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EMA's CHMP Recommends AstraZeneca, Daiichi Sankyo's Enhertu in HER2-Mutated NSCLC

NEW YORK – AstraZeneca and Daiichi Sankyo on Friday said that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended Enhertu (trastuzumab deruxtecan) for patients with advanced non-small cell lung cancer whose tumors harbor HER2 activating mutations and who need systemic therapy after platinum-based chemotherapy.

The committee's recommendation is based on results from the Phase II DESTINY-Lung02 trial in which 152 patients with advanced HER2-mutant NSCLC received Enhertu. The objective response rate was 49 percent, and the disease control rate was 93.1 percent. One patient had a complete response on Enhertu, and 49 patients had partial responses. The median duration of response was 16.8 months at a median follow-up of 11.5 months.

"Enhertu is the first therapy to demonstrate a strong and durable tumor response in patients with previously treated HER2-mutant advanced non-small cell lung cancer, validating HER2 as an actionable target in lung cancer," Ken Takeshita, global head of R&D at Daiichi Sankyo, said in a statement.

Between 2 percent and 4 percent of NSCLC patients harbor HER2 mutations. If the European Commission takes up CHMP's recommendation, Enhertu will be the first HER2-targeted treatment to be approved in the European Union for this subset of patients.

Enhertu is an established therapy for HER2-positive and HER2-low metastatic breast cancer, and HER2-positive advanced gastric or gastroesophageal junction adenocarcinoma. The HER2-directed antibody-drug conjugate is already approved in Israel, Japan, and the US for patients with HER2-mutant metastatic NSCLC.

AstraZeneca and Daiichi Sankyo further believe the drug has utility as a tumor-agnostic therapy across solid tumor types and are building evidence for that indication in the Phase II DESTINY-PanTumor02 trial. As of an interim data readout in June, the overall response rate was 37.1 percent in a group of patients with HER2-positive tumors who had progressed on standard treatments.