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Fam-Trastuzumab Deruxtecan-nxki Granted Priority Review in HER2-Mutant NSCLC

By: Lauren Velentzas
Posted: Thursday, April 21, 2022

The U.S. Food and Drug Administration (FDA) recently accepted the supplemental biologics license application of fam-trastuzumab deruxtecan-nxki (Enhertu) for the treatment of adults with previously treated, unresectable, or metastatic HER2-mutated non–small cell lung cancer (NSCLC), according to AstraZeneca and Daiichi Sankyo. The application also received Priority Review status. This anti-HER2 monoclonal antibody combined with a topoisomerase I inhibitor has been previously approved for treatment of adults with unresectable or metastatic HER2-positive breast cancer and locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma.

The supplemental biologics license application in NSCLC is based on results from the phase II DESTINY-Lung01 trial. These findings showed that of 91 previously treated adults with HER2 mutations who received trastuzumab deruxtecan at 6.4 mg/kg every 3 weeks, there was a confirmed objective response rate of 54.9% (95% confidence interval [CI] = 44.2%–65.4%), as well as 1 complete response and 49 partial responses. The results also showed a confirmed disease control rate of 92.3%. After a median follow-up of 13.1 months, patients demonstrated a median duration of response of 9.3 months, a median progression-free survival of 8.2 months (95% CI = 6–11.9 months), and a median overall survival of 17.8 months (95% CI = 13.8–22.1 months).

The safety profile of the most common adverse events with trastuzumab deruxtecan in DESTINY-Lung01 was consistent with previous clinical trials. Neutropenia (18.7%), anemia (9.9%), nausea (8.8%), fatigue (6.6%), leukopenia (4.4%), diarrhea (3.3%), and vomiting (3.3%) were the most common grade 3 or higher drug-related treatment-emergent adverse events.


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