Sept. 22 Quick Takes: Daiichi-AZ’s TROP2 ADC meets PFS endpoint in Phase III

Datopotamab deruxtecan from Daiichi Sankyo Co. Ltd. (Tokyo:4568) and AstraZeneca plc (LSE:AZN; NYSE:AZN) met the primary progression-free survival (PFS) endpoint in HR-positive, HER2-low or -negative breast cancer in an interim analysis of the Phase III TROPION-Breast01 study, though the TROP2-targeting antibody-drug conjugate (ADC) has yet to prove an overall survival (OS) benefit. The partners’ HER2-targeting ADC Enhertu fam-trastuzumab deruxtecan was approved last year for much of the same patient population, and if approved, the TROP2 ADC would add another treatment option. It would also compete in class with Trodelvy sacituzumab from Gilead Sciences Inc. (NASDAQ:GILD) in the indication. Trodelvy, which was approved last year, also failed to show a significant OS benefit at an interim analysis.

Padcev enfortumab vedotin plus Keytruda pembrolizumab met the dual primary PFS and OS endpoints in the Phase III EV-302 (Keynote-A39) trial in first-line advanced or metastatic urothelial cancer. Success in the indication could lead to a major label expansion for the ADC targeting Nectin-4 from Seagen Inc. (NASDAQ:SGEN) and Astellas Pharma Inc. (Tokyo:4503), and could possibly lead to a shift in standard of care in first-line urothelial cancer from chemo. In April, the combination gained accelerated approval to treat patients not eligible for cisplatin-containing chemotherapy...