CINCINNATI—University of Cincinnati (UC) Cancer Institute researchers are testing the ability of a novel lung cancer vaccine to increase the body’s natural immune defense system against cancerous tumors.
This experimental immunotherapy—tergenpumatucel-L or HyperAcute-Lung—is being evaluated as part of a phase 2B/3 clinical trial offered at UC and Washington University in St. Louis. Approximately 50 patients are expected to enroll in the study locally, with up to 240 participating nationwide.
"Cancer vaccines have come in and out of favor since the 1950s due to limitations in the methods used to create vaccines,” says co-principal investigator of the study John Morris, MD. The current clinical trial—sponsored by NewLink Genetics Corporation—utilizes a novel approach: genetically altered lung cancer cells.
"To cause an immune response against a lung tumor and successfully destroy it, you need to vaccinate against something that exists specifically in lung tumor cells. The problem is we don’t know what most of those antigen targets are. People have been looking for decades and some have been pulled out—like HER2 in breast cancer—but most are unknown,” explains Morris, a UC College of Medicine lung cancer researcher and UC Health medical oncologist.
The experimental lung cancer vaccine being tested is based on lung cancer cell lines from the three most common forms of lung cancer. These cancer cells are altered to express a carbohydrate structure on their surface that is recognized as foreign by the immune system of humans and provokes a strong, targeted immune response in the body. This technology, known as HyperAcute immunotherapy, is being evaluated in multiple experimental and registration-driven clinical studies, including the HyperAcute-Lung Phase 2B/3 study of patients with progressive or relapsed stage IIIB/IV non-small cell lung cancer.
Clinical Trial Protocol
Study participants will be randomized into one of three treatment arms. Group 1 will receive standard chemotherapy (docetaxel, marketed as Taxotere) alone every three weeks. Groups 2 and 3 will receive the experimental lung cancer vaccine only—the first group receiving weekly injections, the second having injections every two weeks. Both experimental vaccine groups can receive up to 16 immunizations during the course of the clinical trial.
"Lung cancer is the leading cause of cancer-related deaths in the world, and the best chemotherapy treatments we can offer only increase lifespan by two to six months. Clearly we need to do better,” says Morris. "We are attempting to answer two questions with this trial: How does this vaccine compare head-to-head with the standard therapy (docetaxel) and if the patient gets the lung cancer vaccine and then progresses, will they have a better response to third-line chemotherapy?”
Patients will be closely monitored for signs of cancer regression or progression throughout the trial via physical examinations, blood tests and advanced medical imaging.
Morris, principal investigator of the UC-based arm of the study, has no financial interests in NewLink Genetics Corporation. There is no cost to patients for the experimental vaccine. Blood and laboratory tests that are required for the study and are done only for research purposes will also be paid by the study sponsor. Costs for standard medical therapy and non-research imaging/blood tests are the responsibility of the patient.
To learn more about this study, contact the UC Cancer Institute Clinical Trials Office at 513-584-7698. More information about cancer clinical trials open to enrollment can be found at uccancer.com/clinicaltrials