Oh No, the Cuban Cancer Vaccine Is in the News Again!

The subject of cancer vaccines continues to be kept in the news. The world is also seeking the answer to this question, and not merely seeking it: it is examining and researching this issue, closely followed by the media, and trying to understand what it really means for patients… Cuba’s encounter with cancer continues to make headlines. Not just news, but a headline in one of Türkiye’s most respected newspapers. This time, “Cancer vaccine developed in Cuba is being tested in 39 cancer patients in Türkiye” was the headline…

So what will happen now? Let me say it straight away: thousands of cancer patients and their loved ones who read this will repeatedly visit their doctors. Interestingly, not only lung cancer patients but patients with almost every type of cancer and their loved ones will be affected by this news.

Let us look once again at the Cuban lung cancer vaccine in detail: to establish the benefit of the cancer vaccine called CIMAvax EGF, patients with inoperable and metastatic , meaning fourth-stage, non-small cell lung cancer—405 patients—were enrolled. All had previously received 4-6 cycles of conventional chemotherapy drugs (a platinum drug plus one of vinblastine, etoposide and paclitaxel) and had disease that regressed or remained stable. Of these patients, 270 received Cimavax, while 135 were observed without any treatment.

During follow-up, patients in the control arm lived an average of 8.8 months, while average survival in the vaccinated patient groups was 10.8 months. As seen, a 2-month extension of life was obtained.

Which Details of This Study Do Not Satisfy Us Scientifically?

First, in a reliable study, patient selection should be blinded, a placebo (drug-free) arm should be used, and selection should be performed by an independent group that does not see the patient. This matters because physicians assigning patients might place those in better general condition from the two groups in the vaccine arm, causing an erroneous result. This issue, which reflects study quality, is called patient selection bias (taking sides) and is a criterion that can profoundly affect the study result. The previous study by Alfonso and colleagues in Cuba scored poorly on the three most important of the 7 major criteria determining study reliability. Patient selection bias was one of these. Another issue is the mixed nature (heterogeneity) of the chemotherapy regimens patients received. Study groups received 3 different chemotherapy regimens, but some included drugs no longer preferred today, meaning less successful treatments were also used, without this being considered in the analysis. Another important issue is administering Pemetrexed, a drug with proven efficacy as switch maintenance—maintenance using a different drug after the initial chemotherapy regimen—approved by international guidelines and the FDA. When a treatment option demonstrating superior survival is available, how appropriate is it instead to have patients pay for an unconfirmed treatment that has not been compared with standard treatment and remains highly open to question?

Only One Group of Patients and a Chance of Short-Term Survival…

As seen, neither vaccine is currently close to being a solution for cancer. Examining them alongside scientific articles also shows that they are used only in one group of fourth-stage lung cancer patients and provide short-term benefit.

Many large-scale lung cancer vaccine studies in recent years have been disappointing (see our cancer vaccines and immunotherapy section). In particular, large clinical trials of lung cancer vaccines more specific than Cimavax, developed against proteins on the lung cancer cell surface called MAGE-A3, MUC-1, BLP25 and tecemotide, have also failed.

We believe that this Cuban study, published in August 2016 in Clinical Cancer Research, should also be viewed skeptically regarding its benefit in treatment-responsive stage 4 lung cancer patients: a 2-month contribution. The way the vaccine has been marketed worldwide also troubles many of us. Before the study data had fully matured, Cuban company representatives set off with their briefcases to market it worldwide, and sales and patient use began before the full study text was published.

In our review in July 2017, we see that this treatment method has not yet been considered in the American National Cancer Guidelines (NCCN) and European Cancer Treatment Guidelines (ESMO Guideline), nor offered as a feasible treatment recommendation. For maintenance called “Switch Maintenance,” in other words, if we want to continue with a different drug in patients with stage 4 lung cancer who benefited from first-line treatment, the most appropriate evidence-based approach currently is to use Pemetrexed.

In conclusion, based on the available scientific data, we do not consider it appropriate to have patients purchase and use the cancer vaccine called Cimawax brought from Cuba, either for lung cancer or other cancers. Through an agreement between Roswel Park Institute in America and Cuban researchers, clinical trials of this vaccine have begun, and we will follow developments on this subject for you in the coming years.

You May Be Interested In: Personalized cancer vaccinesoffer a more effective treatment option because they are developed specifically for the tumor.