ENHERTU receives EU approval for advanced non-small cell lung cancer

The European Union (EU) has given its nod to ENHERTU (trastuzumab deruxtecan) for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) that have an activating HER2 (ERBB2) mutation, following platinum-based chemotherapy treatment with or without immunotherapy. This significant decision is backed by the positive outcomes of the DESTINY-Lung02 phase 2 trial, as presented at the IASLC 2023 World Conference on Lung Cancer.

Joint Endeavors by Daiichi Sankyo and AstraZeneca Yield Fruit

The collaboration between Daiichi Sankyo and AstraZeneca led to the development and commercialization of ENHERTU, a uniquely designed HER2 directed antibody drug conjugate (ADC). The European Commission’s endorsement is a major advancement following the Committee for Medicinal Products for Human Use (CHMP)’s positive opinion.

Strong Data from the DESTINY-Lung02 Trial

The DESTINY-Lung02 findings revealed that ENHERTU showed a confirmed objective response rate (ORR) of 49.0% in patients with previously treated advanced or metastatic HER2 mutant NSCLC. The median duration of response was noted at 16.8 months.

Professor Martin Reck, MD, commented, “ENHERTU is the first HER2 directed therapy to demonstrate robust and long-lasting results for these patients, signifying a leap in treatment methods for the disease.”

Daiichi Sankyo and AstraZeneca on ENHERTU’s Expanding Scope

Ken Keller of Daiichi Sankyo stated, “ENHERTU’s approval for lung cancer in the EU is a landmark, marking its validation for three distinct tumor types.” AstraZeneca’s Dave Fredrickson echoed the sentiment, highlighting the pivotal role of ENHERTU as a HER2 targeted option.

A Glimpse into the DESTINY-Lung02’s Safety Metrics

No new safety signals were detected for ENHERTU, remaining consistent with earlier trials.

Milestone Payment Post EU Approval

Following this EU approval, AstraZeneca owes Daiichi Sankyo a milestone payment of $75 million regarding HER2 mutant non-small cell lung cancer.

The Clinical Significance of ENHERTU

ENHERTU, designed with Daiichi Sankyo’s proprietary DXd ADC technology, stands as a leading ADC in the oncology portfolios of both Daiichi Sankyo and AstraZeneca. It’s presently approved in multiple countries for treating various types of cancer based on results from different DESTINY trials.