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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Published in:	Clinical cancer research Vol. 22; no. 15; pp. 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:	Journal Article
Language:	English
Published:	United States 01-08-2016
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.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	1078-0432 1557-3265
DOI:	10.1158/1078-0432.CCR-15-0855