The Food and Drug Administration has approved the first clinical trial to test a Cuban drug in the United States — a lung-cancer vaccine developed in Havana.
The decision on the early-stage trial was announced Wednesday by New York Gov. Andrew Cuomo (D) and officials at the Roswell Park Cancer Institute, based in Buffalo. The trial could start as soon as next month and will enroll 60 to 90 patients. It is likely to take three years to complete.
The trial will test the CIMAvax-EGF vaccine, combined with an immunotherapy drug called Opdivo, which has already been approved in the United States. The goal is to see if the pairing improves effectiveness.
Cuomo touted the fact that the FDA's action stemmed from the boost in a research partnership between Roswell and Cuba's Center of Molecular Immunology (CIM) that occurred during a New York state trade mission last year. About two months later, the United States formally restored diplomatic relations with Cuba after a half-century breach.
Lung cancer is the leading cause of cancer deaths in the United States, with a five-year survival rate of only 17 percent. According to Grace Dy, the principal investigator in the Roswell Park trial, "We're at an early stage in the development of this vaccine, which has never before been given to U.S. patients, so we have a lot to learn through this study. But the evidence so far is encouraging."
The vaccine developed by CIM has been approved by a number of countries, including Paraguay and Peru. Even so, Len Lichtenfeld, deputy chief medical officer at the American Cancer Society, has taken a cautious stance on the vaccine.
In a post in March that society officials said was still relevant, he noted that “currently we do not have the information we need to have to know whether or not this vaccine could be useful in treating lung cancer or possibly be used to prevent cancer in patients at high risk of developing lung cancer. The studies that have been reported from Cuba are small and have limitations that prevent us from knowing how the treatment could be applied to the typical patient with lung cancer."
He said that the history of vaccines in treating cancer has shown many more failures than success, making "the need to undertake well-designed clinical trials all the more important."