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

EGFR is a well-validated target for patients with non-small cell lung cancer (NSCLC). CIMAvax-EGF is a therapeutic cancer vaccine composed of human recombinant EGF conjugated to a carrier protein and Montanide ISA51 as adjuvant. The vaccine is intended to induce antibodies against self EGFs that blo...

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Bibliographic Details
Published in:Clinical cancer research 2016-08, Vol.22 (15), p.3782-3790
Main Authors: Rodriguez, Pedro C, Popa, Xitllaly, Martínez, Odeth, Mendoza, Silvia, Santiesteban, Eduardo, Crespo, Tatiana, Amador, Rosa M, Fleytas, Ricardo, Acosta, Soraida C, Otero, Yanine, Romero, Gala N, de la Torre, Ana, Cala, Mireysi, Arzuaga, Lina, Vello, Loisel, Reyes, Delmairis, Futiel, Niurka, Sabates, Teresa, Catala, Mauricio, Flores, Yoanna I, Garcia, Beatriz, Viada, Carmen, Lorenzo-Luaces, Patricia, Marrero, Maria A, Alonso, Liuba, Parra, Jenelin, Aguilera, Nadia, Pomares, Yaisel, Sierra, Patricia, Rodríguez, Gryssell, Mazorra, Zaima, Lage, Agustin, Crombet, Tania, Neninger, Elia
Format: Article
Language:English
Subjects:
Adjuvants, Immunologic
Cancer Vaccines - administration & dosage
Cancer Vaccines - adverse effects
Carcinoma, Non-Small-Cell Lung - drug therapy
Carcinoma, Non-Small-Cell Lung - mortality
Carcinoma, Non-Small-Cell Lung - pathology
Epidermal Growth Factor - administration & dosage
Epidermal Growth Factor - blood
Female
Humans
Immunotherapy, Active
Kaplan-Meier Estimate
Lung Neoplasms - drug therapy
Lung Neoplasms - mortality
Lung Neoplasms - pathology
Male
Neoplasm Staging
Prognosis
Retreatment
Treatment Outcome
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Summary:EGFR is a well-validated target for patients with non-small cell lung cancer (NSCLC). CIMAvax-EGF is a therapeutic cancer vaccine composed of human recombinant EGF conjugated to a carrier protein and Montanide ISA51 as adjuvant. The vaccine is intended to induce antibodies against self EGFs that block EGF-EGFR interaction. To evaluate overall survival, safety, immunogenicity, and EGF concentration in serum after CIMAvax-EGF, a randomized phase III trial was done in patients with advanced NSCLC. Four to 6 weeks after first-line chemotherapy, 405 patients with stage IIIB/IV NSCLC were randomly assigned to a vaccine group, which received CIMAvax-EGF or a control group, treated with best supportive care. Long-term vaccination was very safe. Most frequent adverse reactions were grade 1 or 2 injection-site pain, fever, vomiting, and headache. Vaccination induced anti-EGF antibodies and decreased serum EGF concentration. In the safety population, median survival time (MST) was 10.83 months in the vaccine arm versus 8.86 months in the control arm. These differences were not significant according the standard log rank (HR, 0.82; P = 0.100), but according a weighted log rank (P = 0.04) that was applied once the nonproportionality of the HR was verified. Survival benefit was significant (HR, 0.77; P = 0.036) in the per-protocol setting (patients receiving at least four vaccine doses): MST was 12.43 months for the vaccine arm versus 9.43 months for the control arm. MST was higher (14.66 months) for vaccinated patients with high EGF concentration at baseline. Switch maintenance with CIMAvax-EGF was well tolerated and significantly increased MST of patients that completed induction vaccination. Baseline EGF concentration predicted survival benefit. Clin Cancer Res; 22(15); 3782-90. ©2016 AACR.
ISSN:1078-0432
1557-3265
DOI:10.1158/1078-0432.CCR-15-0855