Enhertu Granted Priority Review for Previously Treated HER2-Mutant Metastatic Non-Small Cell Lung Cancer


Additionally, the safety profile in DESTINY-Lung01 was consistent with previous clinical trials with no new safety concerns identified.

The FDA has granted priority review to a supplemental Biologics License Application (sBLA) for trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 (ERBB2) mutation and who have received a prior systematic therapy.

The sBLA for trastuzumab deruxtecan, a HER2-directed antibody drug conjugate (ADC), is supported by findings from the phase 2 DESTINY-Lung01 (NCT03505710) and phase 1 DS8201-A-J101 (NCT02564900) trials. The drug consists of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload, an exatecan derivative, through a stable tetrapeptide-based cleavable linker.

Prognosis is poor for patients with metastatic NSCLC, as only approximately 8% will live beyond 5 years after diagnosis. Further, there are no HER2-directed therapies approved specifically for the treatment of HER2-mutant NSCLC, which occurs in approximately 2% to 4% of patients with non-squamous NSCLC.

“The DESTINY-Lung01 trial confirmed the HER2 mutation as an actionable biomarker in non-small cell lung cancer,” said Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, in a press release. “If approved, Enhertu has the potential to become a new standard treatment in this patient population, offering a much-needed option for patients with HER2-mutant metastatic non-small cell lung cancer who currently have no targeted treatment options.”

Data from the registrational DESTINY-Lung01 phase 2 trial confirmed an objective response rate of 54.9% in patients treated with trastuzumab deruxtecan.

Data also showed a confirmed disease control rate (DCR) of 92.3% with a reduction in tumor size observed in most patients. At a median follow-up of 13.1 months, the median duration of response (for trastuzumab deruxtecan was 9.3 months, median progression-free survival was 8.2 months, and median overall survival was 17.8 months.

Additionally, the safety profile in DESTINY-Lung01 was consistent with previous clinical trials with no new safety concerns identified.

Trastuzumab deruxtecan is being further evaluated in a clinical development program that is analyzing the efficacy and safety across multiple HER2-targetable cancers, including breast, gastric, lung, and colorectal cancers.

“The results of DESTINY-Lung01 showed that Enhertu is the first HER2-directed therapy to demonstrate a strong and robust tumor response in more than half of patients with previously treated HER2-mutant metastatic non-small cell lung cancer,” Ken Takeshita, MD, global head, R&D, Daiichi Sankyo, said in a press release. “Seeking approval in the US for a third tumour type in 3 years further demonstrates the significant potential of Enhertu in treating multiple HER2-targetable cancers.”


Enhertu granted Priority Review in the US for patients with previously treated HER2-mutant metastatic non-small cell lung cancer. AstraZeneca. April 19, 2022. Accessed April 19, 2022. https://www.astrazeneca.com/media-centre/press-releases/2022/enhertu-granted-priority-review-for-her2m-nsclc.html

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