ASCO GI 2017: INCB039110 116
A phase 1b/2 study of INCB039110 + nab-paclitaxel (N) and gemcitabine (G) in patients (pts) with advanced solid tumors and pancreatic cancer (PC).
Gregory Beatty,1 Safi Shahda,2 Thaddeus Beck,3 Nikhil Uppal,4 Steven J. Cohen,5 Ross Donehower,6 A. Eli Gabayan,7 Albert Assad,8 Julie Switzky,8 Huiling Zhen,8 Daniel Von Hoff9.
1Hospital of the University of Pennsylvania, Philadelphia, PA; 2Indiana University Melvin and Bren Simon Cancer Center, Indianapolis, IN; 3Highlands Oncology Group, Fayetteville, AR; 4NYU Langone Arena Oncology, Lake Success, NY; 5Fox Chase Cancer Center, Philadelphia, PA; 6The Johns Hopkins Medical Institutions, Baltimore, MD; 7Beverly Hills Cancer Center, Beverly Hills, CA; 8Incyte Corporation, Wilmington, DE; 9Translational Genomics Research Institute (TGen) and HonorHealth, Phoenix and Scottsdale, AZ.
ClinicalTrials.gov identifier: NCT01858883
Character count of abstract body (including title, body, tables): 1990 (limit, 2,000)
Topic category (selected from list): Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Presentation preference: poster presentation
A phase 1b/2 study of INCB039110 + nab-paclitaxel (N) and gemcitabine (G) in patients (pts) with advanced solid tumors and pancreatic cancer (PC)
BACKGROUND: JAK-STAT activity has been associated with malignant cell proliferation and production of proinflammatory cytokines involved in cancer progression. INCB039110 is a potent and selective inhibitor of JAK1.
METHODS: This was a 2-part phase 1b/2 open-label study evaluating INCB039110 (300 or 400 mg QD) in combination with N and G in pts with advanced or metastatic solid tumors (Part 1 [P1], dose optimization phase) and pts with advanced or metastatic PC who had not received prior chemotherapy (Part 2 [P2] and 2A [P2A]). Pts in P2 received the MTD established in P1: INCB039110 (300 mg QD) + N (125 mg/m2 day [d] 1, 8, 15) + G (1000 mg/m2 d 1, 8, 15), 28-d cycle. For exploratory purposes, pts in P2A underwent a 7-d induction phase with INCB039110 (200 mg QD) before receiving INCB039110 (200 mg QD) + N (125 mg/m2 d 1, 8, 15) + G (1000 mg/m2 d 1, 8, 15). The primary objective was to evaluate safety/tolerability.
RESULTS: 55 pts were enrolled (27 P1, 20 P2, and 8 P2A). Most patients had advanced PC (n=46). Median age was 65 (P1), 67 (P2), and 66 years (P2A). Prior therapy: 67% in P1, 30% in P2, and 0% in P2A. The most common reasons for treatment discontinuation were adverse events (AEs; 41% P1, 20% P2, 38% P2A), disease progression (37% P1, 45% P2, 0% P2A), and study termination by the sponsor (0% P1, 0% P2, 38% P2A). Median treatment durations were 84 d (P1), 121 d (P2), and 47 d (P2A). The most common non-hematologic AEs (all grades) were fatigue (59% P1, 75% P2, 88% P2A), nausea (41% P1, 50% P2, 38% P2A), pyrexia (37% P1, 40% P2, 13% P2A), and peripheral edema (30% P1, 50% P2, 25% P2A), with few grade 3 or 4 non-hematologic AEs. The most common grade 3 or 4 hematologic AEs (laboratory values) were neutropenia (33% P1, 60% P2, 13% P2A), lymphopenia (30% P1, 30% P2, 13% P2A), and leukopenia (30% P1, 45% P2, 0% P2A). The most common serious AEs occurring in ≥3 pts were pneumonia (n=4 P1, n=2 P2, n=0 P2A) and anemia (n=3 P1, n=2 P2, n=2 P2A). Among evaluable patients, ORR (all PRs) and DCR were 27% (13/48) and 75% (36/48), respectively. Responses were seen across INCB039110 doses.
CONCLUSIONS: INCB039110 + N/G showed an acceptable safety profile in pts with advanced PC, with the combination demonstrating clinical activity.
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