Bladder cancer next for Datroway

Datroway could expand its reach beyond lung and breast cancers, with the pivotal Tropion-Urothelial03 study in second-line bladder cancer launching next month, according to clinicaltrials.gov. This will evaluate the AstraZeneca/Daiichi Sankyo anti-TROP2 ADC in combination with chemotherapy for patients progressed on first-line Padcev and Keytruda. At this year’s ASCO-GU Daiichi presented data from 40 urothelial bladder cancer patients in the Tropion-Pantumor01 trial, 33 of whom had previously received Padcev. Datroway showed a confirmed ORR of 25% and median PFS of 6.9 months, a result that presumably backs entry into phase 3. The Datroway move is notable given that Gilead's rival Trodelvy last year failed the phase 3 Tropics-04 trial in post-Keytruda/chemo urothelial cancer, leading to the withdrawal of Trodelvy’s accelerated approval in the third-line setting. Meanwhile, the other key TROP2-targeting ADC, Merck & Co/Kelun's sacituzumab tirumotecan, also had data at ASCO-GU, with confirmed ORR of 46% and median PFS of 5.8 months among 11 second-line post-chemo patients. With Trodelvy’s failure and sacituzumab tirumotecan still in early development, Datroway now stands out as the only anti-TROP2 ADC in a pivotal trial in bladder cancer. Data from a Datroway and rilvegostomig combination are to be presented in October at ESMO. 

Second-line urothelial bladder cancer cross-trial comparison

Source: OncologyPipeline.