- Preliminary data from the first dose-escalation cohorts, reported in an abstract released today, demonstrate encouraging signs of clinical activity for AB680 in combination with zimberelimab (anti-PD-1 antibody) and chemotherapy

- Additional data, as of a cut-off date of December 9, 2020, to be presented at ASCO-GI on January 15th

HAYWARD, Calif.--(BUSINESS WIRE)-- Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company working to create best-in-class cancer therapies, today announced that preliminary data from the ongoing 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 combination with zimberelimab (anti-PD-1) and nab-paclitaxel plus gemcitabine (chemotherapy) in front-line metastatic pancreatic cancer will be presented in a poster session at the ASCO 2021 Virtual Gastrointestinal Cancers Symposium (ASCO GI) being held January 15th – 17th, 2021.

“While recent cancer breakthrough therapies, most notably anti-PD-1 antibodies, have led to dramatic improvements in outcomes in many cancer settings, this is not the case for pancreatic cancer, which remains a devastating diagnosis for patients. We are highly encouraged by the preliminary data from our Phase 1 trial for AB680 in combination with anti-PD-1 therapy and chemotherapy, in which we have seen promising clinical activity in these difficult to treat patients. Importantly, this experimental regimen has been well tolerated, and early safety data indicate that this AB680 combination regimen appears to have a side effect profile similar to that of anti-PD-1 therapy and chemotherapy,” said Bill Grossman, M.D., the Chief Medical Officer of Arcus. “We look forward to presenting updated data from the Phase 1 portion of this trial at ASCO GI on January 15th, wherein we will report more mature safety and clinical response data, including those from the 100mg dose cohort.”

The clinical activity and safety profile observed to date with AB680 in combination with zimberelimab (anti-PD-1 antibody) and chemotherapy support its recent advancement into the ongoing Phase 1b expansion portion of the study, as well as plans to open a randomized control arm for the Phase 1b expansion. Dosing of AB680 100mg I.V. every two weeks has been selected for this portion of the study.

Full details of the presentation are as follows:

Abstract/Poster Title: ARC-8: Phase I/Ib study to evaluate safety and tolerability of AB680 + chemotherapy + zimberelimab (AB122) in patients with treatment-naive metastatic pancreatic adenocarcinoma (mPDAC) Abstract No: 404 Poster Session: Pancreatic Cancer Available Date: January 15, 2021 Time: 5:00 a.m. PT

In addition to the presentation on AB680, Arcus will also highlight the design of the recently initiated ARC-9 randomized Phase 2 study to advance etrumadenant in late-line colorectal cancer:

Abstract/Poster Title: ARC-9: Phase Ib/II study to evaluate etrumadenant (AB928)-based treatment combinations in patients with metastatic colorectal cancer (mCRC) Abstract No: TPS150 Trials in Progress Poster Session: Colorectal Cancer Available Date: January 15, 2021 Time: 5:00 a.m. PT

Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of cancer-related deaths in Europe and the United States1 and the seventh leading cause of cancer-related deaths worldwide2.

Pancreatic ductal adenocarcinoma (PDAC) is the most prevalent neoplastic disease of the pancreas, with high metastatic potential, accounting for more than 90% of all pancreatic malignancies and is a highly devastating disease with poor prognosis and rising incidence.3,4

Few treatment options exist for metastatic pancreatic cancer, and response rates to the standard of care therapy of gemcitabine/nab-paclitaxel remain very low. Based on the FDA approved label for nab-paclitaxel in combination with gemcitabine, the phase 3 registrational trial demonstrated overall and complete response rates in patients with metastatic pancreatic cancer that were 23% and