Arcus Biosciences, Inc. announced promising overall survival data from the ARC-8 Phase 1b trial, co-developed with Gilead Sciences. The trial studies quemliclustat, an investigational CD73 inhibitor, combined with chemotherapy—with or without zimberelimab, an anti-PD-1 antibody—in previously untreated patients with metastatic pancreatic ductal adenocarcinoma (mPDAC). The results are scheduled to be presented at the ASCO GI Symposium in 2024.
Dr. Zev A. Wainberg from the University of California Los Angeles highlighted the apparent survival benefit of quemliclustat plus standard chemotherapy, relative to chemotherapy alone, which has been the standard of care for more than 30 years. He noted CD73’s high expression on pancreatic cancer cells and the potential of inhibiting CD73 to improve outcomes in mPDAC.
Data from all patients (n=122) treated with 100mg quemliclustat regimens were compared to a Synthetic Control Arm (SCA) constructed post-hoc by Medidata AI. This matched analysis, based on demographic and key baseline characteristics, indicated that ARC-8 patients experienced longer survival than the control arm. The efficacy data for quemliclustat-based regimens were also numerically greater than the historical benchmark for chemotherapy alone, with median overall survival (mOS) rates higher than the approximately nine-month survival seen historically.
The pooled dose-escalation, dose-expansion, and randomized arms data showcased a mOS greater than the SCA, with hazard ratios indicating a positive trend in survival. The ARC-8 patients exhibited a 12-month OS of 62.7% compared to 41.1% in the SCA, and median PFS was extended in the ARC-8 group. The percentages of objective response rate (ORR) between the treatment group and SCA were comparable.
This trial advancement suggests quemliclustat-based regimens may offer a significant survival benefit for mPDAC patients, potentially altering the treatment landscape for this aggressive cancer.
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