Part 1: Itacitinib plus Pembrolizumab
NSCLC, SCLC, primary pancreatic carcinoma, TEAEs, pain, pyrexia, chills
NON-SMALL CELL LUNG CANCER, SCLC, UROTHELIAL CARCINOMA, MALIGNANT NEOPLASM PROGRESSION, SMALL CELL LUNG CANCER, DRUG-INDUCED LIVER INJURY, ADVERSE EVENT, NSCLC
No patient in Part 1a/Group A, or Part 1b/Group A-1 [PD-(L)1 treatment-experienced] or A-2 [PD-(L)1 treatment-naïve] experienced a DLT. All patients in Part 1 treated with itacitinib experienced ≥1 TEAE (Summary of itacitinib and parsaclisib treatment-related TEAEs by MedDRA preferred term (≥5% of patients in the safety population)Abbreviations: MedDRA, Medical Dictionary for Regulatory Activities; NSCLC, non-small cell lung cancer; Q3W, every 3 weeks; QD, once daily; SCLC, small cell lung cancer; TEAE, treatment-emergent adverse event; UC, urothelial carcinoma.
A total of 26 patients experienced ≥1 serious TEAE [6 (75.0%)] in Part 1a/Group A, and 20 (48.8%) in Part 1b/Group A-1/A-2 (Serious TRAEs considered related to pembrolizumab were reported in one patient in Part 1b/Group A-1 [chills and pyrexia (each 2.4%)], and considered related to itacitinib were reported in 2 patients in Part 1b/Group A-1/A-2 [pyrexia in 2 (4.9%) patients, and chills in 1 (2.4%) patient]. No serious TEAE reported in Part 1a/Group A were considered related to either pembrolizumab or itacitinib. Two patients in Part 1b/Group A-2 [PD-(L)1 treatment-naïve] had TEAEs of special interest, with laboratory results that met the criteria for potential drug-induced liver injury; neither patient met Hy’s Law criteria. TEAEs of grade ≥3 were reported in 7 patients (87.5%) in Part 1a/Group A and in 27 (65.9%) of patients in Part 1b/Group A-1/A2.Treatment was discontinued in 1 patient (12.5%) in Part 1a/Group A because of a TEAE of back pain. Both itacitinib and pembrolizumab were discontinued in 10 patients (24.4%) in Part 1b (2 patients in Group A-1 and 8 patients in Group A-2) because of TEAEs; 4 of the 10 patients discontinued because of malignant neoplasm progression. In Part 1b/Group A-2, 1 patient had itacitinib discontinued on day 153 (because of pyrexia), and pembrolizumab discontinued on day 184 (because of bilateral pulmonary emboli associated with progression of primary pancreatic carcinoma).