DESTINY-Pan Tumor 02 Subgroup Analysis

In a subgroup population analysis from the DESTINY-Pan Tumor 02 study, the efficacy of T-DXd in patients with urothelial cancer expressing the HER2 receptor was evaluated. The study enrolled patients with HER2 receptor expression levels of 2+ and 3+ and assessed the activity of T-DXd in a pre-treated patient population with urothelial cancer.

The results demonstrated that T-DXd is an active antibody-drug conjugate that provides clinically meaningful benefits to urothelial cancer patients with HER2 expression levels of 2+ and 3+. Specifically, we achieved an objective response rate of 34% in HER2 2+ patients and up to 56% in HER2 3+ patients. Additionally, the median PFS was seven months, and the median OS exceeded ten months.

These findings indicate that T-DXd, a drug approved in Europe for HER2-positive breast cancer patients, is also effective in urothelial cancer patients with advanced disease. This suggests that T-DXd may represent a novel treatment option for this particular population. While the drug has been approved in the US based on the results of the DESTINY-Pan Tumor 02 study and is available to patients with solid malignancies expressing the HER2 receptor, it is not yet approved in Europe for this indication. There is hope that studies like this will pave the way for final registrational studies and subsequent approval in Europe.