Competitive PerformanceThe efficacy still falls short of the 64-73% overall response rate seen with Padcev in the same setting, which has increasingly become the standard of care for first-line metastatic urothelial cancer.
Safety ConcernsThe safety profile has deteriorated versus the previous update and includes an increased incidence of peripheral neuropathy.
Trial DelaysThe enrollment for the Duravelo-2 trial is slower than expected, potentially delaying the timeline for dose selection and top-line results.