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European Union

ENHERTU Receives EU Approval for Advanced Non-Small Cell Lung Cancer Treatment

Strategic Insights

— 1 min read

ENHERTU (trastuzumab deruxtecan) has been granted approval in the European Union as a monotherapy for treating adult patients with advanced non-small cell lung cancer (NSCLC) who have an activating HER2 (ERBB2) mutation and have received platinum-based chemotherapy with or without immunotherapy. This approval comes after the European Commission (EC) accepted the recommendation from the Committee for Medicinal Products for Human Use (CHMP), which was based on results from the DESTINY-Lung02 phase 2 trial. The trial demonstrated a confirmed objective response rate of 49.0% in patients with previously treated advanced or metastatic HER2 mutant NSCLC, with a complete response observed in 1.0% of patients and partial responses in 48.0%.

Key Takeaways:

  • ENHERTU is a specifically engineered HER2-directed antibody-drug conjugate (ADC) being jointly developed and commercialized by Daiichi Sankyo and AstraZeneca.
  • The approval is based on results from the DESTINY-Lung02 phase 2 trial, which presented a confirmed objective response rate of 49.0% in patients with HER2 mutant NSCLC.
  • In DESTINY-Lung02, a complete response was observed in 1.0% of patients, while partial responses were observed in 48.0%.
  • The DESTINY-Lung02 trial demonstrated a median duration of response of 16.8 months in patients with HER2 mutant NSCLC.
  • The safety profile of ENHERTU in DESTINY-Lung02 was consistent with other trials of ENHERTU, with no new safety signals observed.
  • Grade 3 or grade 4 treatment-related adverse events from a pooled safety analysis of ENHERTU 5.4 mg/kg across multiple tumor types include neutropenia (17.0%), anaemia (9.5%), fatigue (8.4%), and others.
  • A milestone payment of $75 million is due from AstraZeneca to Daiichi Sankyo following approval in HER2 mutant non-small cell lung cancer.
  • Sales of ENHERTU in most EU territories are recognized by Daiichi Sankyo.

Statistics:

  • Objective response rate (ORR): 49.0% (95% confidence interval: 39.0-59.1)
  • Complete responses: 1.0%
  • Partial responses: 48.0%
  • Median duration of response (DOR): 16.8 months (95% CI: 6.4-not estimable (NE))
  • Grade 3 or grade 4 treatment-related adverse events: neutropenia (17.0%), anaemia (9.5%), fatigue (8.4%), and others.

Sources:

  • Daiichi Sankyo Co Ltd, website: http://www.daiichisankyo.com/
  • Journal of Clinical Oncology, DESTINY-Lung02 phase 2 trial results
  • International Association for the Study of Lung Cancer (IASLC), 2023 World Conference on Lung Cancer hosted by the IASLC

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