NEW YORK – AstraZeneca on Thursday said it is in discussions with health authorities about regulatory filings for Enhertu (trastuzumab deruxtecan) based on new results from the ongoing Phase II DESTINY-PanTumor02 trial in which patients with HER2-expressing advanced solid tumors treated with the drug showed clinically meaningful progression-free survival and overall survival.
In the open-label trial, investigators are evaluating the clinical activity and risk-benefit profile of Enhertu in previously treated patients with HER2-expressing urothelial cancer, biliary tract cancer, cervical cancer, endometrial cancer, ovarian cancer, pancreatic cancer, and rare tumors with a primary outcome measure of objective response rate, with secondary endpoints of progression-free survival and overall survival.
The data analysis also yielded results for objective response rate and duration of response that were consistent with an interim analysis previously presented at the 2023 American Society of Clinical Oncology annual meeting. At that time, AstraZeneca and its partner Daiichi Sankyo reported an overall response rate of 37.1 percent with a median duration of response of 11.8 months.
"The progression-free survival and overall survival results for Enhertu alongside the continued robust and durable tumor responses seen with further follow-up underscore the potential value of this important medicine for patients with HER2-expressing cancers who currently have no targeted treatment options," Cristian Massacesi, AstraZeneca's chief medical officer and oncology chief development officer, said in a statement. "With a high unmet need in these cancers, we are working with health authorities to bring Enhertu to patients with HER2-expressing cancers that could potentially benefit from this medicine as quickly as possible."