Research and clinical trials
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A research team at Oslo University Hospital in Norway has opened a clinical trial for mesothelioma using the new UV1 cancer vaccine combined with a promising combination of immunotherapy.
UV1 is a peptide-based vaccine designed to induce a specific T-cell response and increase the effectiveness of immunotherapy drugs.
This is the first time that UV-1 has been studied with mesothelioma cancer, but it has already shown signs of safety and efficacy when used in malignant melanoma, prostate cancer and lung cancer in studies worldwide.
It will be used in combination with the immunotherapy combination of nivolumab and ipilimumab, also known by the brand names Opdivo and Yervoy, respectively.
UV1 is a product of Ultimovacs, a pharmaceutical company based in Oslo, Norway. The study will soon move to six other national hospitals, covering Sweden, Spain, Denmark and Australia.
“Even if we can’t promise efficacy at this point, we believe mesothelioma is a closely related cancer to test for this vaccine,” Dr. Jens Bjorheim, Ultimovacs’ chief medical officer, told Asbestos.com’s Mesothelioma Center. “The hope is the clinical efficacy and overall survival benefit.”
Pleural mesothelioma patients are part of the trial
A phase II, randomized study includes treatment in a second-line setting after tumor progression with first-line chemotherapy for those with irreversible disease.
Bristol-Myers Squibb, the pharmaceutical giant that produces the immunotherapy blend, is one of the study participants.
The first patient underwent a dose on 15 June. The study is expected to reach the efficacy end point in 2022 and include 118 patients with pleural mesothelioma. Half will get only nivolumab and ipilimumab – known as checkpoint inhibitors – and the other half will also be treated with a cancer vaccine.
The researchers believe there is a synergistic effect when the vaccine is used with checkpoint inhibitors.
UV1 works by targeting telomerase, a cancer antigen that helps cancer cells divide uncontrollably. By targeting telomerase, the immune system can better recognize and destroy cancer cells.
“The vaccine helps the immune system do its job,” Beerheim said. “Hopefully, the vaccine will boost what the immune system is designed to do – kill cancer cells.”
The immunotherapy combination of nivolumab and ipilimumab has already shown promising results in previous trials with pleural mesothelioma.
At the World Lung Cancer Congress annual meeting in August, the authors of a first-line immunotherapy study demonstrated increased survival of mesothelioma patients when comparing the nivolumab/ipilimumab combination with standard chemotherapy.
Although the median overall survival advantage was modest—18.1 months compared to 14.1 months—it was even more dramatic for those with the traditional subtypes of more difficult-to-treat mesothelioma.
For patients with non-epithelial tissue, median survival was only 8.8 months with standard chemotherapy, but 18.1 months for those receiving the combination immunotherapy. The overall survival rate was 38% for the immunotherapy group and only 8% for the chemotherapy group.
Mesothelioma is an aggressive cancer that often results from long-term exposure to asbestos. There is no definitive cure for mesothelioma, despite recent therapeutic advances. It is diagnosed in about 3,000 people annually in the United States, and about 20% of people with pleural mesothelioma — which begins in the thin lining around the lungs — live three years after diagnosis.
Immunotherapy is the future of mesothelioma care
Like most of the medical community, Bjorheim believes the future of cancer care involves the use of immunotherapy. However, finding the right constructs has been challenging, especially for rare cancers such as mesothelioma.
UV1 was part of another clinical trial involving malignant melanoma and was combined with pembrolizumab, also known as Keytruda, a different checkpoint inhibitor drug.
“There are a large number of formulations that are being tested today,” Beuerheim said. “Some are different types of immunotherapy, and some are immunotherapy combined with older type therapies. Immunotherapy has, in a way, revolutionized cancer care in the past decade.”
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