RE:RE:AstraZeneca's ADC disappoints - on severe adverse eventsMay 30, 2024 - " Gilead Sciences' Trodelvy has failed a second phase 3 trial. Gilead reported Thursday that Trodelvy failed to move the needle in a bladder cancer study.
The TROP2-directed antibody-drug conjugate couldn’t outperform single-agent chemotherapy at extending the lives of urothelial cancer patients who had tried prior treatment with a chemotherapy and a PD-1/L1 therapy.
What’s more, the study linked Trodelvy to a higher number of deaths due to adverse events compared with chemo. The deaths were mostly seen early in treatment and related to complications from neutropenia, including infection, the company said.
The repeated clinical woes come as Gilead prepares to face off against fellow TROP2 ADCs from Merck and AZ/Daiichi. Merck’s sacituzumab tirumotecan, which is in-licensed from China’s Kelun-Biotech, has yet to report phase 3 data from a global study.
As for AZ and Daiichi’s datopotamab deruxtecan, the drug is under FDA review in HR-positive, HER2-negative breast cancer and in nonsquamous NSCLC. "
In contrast Pfizer's enfortumab vedotin, sold under the brand name Padcev, is an antibody-drug conjugate currently used for the treatment of urothelial cancer in combination with the checkpoint inhibitor pembrolizumab ( Keytruda).
https://www.fiercepharma.com/pharma/gileads-trodelvy-suffers-double-whammy-failed-bladder-cancer-trial-flags-early-deaths