Survival of NSCLC Patients Treated with Cimavax-EGF as Switch Maintenance in the Real-World Scenario

• Published in: Journal of Cancer Vol. 14; no. 5; pp. 874 - 879
• Main Authors: Flores Vega, Yoanna I, Páramo González, Diana L, Alsina Sarmiento, Sofía C, Alsina Tul, Luis E, Inguanzo Valdés, Iris B, Rodríguez Machado, Jorge, Elejalde Larrinaga, Ángel, Flores Rodríguez, Justo E, Lamadrid García, Janet, Corrales Otero, Danay, Ropero Toirac, Ramón, Crombet Ramos, Tania, Gracia Medina, Elias A
• Format: Journal Article
• Language: English
• Published: Australia Ivyspring International Publisher 01.01.2023
• Subjects: Research Paper; CIMAvax-EGF; vaccine; NSCLC; EGFR; immunotherapy
• DOI: 10.7150/jca.67189
• ISSN: 1837-9664

: In Cuba, lung cancer represents the first cause of mortality for both sexes. Non-small cell lung cancer (NSCLC) is the most prevalent histology. Overall, 75-85% of NSCLC overexpress EGFR and its ligands. EGFR overexpression has been implicated in the malignant transformation by promoting cell proliferation and survival. CIMAvax-EGF is a therapeutic vaccine composed of recombinant-human EGF conjugated to a carrier protein and Montanide as an adjuvant. CIMAvax-EGF is intended to induce antibodies against self-EGF that block the EGF-EGFR interaction. To characterize the efficacy and safety of CIMAvax-EGF as maintenance in NSCLC patients treated in the real-world setting. 106 patients diagnosed with advanced NSCLC at the National Institute of Oncology and Radiobiology, who had at least stable disease after first-line therapy, were enrolled in the study. The initial four CIMAvax-EGF doses were administered every 2 weeks and then, patients received monthly re-immunizations. Globally, 52.8% of the patients were 65 years or older, 77.4% had an ECOG 1 and 62.3% had an adenocarcinoma. The median survival time (MST) was 14.6 months. Patients younger than 65 years had a MST of 16.7 months and subjects with ECOG 0 survived for 29 months. The median progression-free survival was 8.16 months. Overall, 36.8% and 19.8% of patients maintained disease control at 6 and 12 months, respectively. The most frequent adverse events were pain (27.3%) or induration (7.3%) at the injection site and local erythema (10.9%). CIMAvax-EGF, as an EGF depleting immunotherapy used as switch-maintenance was safe and effective in patients with NSCLC.