Discussion
deaths, TRAEs, tumor
TUMOR
There is a high unmet need for treating MSS metastatic CRC. In phase I study, MSI testing was performed on 50% of enrolled patients, all of whom had MSS CRC. A single PR (duration of 8.3 months) was observed. The ORR was 3.1% per IRC assessment, with a DCR of 6.3%. Current studies of anti–PD-1 agents suggest that their clinical effect is generally unencouraging in patients with pMMR or MSS CRC.Grade 3 TRAEs occurred in 4 patients (12.5%), and no grade ≥4 TRAEs or treatment-related deaths occurred. Bintrafusp alfa had a manageable safety profile in patients with advanced CRC, consistent with that observed in patients with solid tumorsStudy limitations include the lack of a comparator arm and the small number of patients, which made it difficult to interpret the magnitude of benefit with bintrafusp alfa. The findings of this study suggest that bintrafusp alfa may play a role in tumor control in select patients; however, further investigation is needed.