Transcript

I'm Dr Petros Grivas. I'm a Medical Oncologist at Seattle Cancer Care Alliance. I'm an Associate Professor at University of Washington and Fred Hutchinson Cancer Research Center.

It's a very exciting time at the ASCO 2020, even with a virtual format. There is very important data being presented, and we are very happy to present the results of the practice-changing phase 3 under my clinical trial called JAVELIN Bladder 100 trial, which is, in my opinion, going to alter the way we treat patients with metastatic urothelial cancer.

The JAVELIN Bladder 100 trial is designed to ask the following question, "What should we do when we complete front-line chemotherapy in patients with metastatic urothelial cancer?"

Usually, what has happened so far, patients who complete this front-line chemotherapy, they get observed over time until they develop progression. Usually, the median progression-free survival is about seven to eight months in this front-line setting in advanced urothelial cancer.

With that in mind, we wanted to see whether the switch maintenance approach with anti-PD-L1 therapy with avelumab plus best supportive care, compared to best supportive care alone, can prolong overall survival.

We randomized patients to either avelumab plus best-supported care versus best supportive care alone in this population that just completed front-line induction chemotherapy with platinum-based regimens and had no progression. They had response or stable disease.

The study was conducted in multiple areas of the world. As I mentioned, 700 patients, overall, were enrolled. The results of the study are presented at the ASCO 2020 plenary section by Dr Powles.

The avelumab plus best supportive care led to significant prolongation of overall survival. The numbers were pretty remarkable. The difference was in the order of about seven months in terms of median overall survival difference and captured by the hazard ratio of 0.69, favoring the avelumab plus best supportive care versus best supportive care alone.

In terms of the additional endpoints, the study also showed prolongation in progress-free survival that was significant, and also a significant difference, you can argue, the response rates, although the response rate is not the best endpoint in a switch maintenance study.

In terms of safety and toxicity, there was no new concern. What we show was consistent with what we know with immune checkpoint inhibitors in advanced urothelial cancer with a classical, relatively low proportion of significant immunotherapy-related adverse events.

The specific data has been presented in the abstract and, hopefully, the publication soon. We reported treatment-emergent adverse events, regardless of cause, as well as treatment-related adverse events. Again, no new safety signals. Overall, this study I think is going to impact the way we practice.

Right now, after a patient completes front-line induction chemotherapy with platinum-based regimens and they have no progression, meaning they have response or stable disease, they go ahead with the switch maintenance avelumab in this front-line setting, in the attempt to delay recurrence, delay progression, and prolong survival, as was shown in this particular study.

This applies to all comers. There is no biomarker base in selection. It applies to all patients. Based on the findings the primary end point was all-comers in this study.