Efficacy and safety
pulmonary sepsis, craniocerebral injury, urothelial bladder cancer
ADVERSE EVENT, URINARY TRACT INFECTION
Five patients in the UBC cohort and one in the pancreatic cancer/cholangiocarcinoma cohort exhibited a PR, corresponding to an overall response rate (ORR; 90% CI) of 38.5% (16.57–64.52%) and 14.3% (0.73–52.07%), respectively. No patient in either cohort had a CR (Table In total, 84.6% (11/13) of patients in the UBC cohort experienced ≥1 AE, all considered treatment‐related (Table Safety summary.Abbreviations: AE, adverse event; qw, weekly; T‐DM1, trastuzumab emtansine; UBC, urothelial bladder cancer.Only preferred terms reported in ≥4 patients in either cohort are presented.No grade ≥3 AE occurred in more than one patient.The only serious AE to occur in more than one patient was urinary tract infection, which was reported in two patients. Both patients were administered T‐DM1 2.4 mg/kg qw.No serious AE occurred in more than one patient in the pancreatic cancer/cholangiocarcinoma cohort.Three of the six serious AEs reported in the UBC cohort led to discontinuation of T‐DM1. These three AEs were also fatal, and each (pulmonary sepsis, craniocerebral injury, and urinary tract infection) occurred in one patient. None was considered by the study investigator to be related to T‐DM1.Each of the seven patients in the pancreatic cancer/cholangiocarcinoma cohort experienced ≥1 AE; all but one was considered related to T‐DM1 (Table 