Buffalo’s Roswell Park Cancer Institute has received approval from the Food and Drug Administration to conduct a clinical trial of an innovative lung cancer vaccine developed in Cuba.
Democratic Gov. Andrew Cuomo joined Roswell Park officials Wednesday to announce the trial, which is the first of its kind since the recent thaw in relations between the U.S. and Cuba.
Called CIMAvax-EGF, the treatment is an immunotherapy developed by Havana’s Center of Molecular Immunology. The trial will involve 60 to 90 patients and is expected to begin next month.
In a pilot study in Cuba, all patients given the vaccine have had advanced non-small cell lung cancer. The study is ongoing. In a follow-up study, the 80 patients in the Canadian trial, which opened last September, are being randomized to get or not get the vaccine. Vincent is not sure of definitive results. “We may find,” he said, “that our end-stage people with non-small cell lung cancer do not mount an immune response to anything because they are too immuno-depressed. If so, we may need to move to a randomized study of the vaccine in patients with slightly less advanced disease.”
In the current trial, however, detecting survival differences between the treated patients and the controls is secondary to assessing the vaccine’s safety and immunogenicity. It is not, Vincent indicated, that the Cuban findings on these scores are invalid; they are not. In fact, after a trip to Havana with a Canadian Medical Research Council group, he came away thinking that many of the scientists he met there “seemed quite good and could probably find employment anywhere in the western world.”