Scandinavian-based Targovax launched the latest immunotherapy clinical trial for pleural mesothelioma, hoping it delivers a better way to treat patients with asbestos-related diseases.
The randomized phase Ib/II trial evaluates the performance of ONCOS-102, an engineered human adenovirus designed to induce systemic, anti-tumor responses.
Researchers are administering the immunotherapy drug as first-line therapy in combination with chemotherapy using pemetrexed and cisplatin.
“Based on what we've seen in our first study of patients with various solid tumor types, which is good tolerance and response in a couple of mesothelioma patients, we're quite hopeful for something positive from this trial,” Dr. Magnus Jaderberg, chief medical officer at Targovax, told Asbestos.com. “There is a lot of excitement.”
Doctors will inject ONCOS-102 directly into the tumor lesions of the pleura, the thin lining around the lungs. Each patient in the multicenter trial will receive six treatments in a five-month period. The trial involves 30 mesothelioma patients.
How Does ONCOS-102 Work?
The virus is engineered to replicate only in tumor cells while leaving normal cells unharmed.
That process breaks down cancer cells, which release specific tumor signals picked up by immune cells. Those immune cells then find and attack the tumor.
Because ONCOS-102 is derived from an adenovirus, it produces minor flu-like symptoms, such as chills and fevers, which may last a few days.
Impressive Tumor Reduction in Early Phase
The clinical trial's first patient in Barcelona, Spain, received his initial immunotherapy dosage in June. France, Italy and the U.K. also are serving as host sites for the clinical trial.
Optimism about the drug stems partially from an earlier phase I trial in Finland involving various solid tumors and progressive disease that no longer responded to chemotherapy.
ONCOS-102 elicited a 40 percent disease stabilization rate across all tumor types in that trial. The study group included two mesothelioma patients who responded well. One of those patients showed a 47 percent reduction in tumor size.
Also in Finland, a compassionate-use program of ONCOS-102 that allowed access to the yet unapproved drug included 115 patients with various solid tumors such as mesothelioma. Because it was not a controlled study, there were no definitive conclusions, but Jaderberg reported patients exhibited good tolerance and clinical responses to the drug.
Last summer, a preclinical animal study involving mesothelioma tumor cells also demonstrated synergy between ONCOS-102 and the same chemotherapy combination.
“Mesothelioma is known as a highly malignant disease which is usually diagnosed too late for surgery, and as a result, there is very little that patients can be treated with,” Jaderberg said. “New therapies are needed. We hope our immunotherapy can provide additional benefit to standard of care chemotherapy.”
Currently, the U.S. Food and Drug Administration has no approved second-line treatments for mesothelioma patients with unresectable disease.
Immunotherapy Critical to the Future of Cancer Treatment
The phase I study induced tumor specific immune activation at systemic and lesional levels linked to clinical benefit.
Most medical professionals believe the future of cancer care rests in immunotherapy drugs that use a patient's own immune system to fight off disease. There are dozens of immunotherapy drugs now in the developmental pipeline.
Patients generally tolerate immunotherapy drugs well and without the harsh side effects of typical chemotherapy. These drugs initially complement traditional multidisciplinary treatment that may include surgery, radiation and chemotherapy.
Targovax also is planning to launch trials of ONCOS-102 later this year for melanoma, prostate cancer and ovarian cancer. The melanoma and ovarian cancer trials will include sites within the United States.
“Based on data we have generated so far, I would say there is a good chance that we will find solid tumors where we will show enhanced efficacy,” he said. “I hope one of those will be mesothelioma.”