Arcus Biosciences Presents Promising Initial Data from Phase 1 Portion of ARC-8 Study for AB680 in Metastatic Pancreatic Cancer
January 15, 2021 at 08:03 am EST
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Arcus Biosciences, Inc. presented preliminary data from the dose-escalation portion of its ARC-8 Phase 1/1b study, evaluating the safety and tolerability of AB680, the first small-molecule CD73 inhibitor to enter the clinic, in metastatic pancreatic cancer at the ASCO 2021 Virtual Gastrointestinal Cancers Symposium (ASCO GI). The ongoing, open-label, multicenter trial is a Phase 1/1b study evaluating the safety profile and clinical activity of AB680 in combination with nab-paclitaxel plus gemcitabine (NP/Gem) and zimberelimab, an anti-PD-1 antibody, as a first-line treatment in patients with metastatic pancreatic ductal adenocarcinoma (PDAC). Preliminary Safety Results (as of the safety DCO of Nov. 11th 2020 · 19 patients had received AB680 plus NP/Gem plus zimberelimab at doses of AB680 ranging from 25 to 100 mg, administered once every two weeks. · Across all four dose-escalation cohorts, no significant additive toxicity from AB680 plus NP/Gem plus zimberelimab has been observed beyond that expected from NP/Gem plus anti-PD-1 combined. · One dose-limiting toxicity (Grade 2 autoimmune hepatitis) occurred in the 50mg AB680 cohort; the event resolved completely with steroid treatment, and the patient resumed study treatment, including immunotherapy, without subsequent autoimmune events. · The most common treatment emergent adverse events (AE) were fatigue (68%), anemia (53%), alopecia (42%), diarrhea (42%) and neutrophil count decrease (42%). These AE results are very similar to
what would be expected with NP/Gem alone.
Arcus Biosciences, Inc. is a clinical-stage biopharmaceutical company developing differentiated molecules and combination therapies for people with cancer. The Company involves in a portfolio of investigational products, which are in clinical development with its advanced molecule, an anti-TIGIT antibody targeting lung and gastrointestinal cancers. The Company has approximately seven clinical programs that are focused on targets, including TIGIT, PD-1, adenosine A2a and A2b receptors, CD73, CD39, HIF-2a, and AXL. The Company is engaged in co-developing four investigational products, including zimberelimab (Arcuss anti-PD-1 molecule), domvanalimab (Arcuss anti-TIGIT antibody), etrumadenant (Arcuss adenosine receptor antagonist) and quemliclustat (Arcuss CD73 inhibitor). It is engaged in pursuing a Phase II and Phase III development program for domvanalimab in combination with its anti-PD-1 antibody, zimberelimab, in multiple settings, including lung and gastrointestinal cancer.