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Trastuzumab Deruxtecan Wins EU Approval for HER2-Mutated Advanced NSCLC (DESTINY-Lung02 trial)

*October 2023*

The European Commission (EC) has approved fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of patients with advanced non–small cell lung cancer (NSCLC) whose tumors harbor an activating HER2 mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.1

The regulatory decision was supported by data from the phase 2 DESTINY-Lung02 trial (NCT04644237), which showed that patients with previously treated, HER2-mutated, advanced or metastatic NSCLC treated with 5.4 mg/kg of the antibody-drug conjugate (n = 102) experienced a confirmed overall response rate (ORR) of 49.0% (95% CI, 39.0%-59.1%) per blinded independent central review (BICR) assessment.2

Among responders, 1.0% achieved a complete response (CR) and 48.0% experienced a partial response (PR); 44.1% of patients had stable disease (SD), 3.9% had progressive disease (PD), and 2.9% were not evaluable for response. The disease control rate (DCR) was 93.1% (95% CI, 86.4%-97.2%). The median duration of response (DOR) was 16.8 months (95% CI, 6.4-not evaluable), and the median time to initial response (TTIR) was 1.8 months (range, 1.2-7.0).

HER2-mutant NSCLC is more commonly diagnosed in patients who are younger and female, and there are limited treatment options, which often results in a poor prognosis,” Martin Reck, MD, head of the Department of Thoracic Oncology at the Lung Clinic Grosshansdorf in Germany, stated in a news release.1 “[Trastuzumab deruxtecan] is the first HER2-directed therapy to demonstrate strong and durable results for these patients, and this approval in the European Union marks an important step forward in how the disease can be treated.”

In August 2022, the FDA granted accelerated approval to trastuzumab deruxtecan for adult patients with unresectable or metastatic NSCLC whose tumors have activating HER2 mutations, as detected by an FDA-approved test, and who have received previous systemic therapy.That decision was also based on findings from DESTINY-Lung02. Read more.