Arcus Biosciences has announced data from the Phase Ib ARC-8 study (NCT04104672) investigating quemliclustat in combination with zimberelimab, nab-paclitaxel and gemcitabine in participants with advanced metastatic pancreatic cancer.
In the 122-patient cohort, those who received 100mg of quemliclustat alongside chemotherapy as a first-line treatment, showed improved survival outcomes compared to historical benchmarks.
The study was relatively unique in that it included a synthetic control arm of patients treated with gemcitabine/nab-paclitaxel. The analysis was conducted by the Medidata artificial intelligence (AI), which is part of Medidata. External control arms or synthetic arms are used when the condition being studied has a small patient population or if there already exist large established datasets of randomised clinical trials in a particular area.
The quemliclustat group presented a 37% reduction in risk of death and a 5.9-month improvement in median overall compared to the matched control arm. The synthetic control arm consisted of patients treated with gemcitabine/nab-paclitaxel in previous Phase II and Phase III studies in the first-line setting. Other parameters like ECOG performance status, surgical history, presence of liver metastasis were also matched between the two arms.
The most common Grade 3 or higher side effects noted in subgroups that received quemliclustat were neutropenia and anaemia. While five deaths were reported in the study, the study investigators did not conclude they were linked to quemliclustat or Arcus’ PD-1 inhibitor zimberelimab, which was also part of the combination that one subgroup received.
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Arcus is conducting this study alongside Gilead Sciences, as part of a plan to study quemliclustat with other drugs under a collaboration.
Detailed results from the study will be presented at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco, US on 19 January.
According to a report on GlobalData’s Pharma Intelligence Center, the pancreatic cancer market in the eight major markets (8MM) of US, UK, France, Germany, Italy, Spain, Japan, and China is forecast to grow from $1.9bn in 2019 to $4.1bn in 2029 at a compound annual growth rate (CAGR) of 8.2%.
GlobalData is the parent company of Clinical Trials Arena.
In the announcement accompanying the data, principal investigator of the ARC-8 trial Zev Wainberg said: “A quemliclustat-based regimen appears to meaningfully prolong survival compared to what we typically observe in patients with mPDAC who receive chemotherapy alone, the standard of care for more than 30 years.
In August 2023, Arcus and Gilead terminated development for adenosine receptor antagonist etrumadenant after the drug failed to perform on radiographic progression-free survival (PFS) in a Phase Ib/II clinical trial evaluating the efficacy of combination therapy of etrumadenant, docetaxel, and zimberelimab, compared to docetaxel in patients with metastatic prostate cancer. The companies reported continued development of the drug for metastatic colorectal cancer.