Lung Cancer Treatment Shows Promise With TG4010 and CIMAvax-EGF Vaccine Therapies

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Two vaccine therapies, TG4010 and CIMAvax-EGF, show promise for treating lung cancer.
Two vaccine therapies, TG4010 and CIMAvax-EGF, show promise for treating lung cancer.

In 2017, an estimated 222,500 Americans will be diagnosed with lung cancer — 13% of all newly diagnosed cancers. In the same year 155,870 Americans will die of the disease, accounting for about 26% of all cancer deaths overall, according to the National Cancer Institute.1 The 5-year overall survival rate for lung cancers is 18%.

Overall, incidence rates have declined about 2% per year over the past decade and death rates have declined at about the same rate.

Investigational monotherapies and combinatorial immunotherapies may help to improve these outcomes and are under investigation, including chimeric antigen receptor (CAR) T cell therapies, immune checkpoint inhibitors, and cancer vaccines.2,3

Efforts to develop lung cancer vaccines began more than 20 years ago but have met with disappointment. Clinical trials for at least 7 therapeutic vaccines were initiated against non–small cell lung cancer (NSCLC) in the United States but, to date, most have failed to yield clear evidence of efficacy, at least in part because of insufficient immune activation against lung tumors.4-6

Large phase 3 clinical trial results dashed hopes for 3 different NSCLC vaccines that showed promise in phase 2 trials: MAGE-A3, tecemotide, and belagenpumatucel-L.5

Two other NSCLC vaccines — TG4010 and CIMAvax-EGF — may be long-awaited advances in this field.7-9

TG4010 is an attenuated, recombinant vaccinia virus that expresses interleukin 2 and the tumor-expressed antigen MUC1.7 The CIMAvax-EGF vaccine was developed in Cuba, where it is now approved for use. It is a recombinant conjugate vaccine with human epidermal growth factor (EGF) attached to a carrier protein.8,10,11

Both vaccines show promise in clinical studies.

In a phase 2b component of the TIME study (ClinicalTrials.gov Identifier: NCT01383148), adding TG4010 to standard frontline chemotherapy improved progression-free survival (PFS) among patients with advanced NSCLC (5.9 months vs 5.1 months in placebo-group patients) — without serious grade 3 or 4 vaccine-related adverse reactions.7

CIMAvax-EGF induces immune responses against EGF to block cancer cell proliferation.10 Already used to treat more than 5000 patients in Cuba, CIMAvax-EGF is under study in combination with nivolumab at Roswell Park Cancer Institute in Buffalo, New York, in collaboration with the Center of Molecular Immunology in Cuba.9 The binational, 2-part phase 1/2 study (ClinicalTrials.gov Identifier: NCT02955290) was initiated in January 2017, enrolling patients with advanced, previously treated NSCLC.12

RELATED: Alectinib Beats Crizotinib in ALK-positive Non-small Cell Lung Cancer

“We are hoping to assess whether these 2 immunotherapies are more effective when given together as a combination,” principle investigator Grace Dy, MD, Roswell Park's chief of thoracic oncology told Cancer Therapy Advisor. “We expect that the study will enroll somewhere between 60 and 90 patients total and will take approximately 3 years to complete.”

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