Cuba's Lung Cancer Vaccine: Hype or Hope?

Roxanne Nelson, BSN, RN

August 26, 2016

Now that relations between the United States and Cuba are thawing, there has been a growing interest in forming medical partnerships.

Of particular interest is a lung cancer vaccine called CimaVax, which was developed for non-small cell lung carcinoma. Available in Cuba since 2011, the vaccine has caught the attention of researchers and physicians not only in the United States but in other countries as well.

But while intriguing, the question remains: Is it really a breakthrough in lung cancer treatment?

Since last year, enticing headlines have been cropping up across the mainstream media. One recent news story from a local affiliate of Fox News, for example, ran with the provocative title that "Cuba Announces Breakthrough Cancer Drug" and then went on to say that "It's a medical breakthrough that could literally save millions of lives."

According to the story, the vaccine has "been shown to significantly increase life expectancy" and is "cheap and it seems to be effective for a lot of patients."

It would be wonderful news for patients with lung cancer if this were all true, but this article just seems to be another instance of sensationalism run amok, according to HealthNewsReview, a watchdog group that evaluates and grades daily health news reporting by major US news organizations.

The Fox News story provides no evidence to support any of the "sweeping claims," they make, writes Kevin Lomangino, managing editor of HealthNewsReview.

What the Fox News story did get right is that the vaccine is cheap; it costs about $1 per vaccine and is offered for free in Cuba, where it has been available for about 5 years.

But it is not likely to be available in the United States anytime soon. At present, discussions about clinical trials are ongoing. Roswell Park Cancer Center in Buffalo, New York, is collaborating with Cuban researchers and going through the rigors of regulatory approval so that they can eventually begin enrolling patients and conduct a clinical trial.

What Is CimaVax?

Primarily because of the trade embargo placed on the island nation by the United States in the 1960s, the impression of Cuba is often one of isolation and economic struggle. However, at least when it comes to biotechnology and medicine, Cuba's industry is flourishing.

Established in the early/mid-1980s, the Cuban biotech industry has, among other things, developed a meningitis B vaccine, exported a hepatitis B vaccine to more than 30 countries, and developed the first synthetic vaccine for the prevention of pneumonia and meningitis, at a cost much lower than what was being offered by United States and European manufacturers.

Overall, the biotech industry in Cuba holds about 1200 international patents and markets pharmaceutical products and vaccines all over the world. It is not surprising that anticancer therapeutics are on the list because cancer is the second leading cause of death in Cuba. Also not surprising, given that the country is famous for its fabled cigars, is that lung cancer is at the top of the killer list for men.

CimaVax targets the epidermal growth factor receptor (EGFR), which is overexpressed in approximately 40% to 80% of non-small cell lung cancers (NSCLCs). EGFR overexpression is associated with poor prognosis, lower survival, and resistance to therapy in cancer, and the vaccine's mechanism of action is to prevent binding of the endogenous EGF to the receptors.

The vaccine has been in development for 25 years, and studies have shown a survival advantage, although not game changing, at least in its present form. To date, it has been administered to about 5000 patients worldwide in clinical trials, including 1000 Cubans.

An early phase 2 trial in patients with stage IIIB/IV NSCLC showed that immune response strongly correlated with survival (J Clin Oncol. 2008;26:1452-1458). Among patients who had been vaccinated, those with a good anti-EGF antibody response had significantly better survival that those who did not show such a response, and there was also a significant survival difference between vaccinated and nonvaccinated persons in a subgroup of patients who were younger than 60 years of age.

A more recent phase 3 trial, also in patients with advanced disease, showed a significant improvement in median overall survival in patients who were vaccinated (12.43 months vs 9.43 months in the control group) (Clin Cancer Res. 2016;22:3782-3790). The researchers noted that the median survival (14.66 months) was longer in vaccinated patients who had high EGF concentration at baseline.

Collaboration With Roswell Park

In 2011, researchers from the Roswell Park Cancer Institute began working with researchers at the Center for Molecular Immunology in Havana. In 2015 a deal was reached to bring CimaVax to the United States for US Food and Drug Administration inspection and eventually clinical trials.

Grace Dy, MD, a thoracic medical oncologist at Roswell Park and the principal investigator in the upcoming trial, commented in an interview that in Cuba, treatment options for lung cancer were limited.

"So they developed a relatively inexpensive therapy, and saw a benefit in patients who developed a good antibody response to circulating EGFR," she told Medscape Medical News.

The objective of the clinical trials at Roswell Park will be to validate these observations, to measure circulating EGFR and antibody response, and to "independently assess if we see similar outcomes in our own population," she noted.

But Dr Dy emphasized that it is "tricky to develop it in the same setting, since we have many more treatment options, so we need to change the clinical trial design."

At Roswell Park, the plan is to combine it with nivolumab (Opdivo, Bristol-Myers Squibb) and see how the vaccine will modulate the effect of checkpoint inhibitors.

The trial will be a phase 1/2 study, with the first phase being dose escalation for the vaccine. "Once we determine the dose, we will then investigate the combination and look at the 1-year outcomes," she said.

What remains now is getting through the various review and regulatory processes, Dr Dy said. "We have to go through the regulatory processes to bring the drug over from Cuba, and then get it approved for use in US trials," she noted. "We have submitted the necessary paperwork on our end."

Dr Dy is hopeful that they may be able to begin enrolling patients within the next few months, but they do not have a set date for when the regulatory process will be completed.

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