The FDA granted priority review to a supplemental biologics license application for trastuzumab deruxtecan in patients with HER2-positive gastric or gastroesophageal junction adenocarcinoma.
The FDA has accepted and granted a priority review designation to a supplemental biologics license application for the antibody-drug conjugate (ADC) trastuzumab deruxtecan (Enhertu) for use in patients with HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma.1 The application was based on data from the phase 2 DESTINY-Gastric01 trial, which showed that the ADC elicited a higher objective response rate (ORR) compared with chemotherapy in patients with advanced, HER2-positive gastric or GEJ adenocarcinoma who had progressed following trastuzumab (Herceptin)-containing treatment.2
Specifically, the ORR was 51.3% versus 14.3% with trastuzumab deruxtecan and chemotherapy, respectively. The ADC also led to a longer median overall survival (OS) compared with chemotherapy, at 12.5 months versus 8.4 months, respectively. Additionally, the median PFS and median duration of confirmed response (DOR) proved to be longer with trastuzumab deruxtecan.
“The results of the DESTINY-Gastric01 trial are unprecedented as they represent the first time a HER2-directed medicine has demonstrated an improvement in survival following chemotherapy and HER2 treatment in the metastatic setting,” Antoine Yver, executive vice president and global head, Oncology Research and Development at Daiichi Sankyo, stated in the press release. “Building on the recent breakthrough therapy designation, the filing of the application and priority review by the FDA for this potential new indication for [trastuzumab deruxtecan] reflects the importance of the data and the significant unmet need for patients with previously treated HER2-positive metastatic gastric cancer,” added Yver.