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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
  1. Chel Hun Choi1,
  2. Jeong-Won Lee2,
  3. Eun-Suk Kang2,
  4. Duck Cho2,
  5. Yong-Man Kim2,
  6. Kidong Kim3,
  7. Jae-Weon Kim4,
  8. Hee Seung Kim5,
  9. Young Tae Kim2,
  10. Jung-Yun Lee3,
  11. Myong Cheol Lim4,
  12. Chang Yuil Kang6 and
  13. Byoung Gie Kim7
  1. 1Samsung Medical Center, Department of Obstetrics and Gynecology, Seoul, Korea, Republic of
  2. 2Research Institute for Future Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea, Republic of
  3. 3Seoul National University Bundang Hospital, Department of Obstetrics and Gynecology, Seongnam, Korea, Republic of
  4. 4Seoul National University Hospital, Clinical Trial Center, Seoul, Korea, Republic of
  5. 5Konkuk University Hospital, Obstetrics and Gynecology, Seoul, Korea, Republic of
  6. 6Cellid, Phamacology, Seoul, Korea, Republic of
  7. 7Samsung Medical Center, Sungkyunkwan University School of Medicine, Obgyn, Seoul, Korea, Republic of


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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