Introduction BVAC-C, a B cell- and monocyte-based immunotherapeutic vaccine transfected with recombinant HPV E6/E7, has been shown to be well tolerated in HPV positive recurrent cervical carcinoma in a phase I study. This phase IIa study aimed to determine the antitumor activity of BVAC-C in patients with HPV 16 or 18 positive recurrent cervical cancer who had experienced recurrence after one prior platinum-based combination chemotherapy.
Methods Primary endpoints were safety and objective response rate (ORR) assessed by independent radiologist per RECIST version 1.1. Secondary endpoint included Disease control rate (DCR), progression-free survival (PFS), and overall survival (OS).
Results Of the 30 patients available for analysis, the objective response rate (ORR) was 19.2%, the disease control rate (DCR) was 53.8%, and the median progression-free survival (PFS) was 5.8 months. Median overall survival (OS) was 17.7 months. Immune responses of patients after vaccination were shown to be correlated with clinical responses of them.
Conclusion/Implications BVAC-C represents a promising treatment option in the second-line setting for this patient population, with a manageable safety profile. Further studies are needed to identify potential biomarkers of response.
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