Positive results from the primary analysis of the ongoing DESTINY-PanTumor02 Phase II trial showed that Enhertu (trastuzumab deruxtecan) continued to demonstrate clinically meaningful and durable responses, leading to a clinically meaningful survival benefit in previously treated patients across multiple HER2-expressing advanced solid tumours.
These results, which include the first progression-free survival (PFS) and overall survival (OS) findings reported from the trial, were presented today at the 2023 European Society for Medical Oncology (ESMO) Congress (abstract #LBA34) in Madrid, Spain and simultaneously published in the Journal of Clinical Oncology.
Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.
In the primary analysis, Enhertu demonstrated a median PFS of 6.9 months (95% confidence interval [CI] 5.6-8.0) and a median OS of 13.4 months (95% CI 11.9-15.5) in the overall trial population of previously treated patients with HER2-expressing advanced solid tumours, including either biliary tract, bladder, cervical, endometrial, ovarian, pancreatic cancers or other tumours, as assessed by investigator. Enhertu also continued to show a confirmed objective response rate (ORR) of 37.1% and a median duration of response (DoR) of 11.3 months (95% CI 9.6-17.8) in these patients.
Funda Meric-Bernstam, MD, Chair of Investigational Cancer Therapeutics at The University of Texas MD Anderson Cancer Center, US and principal investigator for the trial, said: "These primary analysis results confirm the efficacy shown at an interim analysis of the DESTINY-PanTumor02 trial, with responses leading to clinically meaningful survival outcomes across a broad range of HER2-expressing solid tumours. Based on these results, Enhertu has the potential to change the course of disease for certain patients with HER2-expressing advanced cancers who have limited treatment options and currently no approved HER2-directed therapies."
Cristian Massacesi, Chief Medical Officer and Oncology Chief Development Officer, AstraZeneca, said: "These updated data from DESTINY-PanTumor02 continue to illustrate the importance of HER2 as an actionable biomarker across a range of studied solid tumour types. Enhertu has the potential to offer improved outcomes for specific patients with previously treated HER2-expressing cancers, and we hope to bring this important medicine to patients as quickly as possible."
Mark Rutstein, MD, Global Head, Oncology Clinical Development, Daiichi Sankyo, said: "Improving survival outcomes for patients is one of the primary goals of cancer treatment and the clinically meaningful progression-free and overall survival results seen in DESTINY-PanTumor02 are encouraging. These results provide additional evidence for Enhertu to potentially become the first antibody drug conjugate approved in a tumour-agnostic setting in patients whose tumours express HER2."
Summary of results: DESTINY-PanTumor02 primary analysis
