Part 1: Parsaclisib plus Pembrolizumab
NSCLC, pneumonitis, DLTs, TEAEs, depressed, oliguria
PNEUMONITIS, NSCLC, OLIGURIA
One 72-year-old patient with NSCLC in Part 1a/Group B (receiving parsaclisib 2.5 mg once daily plus pembrolizumab) experienced two grade 4 DLTs of pneumonitis (day 12, considered related to pembrolizumab and parsaclisib; not resolved) and oliguria (day 14, considered related to parsaclisib; fatal). No patient in Part 1b/Group B-1 [PD-(L)1 treatment-experienced] or B-2 [PD-(L)1 treatment-naïve] experienced a DLT. All patients in Part 1 treated with parsaclisib experienced ≥1 TEAE (A total of 50 patients experienced ≥1 serious TEAE [23 (67.6%) in Part 1a/Group B, 27 (55.1%) in Part 1b/Group B-1/B-2] (Fifteen patients (44.1%) in Part 1a/Group B experienced TEAEs leading to discontinuation of parsaclisib, and 14 patients (41.2%) had TEAEs leading to discontinuation of pembrolizumab. TEAEs leading to treatment discontinuation occurred in 1 (2.9%) patient each except for increased alanine aminotransferase, increased aspartate aminotransferase, and depressed level of consciousness [each 2 (5.9%)]. Nine patients (18.4%) in Part 1b/Group B-1/B-2 experienced TEAEs leading to discontinuation of parsaclisib, and 8 patients (16.3%) had TEAEs leading to discontinuation of pembrolizumab.