Background on the STRONG Study of Durvalumab in Urinary Tract Carcinoma

Guru P. Sonpavde, MD, a medical oncologist, and the GU Oncology director, Christopher K. Glanz Chair for Bladder Cancer Research, AdventHealth Cancer Institute, provides rationale for the phase 3b STRONG study (NCT03084471) and discusses the early data.

Sonpavde says that durvalumab (Imfinzi), as used in the STRONG study, is an FDA-approved treatment for patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy, or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy. The FDA-recommended dose of durvalumab was 10 mg/kg given intravenously over 60 minutes every 2 weeks. In STRONG, investigators increased the dosage of durvalumab to 1,500 mg to determine the safety and efficacy of the higher dose.

Transcript:

0:07 | So, the STRONG study was a phase 3B study that examined fixed dose durvalumab. So, we administered durvalumab at 1m500 milligrams, intravenously every 4 weeks in patients with metastatic urothelial carcinoma who progressed on or after platinum-based chemotherapy. So, that is a little bit different than the experience so far. Durvalumab was approved for metastatic urothelial [cancer], which was basically using the 10 milligram per kilogram dose once every 2 weeks.

0:46 | The other difference in the STRONG study was that the study allowed both urothelial and non-urothelial carcinoma. Also, in terms of prior therapy, in addition to platinum- based chemotherapy, it allowed other types of chemotherapy. This is why the STRONG study was done, to essentially to look at the safety and toxicity profile of this fixed dose durvalumab, but also look at these other groups of patients that were not studied in the initial studies.

1:20 | What was previously presented was a phase 2 trial. It was a large non-randomized phase 2 trial called the 1108 trial, in which there was at a dose of 10 milligrams per kilo, every 2 weeks intravenously, was looked at in patients with metastatic urothelial or predominantly urothelial carcinoma. And based on that study, which showed a response rate in the 15% range, with safety, also demonstrated, led to the approval of the durvalumab in this population, this has been about three years ago now. So, that is the background before [the STRONG] study was launched.