The STRONG trial was a Phase IIIb non-randomized trial that looked at durvalumab given in a fixed-dose formulation of 1500 milligrams IV every four weeks. Now remember that durvalumab is already FDA approved in patients with metastatic urothelial carcinoma with progressive disease, post platinum-based chemotherapy.
So STRONG looked at similar patients, post-platinum metastatic urothelial carcinoma with progressive disease...
The STRONG trial was a Phase IIIb non-randomized trial that looked at durvalumab given in a fixed-dose formulation of 1500 milligrams IV every four weeks. Now remember that durvalumab is already FDA approved in patients with metastatic urothelial carcinoma with progressive disease, post platinum-based chemotherapy.
So STRONG looked at similar patients, post-platinum metastatic urothelial carcinoma with progressive disease. And these patients received durvalumab under fixed dose of 1500 milligrams. There were a couple of other interesting distinctions between the STRONG trial and the dataset we have so far. One was that the STRONG trial allowed even non-urothelial histology. So, patients with pure non-urothelial who had no urothelial component were allowed. The other distinction is that this trial allowed patients who had prior chemotherapy, which may not even have been a platinum-based chemotherapy. So, these were the distinctions.
The bottom line is that durvalumab in this fixed-dose formulation every four weeks, 1500 milligrams, was safe and active. The activity and safety profile look similar to what has been known with the previously approved dose and formulation of durvalumab, which was 10 milligram per kilo every two weeks. So, we believe that based on this durvalumab is a reasonable option for these patients with progressive disease post platinum-based metastatic urothelial carcinoma. Again, durvalumab was given in this trial in a fixed-dose formulation. And indeed, the US FDA has now approved this dosing of durvalumab in this population, which is also of course more convenient. So, this is an interesting compliment to the body of data we have.