Gilead Sciences has reported updated positive data from three cohorts of the Phase II TROPHY-U-01 clinical trial of Trodelvy (sacituzumab govitecan-hziy) to treat patients with metastatic urothelial cancer (mUC), the most common type of bladder cancer.
Based on these results, it was observed that the first-in-class, Trop-2 directed antibody-drug conjugate produced rapid, as well as durable, responses for a range of hard-to-treat types of mUC including platinum-ineligible and progressing, post-platinum mUC.
The global, multi-centre, open-label, multi-cohort, single-arm Phase II trial underway is assessing Trodelvy as a monotherapy or as a combination treatment in mUC patients after progression on a platinum-based regimen and anti-PD-1/PD-L1-based immunotherapy.
Cohort 1 of the trial is evaluating Trodelvy after progression on platinum-based chemotherapy and checkpoint inhibitor (CPI) therapy.
The trial’s cohorts 2, 3, 4, and 5 are ongoing.
In cohort 2, Trodelvy monotherapy is assessed in platinum-ineligible patients following progression on anti-PD-1/PD-L1-based immunotherapy.
Cohort 3 is assessing it in rapidly progressing mUC patients who progressed after platinum-based therapy.
Cohorts 4 and 5 in the trial are evaluating Trodelvy combination therapy in treatment naive mUC patients, with subjects in cohort 4 receiving cisplatin and Cohort 5 receiving cisplatin and avelumab, in addition to Trodelvy.
Gilead Oncology senior vice-president, therapeutic area head Bill Grossman said: “The TROPHY-U-01 data show consistent benefit of Trodelvy across multiple types of metastatic urothelial cancer, including the most difficult-to-treat and, often times, frail patients where treatment options are still scarce.
“Trodelvy has the potential to become a cornerstone treatment in metastatic urothelial cancer, and we are excited about the expected results from the ongoing Phase III TROPiCS-04 study that may serve to convert our US accelerated approval to full approval for Trodelvy to treat patients with locally advanced or metastatic urothelial cancer following a platinum-containing chemotherapy and PD-1/PD-L1 inhibitor.”
Last month, Gilead Sciences partnered with Strata Oncology to provide Trodelvy for eligible cancer patients in the Strata PATH trial.
