Patients
PD, UBC, urothelial bladder cancer
RECRUITMENT, DISEASE, METASTATIC DISEASE, ADVERSE EVENT, PANCREATIC CANCER, ONCOLOGY, PRIMARY TUMOR, METASTASES, DISEASE CHARACTERISTIC, CHOLANGIOCARCINOMA
KAMELEON was conducted between October 25, 2016, and April 10, 2018. Recruitment was halted on September 22, 2017, due to the difficulty in recruiting enough patients for the primary efficacy analysis within a reasonable timeframe. In the UBC cohort, screening was performed on the primary tumor in ~80% of patients and on metastases in ~20% of patients. In the pancreatic cancer/cholangiocarcinoma cohort, these values were 63% and 37%, respectively. Across all cohorts, ~60% of tissues were derived from resection samples and 40% from biopsies. Among all 314 screened patients, 284 were successfully tested for HER2 overexpression by IHC (69 patients with UBC, 133 with pancreatic cancer, and 82 with cholangiocarcinoma). Of these, 25% (17/69), 4% (5/133), and 7% (6/82) were HER2‐positive, respectively, and 20 patients (UBC, Patient disposition in the KAMELEON study. AE, adverse event; PD, progressive disease; qw, weekly; q3w, every 3 weeks; T‐DM1, trastuzumab emtansine; UBC, urothelial bladder cancer.All patients with UBC had metastatic disease (Table Baseline demographics and disease characteristics.Abbreviations: ECOG, Eastern Cooperative Oncology Group; PS, performance status.Exposure and efficacy outcomes.Abbreviations: BOR, best overall response; CI, confidence interval; CR, complete response; DOR, duration of response; NE, not evaluable; ORR, overall response rate; OS, overall survival; PD, progressive disease; PFS, progression‐free survival; PR, partial response; SD, stable disease.Kaplan–Meier estimate. The corresponding 95% CI was computed using the Brookmeyer and Crowley method.The 90% CI was computed using the Clopper–Pearson approach.The response duration in the one patient in the pancreatic cancer/cholangiocarcinoma cohort with a PR was 8.6 months.