastuzumab Deruxtecan is controllable. The incidence of drug-related interstitial lung disease/pneumonia is only 9.7%, mostly low-grade, and the proportion of patients discontinuing the drug due to drug-related adverse reactions is only 2.8%.
Data from the DESTINY-Lung05 study confirmed the efficacy and safety of trastuzumab deruxtecan in Chinese patients with previously treated HER2-mutated metastatic NSCLC.This approval will fill the gap for Chinese patients with previously treated HER2-mutated metastatic NSCLC who have no targeted therapy drugs available.。
Screenshot source:Insight Database
