EfficacyThe updated ORR appears to be only marginally additive to pembro alone of less than 10%.
Safety ConcernsThe safety profile showed Grade 3-4 treatment-related adverse events in 24% of patients, which is slightly higher than some comparable studies.
Study 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.