Maintenance therapy with CIMAvax-EGF, a therapeutic cancer vaccine, significantly prolonged median survival time in patients with advanced non-small cell lung cancer (NSCLC) who completed induction vaccination, a study published in the journal Clinical Cancer Research has shown.1
For the phase 3 study, researchers enrolled 405 patients with stage 3b or 4 NSCLC who had received 4 to 6 weeks of first-line chemotherapy. Participants were randomly assigned to receive CIMAvax-EGF or placebo, plus best supportive care.
Results of this Cuban study showed that patients who received at least 4 vaccine doses achieved significant survival benefit compared with those in the control arm (HR, 0.82; P = .036).
Researchers found that median overall survival was 12.43 months in the vaccine arm vs 9.43 months in the control group. The study also demonstrated that median survival was longer (14.66 months) for vaccinated patients with high EGF concentration at baseline, suggesting that baseline EGF concentration predicts survival benefit.
CIMAvax-EGF, a first-of-its-kind vaccine, is composed of human-recombinant epidermal growth factor (EGF) conjugated to a carrier protein and Montanide ISA51, and is intended to induce antibodies against self EGF that inhibit the interaction between EGF and its receptor (EGFR).
The vaccine was developed in Cuba and is currently only available there; however, due to the thawing relationship between Cuba and the United States, American clinical trials with the vaccine are expected to begin in 2016.
- Rodriguez PC, Popa X, Martinez O, et al. A phase III clinical trial of the epidermal growth factor vaccine CIMAvax-EGF as switch maintenance therapy in advanced non-small-cell lung cancer patients [published online ahead of print February 29, 2016]. Clin Cancer Res. doi: 10.1158/1078-0432.CCR-15-0855.