Clinical Trial ResultsThe interim results from the Phase 3 study did not meet statistical significance, and there is uncertainty regarding the numerical benefit in the treatment arm as the ORR numbers were not disclosed.
Efficacy ConcernsThe updated ORR appears to be only marginally additive to pembro alone of less than 10%, raising doubts about the potential survival benefit.
Safety ConcernsThe safety profile showed Grade 3-4 treatment-related adverse events in 24% of patients, which is slightly higher than some comparable studies.