Enhertu receives priority review for HER2-mutated non-small cell lung cancer
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The FDA granted priority review to trastuzumab deruxtecan for treatment of adults with unresectable or metastatic HER2-mutated non-small cell lung cancer, according to a press release from the agent’s manufacturer.
The designation applies to use of the HER2-directed antibody-drug conjugate by patients who received at least one prior systemic therapy.
Trastuzumab deruxtecan (Enhertu; AstraZeneca, Daiichi Sankyo) is approved in the United States for treatment of adults with unresectable or metastatic HER2-positive breast cancer who received two or more prior anti-HER2-based regimens in the metastatic setting. It also is approved for treatment of adults with locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who received a prior trastuzumab-based regimen.
The priority review for the lung cancer indication is based on results of the phase 2 DESTINY-Lung01 trial, presented in September during the virtual ESMO Congress 2021 and published in The New England Journal of Medicine.
Among 91 previously treated patients with HER mutations who received trastuzumab deruxtecan dosed at 6.4 mg/kg every 3 weeks, researchers reported a confirmed objective response rate of 54.9% (95% CI, 44.2-65.4) as assessed by independent central review. They observed one complete response and 49 partial responses.
Results also showed a confirmed disease control rate of 92.3%, with most patients experiencing tumor shrinkage. After median follow-up of 13.1 months, patients demonstrated a median duration of response of 9.3 months. Researchers reported median PFS of 8.2 months (95% CI, 6-11.9) and median OS of 17.8 months (95% CI, 13.8-22.1).
The safety profile appeared consistent with previous clinical trials of trastuzumab deruxtecan, with no new safety concerns.
“The DESTINY-Lung01 trial confirmed the HER2 mutation as an actionable biomarker in non-small cell lung cancer,” Susan Galbraith, executive vice president of oncology research and development for AstraZeneca, said in the 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.”
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