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.
See Also:
In cohort 2, Trodelvy monotherapy is assessed in platinum-ineligible patients following progression on anti-PD-1/PD-L1-based immunotherapy.
How well do you really know your competitors?
Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.
Thank you!
Your download email will arrive shortly
Not ready to buy yet? Download a free sample
We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form
By GlobalDataCohort 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.
