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Trastuzumab Deruxtecan for HER2-Positive Esophagogastric Cancer in U.S. and European Patients
The antibody–drug conjugate trastuzumab deruxtecan (T-DXd) has substantial activity across a spectrum of HER2-positive cancers. In HER2-positive gastric cancer, second or later line use of T-DXd is approved in the U.S. based on superiority for this agent over conventional chemotherapy, as reported in the DESTINY-Gastric01 trial conducted in Japan and South Korea (NEJM JW Oncol Hematol Jun 11 2020 and N Engl J Med 2020 382:2419).
Investigators now report results from DESTINY-Gastric02, an industry-sponsored, multicenter, phase 2 trial evaluating T-DXd (6.4 mg/kg intravenously every 3 weeks) in patients recruited in the U.S. and Europe. Patients were required to have disease progression on trastuzumab-based first-line chemotherapy. Of 89 patients screened, 79 (89%) were eligible and met the criterion of retention of HER2-positive status on central review of repeat pretreatment biopsy. One third of patients had gastric primaries and two thirds had gastroesophageal junction primaries; 86% of cancers were HER2-positive IHC 3+ and 13% were IHC 2+/FISH+. No patient had prior gastrectomy and 94% had two or more metastatic disease sites.
The primary endpoint of centrally confirmed response was 38% and median duration of response was 8.1 months. Median progression-free survival was 5.5 months and overall survival was 12.1 months. The most common grade 3 or higher treatment-related adverse events were hematologic. Interstitial lung disease, a known side effect of T-DXd, occurred in 8 patients (10%) with a median time to onset of 80.5 days and included two grade 1 cases, four grade 2 cases, and two grade 5 fatal events.
DESTINY-Gastric02 is a confirmatory phase 2 trial indicating that patients with esophagogastric cancer in the U.S. and Europe have similar response rate, response duration, progression-free survival, and overall survival as those in Japan and South Korea – the DESTINY-Gastric01 trial population. T-DXd is now approved for second- or later-line use in HER2-positive esophagogastric adenocarcinoma.
Van Cutsem E et al.
Title: Trastuzumab deruxtecan in patients in the USA and Europe with HER2-positive advanced gastric or gastroesophageal junction cancer with disease progression on or after a trastuzumab-containing regimen (DESTINY-Gastric02): Primary and updated analyses from a single-arm, phase 2 study.
Source: Lancet Oncol 2023 Jul ; [e-pub]. (Abstract/FREE Full Text)