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Afatinib With Anti-EGF Vaccine Inhibits Tumor Growth for Advanced NSCLC
The single-arm, phase 1b EPICAL trial evaluated the safety and anti-tumor activity of first line afatinib in combination with anti-epidermal growth factor (EGF) vaccination, and found it was well tolerated in patients with advanced EGFR-mutated non-small-cell lung cancer (NSCLC; Lung Cancer. 2022 Feb. epub ahea of print.)
“The combination of anti-EGFR monoclonal antibodies or immune checkpoint inhibitors with tyrosine kinase inhibitors (TKIs) has shown minimal benefit in patients with EGFR mutant NSCLC. Consequently, new combination approaches are needed,” explained Delvys Rodriguez-Abreu, MD, Universidad de Las Palmas de Gran Canaria, Spain, and co-authors.
A total of 23 patients were enrolled and 21 completed the anti-EGF immunization phase with a PFS rate of 17.5 months and an overall survival (OS) rate of 26.9 months. Treatment showed well toleration with no serious adverse events (AEs) related to the anti-EGF vaccine.
Reported objective response and disease control rates were 78.3% (95% CI, 53.6-92.5) and 95.7% (95% CI, 78.1-99.9), respectively. After a median follow-up of 24.2 months, the median progression-free survival (PFS) rate was 14.8 months (95% CI, 9.5-20.1).
At the end of the immunization phase, all patients showed high serum titers of anti-EGF antibodies, while EGF levels had decreased significantly.
“Finally, treatment with fully immunized patient’s sera inhibited the EGFR pathway in tumor cells growing in vitro. Combination treatment with an anti-EGF vaccine is well tolerated; induces a sustained immunogenic effect and might enhance the clinical efficacy of EGFR-TKIs,” concluded Dr Abreu, et al. –Alexa Stoia