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Daiichi Sankyo, AstraZeneca Begin Phase II Study of Enhertu in HER2-Mutated NSCLC

NEW YORK – Daiichi Sankyo and AstraZeneca said on Monday they have dosed the first patient in a Phase II study of trastuzumab deruxtecan (Enhertu) in HER2-mutated, metastatic non-small cell lung cancer.

The study, called DESTINY-Lung02, will enroll approximately 150 patients whose disease has progressed after at least one prior platinum-containing treatment, and patients will be randomized to receive either a 5.4 mg/kg dose of the drug or a 6.4 mg/kg dose.

The primary endpoint in the study is objective response rate and secondary endpoints include disease control rate, duration of response, progression-free survival, investigator-assessed ORR, overall survival, pharmacokinetics, time to response, quality of life, and safety.

Data from a previous Phase II study, DESTINY-Lung01, of trastuzumab deruxtecan in HER2-mutated NSCLC showed an objective response rate of 61.9 percent, a disease control rate of 90.5 percent, and median progression-free survival of 14 months. Median duration of response and overall survival were not reached as of the data cutoff.

"Our initial research of Enhertu in the DESTINY-Lung01 trial has shown impressive early results in patients with HER2-mutated, metastatic non-small cell lung cancer," Gilles Gallant, global head of oncology development at Daiichi Sankyo, said in a statement. "Building on these results, we are initiating the DESTINY-Lung02 trial to further explore the safety and efficacy of two different doses of Enhertu in this specific type of non-small cell lung cancer."

The US Food and Drug Administration granted breakthrough therapy designation to trastuzumab deruxtecan in this indication last May. Trastuzumab deruxtecan is already approved to treat HER2-positive breast cancer in the US, UK, Europe, and Japan. It is also approved for HER2-positive gastric or gastroesophageal junction cancer in the US and Japan.