Optimism High for Mesothelioma Immunotherapy Clinical Trial in Europe
A novel clinical trial aiming to train the immune system to recognize and attack pleural mesothelioma tumor cells has opened with considerable optimism across five European countries.
The randomized phase II/III study is designed to measure the efficacy and anti-tumor activity of MesoPher, a vaccine combining a patient’s own dendritic immune cells with a specially engineered cell line.
The multicenter study, which is hoping for 235 participants, has opened in Antwerp, Belgium; Lille, France; Ancona, Italy; Amsterdam and Rotterdam, Netherlands and Leicester, England.
“There is hope, a lot of hope, with this study,” Dr. Dean Fennell, clinical trial principal investigator and professor of thoracic medical oncology at the University of Leicester, told The Mesothelioma Center at Asbestos.com. “Expectations are high, actually.”
Amphera, a biotechnology company focused on dendritic cell therapies for cancer, is developing MesoPher. The vaccine showed impressive results in an earlier phase I study.
Fennell, who is also director of the Mesothelioma Research Program at Leicester, uses a unique analogy when explaining to patients how the therapy works.
“I use the term sniffer dog, the kind you see at the airport. Those dogs are trained to recognize an odor, and then go after it,” he said. “That’s what we’re doing with the cells, first priming them outside the body to recognize what mesothelioma looks like, so when they go back into the body, they can orchestrate an immune response to attack the cancer.”
Vaccine Working After Chemotherapy
Dr. Joachim Aerts, at the Erasmus University Medical Center in Rotterdam, and another principal investigator, has pioneered the cutting-edge technology.
The randomized trial is designed as maintenance treatment after standard-of-care chemotherapy.
Patients in Arm A will receive three biweekly injections of MesoPher after chemotherapy, along with supportive care. They also will receive an additional injection at weeks 18 and 30.
Patients in Arm B will receive only supportive care after their chemotherapy.
Both arms also will receive Keytruda (pembrolizumab), another immunotherapy drug, after a comparative assessment of treatment in the two respective arms.
“What this [clinical trial] offers to a patient is the possibility of being able to control their tumor,” Fennell said. “I’d say there is a very, very good chance that we may see an extension of disease control, beyond the typical six months you see with chemotherapy.”
Pleural mesothelioma is a rare and aggressive cancer that starts in the lining around the lungs and is caused by exposure to asbestos.
Therapeutic advances have been slow coming. Standard-of-care treatment beyond chemotherapy hasn’t changed in almost 15 years.
Median survival after diagnosis is often estimated at just 12 months.
“Part of the problem has been the lack of randomized trials like this one,” Fennell said. “This is a well-designed study in which you will get answers.”
Reloading Immunotherapy Cells
The MesoPher treatment starts with collecting blood from patients using a standard hospital procedure.
Dendritic cells within the blood are isolated and reloaded with a laboratory prepared cell line designed to help the immune system identify and attack the cancer.
The final drug product is returned to the patient through a series of injections.
“With immunotherapy, there are several new approaches to treating cancer, which have real potential,” Fennell said. “And this is one of those.”
Horizon 2020 — the European Union’s research and development program — has helped fund the clinical trial.
In a smaller study, researchers are exploring MesoPher for use with peritoneal mesothelioma, a similar malignancy that starts in the lining of the abdomen.
Amphera already has secured the orphan-drug designation from the European Medicines Agency.
MesoPher was well tolerated in the earlier study with few serious side effects.
All patients exhibited an immunologic response with either stable disease or partial response.
“A study like this is absolutely critical to understanding the magnitude of benefit,” Fennell said. “We will learn, not only does it work, but by how much it works. I believe there is great potential with this one.”