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Enhertu recommended in EU for HER2-mutant NSCLC
Enhertu recommended in EU for HER2-mutant NSCLC.
About this update from Astrazeneca Plc
[{"type":"text","content":"\n\n15 September 2023\nEnhertu recommended for approval in the EU by CHMP for\npatients with HER2-mutant advanced non-small cell lung cancer\nRecommendation based on DESTINY-Lung02 trial results which showed AstraZeneca and Daiichi Sankyo's Enhertu achieved strong and durable tumour responses in previously treated HER2-mutant disease\n \nEnhertu showed a confirmed objective response rate of 49% and median duration of response of 16.8 months\n \nAstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.\n \nEnhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.\n \nThe Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency based its positive opinion on the primary results from the DESTINY-Lung02 Phase II trial, which were presented at the IASLC 2023 World Conference on Lung Cancer and simultaneously published in the Journal of Clinical Oncology.\n \nIn the trial, Enhertu (5.4mg/kg) demonstrated a confirmed objective response rate (ORR) of 49.0% (95% confidence interval [CI] 39.0-59.1) and a disease control rate (DCR) of 93.1% (95% CI 86.4-97.2), as assessed by blinded independent central review (BICR), in patients with previously treated advanced or metastatic HER2-mutant (HER2m) NSCLC. One (1.0%) complete response (CR) and 49 (48.0%) partial responses (PR) were observed. The median duration of response (DoR) was 16.8 months (95% CI 6.4-not estimated [NE]). Median follow-up was 11.5 months at time of data cut-off of 23 December 2022.\n \nSusan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: \"HER2-mutant non-small cell lung cancer is an aggressive form of lung cancer that often affects younger patients and has a poor prognosis, with limited approved therapies. This milestone recognises the unmet need in the European Union and if approved, Enhertu will provide the first targeted treatment option for these patients.\"\n ...