Mesothelioma patients could have a new first-line treatment if the Food and Drug Administration (FDA) approves a mesothelioma immunotherapy vaccine.
The ONCOS-102 immunotherapy vaccine was developed by Norwegian biotech company Targovax.
Unlike chemotherapy, immunotherapy is meant to increase the strength of the immune system response to disease.
When combined with standard chemotherapy - pemetrexed (brand names: Alimta) and cisplatin - ONCOS-102 produced a median overall survival rate of 18.2 months, four months higher than the control group receiving chemotherapy alone.
31 patients, from Spain and France, were involved in the study. 20 of these patients received the vaccine/chemotherapy combination. ONCOS-102 was given by injection on days one, four, eight, 36, 78, and 120 of the clinical trial. The chemotherapy combination was administered every 21 days starting on day 22 of the clinical trial.
At 18 months, more than half of the 31 patients were still alive. Few side effects were reported, aside from what is normally expected with chemotherapy. The researchers also found evidence that the patients who received the vaccine/chemotherapy combination had strengthened immune systems.
Historical data shows that mesothelioma patients who receive only chemotherapy treatment for their disease have a median overall survival rate of 12 months involving all of the unpleasant side effects associated with chemotherapy, which attacks healthy cells, as well as the cancer cells.
ONCOS-102, however, has been specifically engineered to only attack cancer cells, which, when combined with standard chemotherapy for mesothelioma, will reduce the unpleasant side effects of chemotherapy.
If ONCOS-102 is approved by the FDA to treat mesothelioma, it will be the third treatment approved by the agency to treat mesothelioma in 2020. Prior to the FDA’s October 2020 approval of Opdivo and Yervoy for the treatment of mesothelioma, there had not been a new drug regimen approved for mesothelioma in the past 16 years. Both Opdivo and Yervoy were approved by the FDA after showing four-month improvements, just as ONCOS-102 has.
Targovax also plans to start a new clinical trial spread across the United States and Europe, in which ONCOS-102 will be combined with Keytruda (pembrolizumab), manufactured by Merck & Co. Keytruda has received limited FDA approval in the treatment of mesothelioma patients whose disease has progressed following prior treatment and who have no alternative treatment options.
Targovax’s new clinical trial is expected to start in early 2021.
Watch Targovax’s virtual presentation of their clinical trials’ findings from Dec. 2.
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