PT  - JOURNAL ARTICLE
AU  - Choi, Chel Hun
AU  - Lee, Jeong-Won
AU  - Kang, Eun-Suk
AU  - Cho, Duck
AU  - Kim, Yong-Man
AU  - Kim, Kidong
AU  - Kim, Jae-Weon
AU  - Kim, Hee Seung
AU  - Kim, Young Tae
AU  - Lee, Jung-Yun
AU  - Lim, Myong Cheol
AU  - Kang, Chang Yuil
AU  - Kim, Byoung Gie
TI  - PR008/#805  Efficacy and safety of BVAC-C in HPV type 16 or 18 positive cervical carcinoma who failed 1st platinum based chemotherapy: a phase I/IIA study
AID  - 10.1136/ijgc-2023-IGCS.51
DP  - 2023 Nov 01
TA  - International Journal of Gynecologic Cancer
PG  - A35--A35
VI  - 33
IP  - Suppl 4
4099  - http://ijgc.bmj.com/content/33/Suppl_4/A35.1.short
4100  - http://ijgc.bmj.com/content/33/Suppl_4/A35.1.full
SO  - Int J Gynecol Cancer2023 Nov 01; 33
AB  - 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.