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A phase 1b/2 study of INCB039110 + nab-paclitaxel (N) and gemcitabine (G) in patients (pts) with advanced solid tumors and pancreatic cancer (PC).

Authors: 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.

Affiliations: 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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