AstraZeneca (NASDAQ:AZN) and Daiichi Sankyo (OTCPK:DSKYF) (OTCPK:DSNKY) said their drug Enhertu met the target for objective response rate (ORR) and showed durable response in multiple HER2-expressing advanced solid tumors in heavily pretreated patients in an ongoing phase 2 trial.
The phase 2 study, dubbed DESTINY-PanTumor02, is evaluating Enhertu in patients with locally advanced, unresectable, or metastatic previously treated, HER2-expressing solid tumors, including biliary tract cancer, bladder cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer and rare tumors. These patients are not candidates for curative treatment, according to the companies.
The main goal of the study is confirmed ORR, while duration of response (DoR) is a key secondary goal.
“Enhertu has already demonstrated its potential to improve outcomes for patients with HER2-targetable breast, gastric and lung cancers, and these positive initial results in other tumour settings with significant unmet need are very encouraging,” said Cristian Massacesi, chief medical officer and Oncology chief development officer, AstraZeneca.
The British pharma giant said that the safety profile of Enhertu in the phase 2 trial was consistent with that seen in other studies of the drug and no new safety signals were seen.
The companies noted that the data will be shared with global regulatory authorities and will also be presented at an upcoming medical meeting.
Enhertu (trastuzumab deruxtecan) is an engineered HER2-directed antibody drug conjugate (ADC) jointly developed and commercialized by AstraZeneca and Japanese drugmaker Daiichi Sankyo.