AstraZeneca Enhertu recommended for nod in EU by CHMP for HER2-mutant advanced non-small cell lung cancer
Cambridge: AstraZeneca and Daiichi Sankyo’s (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.
Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
The 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.
In 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.
Susan 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.”
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said, “Enhertu is the first therapy to demonstrate a strong and durable tumour response in patients with previously treated HER2-mutant advanced non-small cell lung cancer, validating HER2 as an actionable target in lung cancer and supporting the potential to provide a much-needed option for these patients. This CHMP opinion is a positive step forward in advancing this HER2-directed antibody drug conjugate for these patients and we look forward to the European Commission decision.”
The safety profile of Enhertu in the DESTINY-Lung02 trial was consistent with previous clinical trials with no new safety signals identified.
