FY2022 Q3 Financial and R&D Update
ENHERTU® Gastric Cancer Update
ENHERTU® was approved in the EU for patients with HER2+ unresectable
advanced/recurrent gastric cancer in Dec 2022
Approval was based on the results from Ph2 study for 2nd line treatment in unresectable
advanced/recurrent gastric cancer (DESTINY-Gastric02 in North America and Europe) and Ph2 study for
3rd line treatment (DESTINY-Gastric01 in Japan and Korea)
DESTINY-Gastric02 data presented at ESMO 2022
■ORR (Primary endpoint): 41.8% (95% CI: 30.8-53.4)
■DOR: 8.1 months (95% CI: 5.9-NE)
■ Safety profile was generally consistent with the established safety profile of ENHERTU®
■ Approval for the 2nd cancer type following breast cancer by EMA
Daiichi-Sankyo
CI: confidence interval, DoR: duration of response, EMA: European Medicines Agency, ESMO: European Society for Medical Oncology, NE: not estimable, ORR: objective response rate 21View entire presentation