Quemliclustat named orphan drug by FDA for pancreatic cancer
Arcus Biosciences' Phase 3 trial recruiting in North America, Europe, Asia
Quemliclustat has been granted an orphan drug designation in the U.S. as a potential treatment for pancreatic cancer.
The U.S. Food and Drug Administration gives this designation to provide extra incentives for companies that are investing in developing treatments for rare diseases, or disorders that affect 200,000 or fewer people in the U.S. The companies are eligible for perks including tax breaks, fee waivers, and a guarantee of seven years market exclusivity if their therapy is ultimately approved.
“The orphan drug designation indicates the importance of developing new treatment options for rare diseases like pancreatic cancer, which has the highest mortality rate of all major cancers, and which has seen few treatment advancements over the past 30 years,” Richard Markus, MD, PhD, chief medical officer at Arcus Biosciences, the company developing quemliclustat, said in a press release.
Quemliclustat designed to block CD73 to help immune system kill cancer cells
Quemliclustat is designed to block the activity of CD73, a protein that cancer cells often use to help evade the immune system. By blocking this protein, the therapy aims to help unleash the immune system to destroy cancer cells.
In a Phase 1 study called ARC-8 (NCT04104672), most pancreatic cancer patients given quemliclustat in addition to chemotherapy lived at least 15 months, with median survival time exceeding what has historically been seen for pancreatic cancer patients given chemotherapy alone.
Arcus is now running a Phase 3 clinical trial called PRISM-1 (NCT06608927), which is recruiting 610 people with pancreatic ductal adenocarcinoma (PDAC), the most common form of pancreatic cancer. The study is open to adults whose cancer is metastatic — or has spread to other parts of the body — and has not been treated previously as metastatic.
All participants in PRISM-1 will be given a standard regimen of chemotherapy using the drugs gemcitabine and nab-paclitaxel. Some participants will also be treated with quemliclustat, while others will be given a placebo instead. The study’s main goal is to see if quemliclustat is better than the placebo at extending overall survival over a period of up to 72 months (6 years).
The Phase 3 trial is currently recruiting participants at sites in North America, Europe, and Asia.
“We expect the Phase 3 PRISM-1 study to be fully enrolled this year and, if positive, intend to quickly bring this new first-line treatment option to patients, with the goal of prolonging survival for those with metastatic pancreatic cancer,” Markus said.
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