Results from the primary analysis of the DESTINY-Lung02 Phase II trial showed Enhertu (trastuzumab deruxtecan) continued to demonstrate strong and durable tumour responses in previously treated patients with HER2-mutant (HER2m) unresectable and/or metastatic non-squamous non-small cell lung cancer (NSCLC).
These results, along with the first report on progression-free survival (PFS) and overall survival (OS), were presented today at the International Association for the Study of Lung Cancer (IASLC) 2023 World Conference on Lung Cancer (WCLC) (abstract #MA13.10) and simultaneously published in the Journal of Clinical Oncology.
Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
At the primary analysis, a confirmed objective response rate (ORR) of 49.0% and 56.0% was seen in the 5.4mg/kg arm and 6.4mg/kg arm respectively, as assessed by blinded independent central review (BICR). The safety profile for both doses was consistent with the overall safety profile of Enhertu, with the 5.4mg/kg dose demonstrating a favourable safety profile in this patient population.
Secondary endpoint data were also encouraging, with Enhertu demonstrating a median PFS of 9.9 months and 15.4 months in the 5.4mg/kg and 6.4mg/kg arms respectively, as assessed by BICR. A median OS of 19.5 months was achieved in the 5.4mg/kg arm and not reached in the 6.4mg/kg arm at time of analysis.
Pasi A. Jänne, MD, PhD, Director, Lowe Center for Thoracic Oncology and Belfer Center for Applied Cancer Science, Dana-Farber Cancer Institute, US, said: “The primary results from DESTINY-Lung02 demonstrate that Enhertu continues to show strong and durable tumour responses for patients treated at either dose. The favourable safety profile seen at the 5.4mg/kg dose continues to support the use of Enhertu in the treatment of patients with HER2-mutant non-small cell lung cancer, a particularly aggressive form of the disease where patients face a poor prognosis and have historically had few options.”
Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: “These results from DESTINY-Lung02 highlight that HER2 is an actionable target in lung cancer and reinforce the importance of testing for predictive biomarkers, including HER2 alterations, at the time of diagnosis to accurately identify patients who may be able to benefit from a targeted treatment. The data also reaffirm our belief in Enhertu as a potential new targeted treatment option for patients who have historically had limited options.”
Ken Takeshita, Global Head, R&D, Daiichi Sankyo, said: “The disease control achieved by more than 90% of patients with previously treated HER2-mutant non-small cell lung cancer in the primary analysis of DESTINY-Lung02 reinforces the efficacy we have already seen with Enhertu in this hard-to-treat disease. These results, along with encouraging progression-free survival and overall survival findings reported for the first time, demonstrate the potential role of Enhertu as an important treatment option for this patient population.”
Summary of results: DESTINY-Lung02 Primary analysis
