Patient Characteristics and Disposition
head and neck squamous cell carcinoma, SCLC, NSCLC, PD
COLORECTAL CANCER, SCLC, PROGRESSIVE DISEASE, UROTHELIAL CARCINOMA, SMALL CELL LUNG CANCER, NSCLC, ONCOLOGY, RENAL CELL CARCINOMA, RCC
At the data cut-off date (March 10, 2020), a total of 159 patients had been enrolled at 11 study sites and were included in both the safety population and FAS. Forty-nine patients were included in all of Part 1/Group A [itacitinib plus pembrolizumab; Patient demographics and baseline characteristics are summarized in Summary of demographic and baseline characteristicsAbbreviations: CRC, colorectal cancer; ECOG PS, Eastern Cooperative Oncology Group Performance Status; HNSCC, head and neck squamous cell carcinoma; NSCLC, non–small cell lung cancer; PD-L1, programmed death-ligand 1; Q3W, every 3 weeks; QD, once daily; RCC, renal cell carcinoma; SCLC, small cell lung cancer; UC, urothelial carcinoma.
All 49 patients in Part 1a/Group A and Part 1b/Groups A-1/A-2 (itacitinib plus pembrolizumab), 74 (89.2%) patients in Part 1a/Group B and Part 1b/Groups B-1/B-2 (parsaclisib plus pembrolizumab), and 26 (96.3%) patients in Part 2 (parsaclisib plus pembrolizumab) discontinued treatment. Progressive disease (PD) was the most common reason for discontinuation in Part 1a/Group A [6 (75%)] and B [16 (47.1%)], Part 1b/Group A-1/A-2 [29 (70.7%)] and B-1/B-2 [30 (61.2%)], and Part 2 [13 (48.1%)]. AEs were also a common reason for treatment discontinuation of pembrolizumab in Part 1a/Group B [14 (41.2%)]. No patients remain on the study. Detailed patient disposition for each dose level evaluated in different treatment groups in Parts 1 and 2 are provided in 