Clinical Trial UncertaintyThe 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.
Safety ConcernsThe safety profile showed Grade 3-4 treatment-related adverse events in 24% of patients, which is slightly higher than some comparable studies.
Treatment DiscontinuationThe treatment-related discontinuations were higher at 16% compared to a lower rate in other studies.