Enhertu approved by the FDA as the first HER2-directed therapy for patients with previously treated HER2-mutant metastatic non-small cell lung cancer
AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations, as detected by a FDA-approved test, and who have received a prior systemic therapy
This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
The accelerated approval by the FDA was based on the results from the DESTINY-Lung02 Phase II trial. An interim efficacy analysis in a pre-specified patient cohort showed Enhertu (5.4mg/kg) demonstrated a confirmed ORR of 57.7% (n=52; 95% confidence interval [CI] 43.2-71.3), as assessed by blinded independent central review (BICR), in patients with previously treated unresectable or metastatic non-squamous HER2-mutant (HER2m) NSCLC. Complete responses (CR) were seen in 1.9% of patients and partial responses (PR) in 55.8% of patients with a median DoR of 8.7 months (95% CI 7.1-NE). Results from the DESTINY-Lung02 trial will be presented at an upcoming medical meeting.
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