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Thomas Powles, MD, MBBS, MRCP, discusses the utility of maintenance avelumab in the phase 3 JAVELIN Bladder 100 study in advanced urothelial carcinoma.
Thomas Powles, MD, MBBS, MRCP, director, Barts Cancer Institute, discusses the utility of maintenance avelumab (Bavencio) in the phase 3 JAVELIN Bladder 100 study in advanced urothelial carcinoma.
Patients who were treated with maintenance avelumab sequenced directly after frontline chemotherapy for metastatic urothelial cancer experienced a hazard ratio (HR) of survival of 0.69, says Powles. The median overall survival (OS) of the avelumab arm was 21 months versus 14 months in the best supportive care arm. The co-primary end points of the trial included the PD-L1—positive population and the OS in that group was not reached with a median follow-up of 19 months. The HR of that population investigators was found to be 0.56, which is very comparative, says Powles. Overall, the trial achieved both primary OS end points.
Investigators also looked at progression-free survival (PFS) and saw similar HRs in the 0.50-0.60 range. A plateau with PFS with avelumab was also reported and the reason as to why that is relevant is because disease control is being achieved in large subgroups of patients that investigators have been struggling with in the second-line setting, explains Powles.
The next big thing concerns plot analysis and subsets. Were there some groups that did well and others that did poorly? The answer is that avelumab maintenance seemed to work broadly across different subgroups. It does not seem to matter which chemotherapy was given or whether there was a response or stable disease with that chemotherapy; the approach seemed to work with visceral metastases as well as in the absence of these metastases. Overall, it works in broad subgroups of patients, concludes Powles.