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Gynecol Oncol. 2019 Jun;153(3):521-529. doi: 10.1016/j.ygyno.2019.03.250. Epub 2019 Apr 4.

The efficacy and safety of Tipapkinogen Sovacivec therapeutic HPV vaccine in cervical intraepithelial neoplasia grades 2 and 3: Randomized controlled phase II trial with 2.5 years of follow-up.

Author information

1
Department of Family and Community Medicine, Obstetrics and Gynecology, University of Missouri Kansas City, 7900 Lee's Summit Road, Kansas City, MO 64139, USA. Electronic address: harperdi@med.umich.edu.
2
Department of Obstetrics and Gynaecology, Helsinki University Hospital and Helsinki University, Box 615, 00029 HUS, Helsinki, Finland. Electronic address: pekka.nieminen@hus.fi.
3
Department of Obstetrics and Gynaecology, University Hospital Antwerp, Wilrijksesteenweg 10, 2000 Antwerp-Ekeren, Belgium. Electronic address: Gilbert.Donders@uza.be.
4
Department of Obstetrics and Gynecology, Albert Einstein Cancer Center and Montefiore Medical Center, 111 East 210th Street, Bronx, NY 10467, USA. Electronic address: me399@njms.rutgers.edu.
5
Center of Excellence in Women's Health at the University of Arizona, 1501 N Campbell Ave, Tucson, AZ 85714, USA. Electronic address: Francisco.Garcia@pima.gov.
6
Department of Obstetrics and Gynecology, University of Alabama, 1700 6th Avenue South, WIC Room 10250, Birmingham, AL 35233, USA. Electronic address: whuh@uabmc.edu.
7
Surgical Pathology, P.O. Box 800214, Department of Pathology, University of Virginia Health System, University of Virginia, Charlottesville, VA, USA. Electronic address: mhs2e@me.comall.
8
Roche Pharmaceutical Research & Early Development, Roche Innovation Center Basel, F. Hoffmann-La Roche Ltd. Building 93, Room 7.38.01, Grenzacherstrasse 124, Basel 4070, Switzerland. Electronic address: katerina.glavini@roche.com.
9
Roche Pharmaceutical Research & Early Development, Roche Innovation Center New York, 430 E. 29th Street New York City, New York 10016, USA. Electronic address: gemma.attley.ga1@roche.com.
10
Department of Medical Affairs, Transgene SA, 400 Bb Gonthier d'Andernach Parc d'innovation, CS80166, 67405 Illkirch-Graffenstaden Cedex, France. Electronic address: jean-marc.limacher@ch-colmar.fr.
11
Department of Biostatistics, Transgene S.A., Boulevard Gonthier d'Andernach Parc d'innovation, CS80166, 67405 Illkirch-Graffenstaden Cedex, France. Electronic address: bastien@transgene.fr.
12
Roche Pharmaceutical Research & Early Development, Roche Innovation Center New York, 430 E. 29th Street New York City, New York 10016, USA. Electronic address: elizabethcalleja@netscape.net.

Abstract

BACKGROUND:

While prophylactic human papillomavirus (HPV) vaccination exists, women are still developing cervical intraepithelial neoplasia (CIN) grade 2 or 3 for which an immunotherapeutic, non-surgical, approach may be effective. The primary aim was to assess the efficacy of tipapkinogen sovacivec (TS) vaccine in achieving histologic resolution of CIN2/3 associated with high risk (HR) HPV types.

METHODS:

Women 18 years and older who had confirmed CIN2/3 were enrolled in a randomized, double blind, placebo-controlled phase II trial and assigned to drug in a 2:1 ratio (vaccine:placebo). The primary endpoint occurred at month 6 when the excisional therapy was performed; cytology and HR HPV typing were performed at months 3, 6 and every six months through month 30. The safety population included all patients who received at least one dose of study drug.

RESULTS:

Of the 129 women randomized to vaccine and 63 to placebo, complete resolution was significantly higher in the vaccine group than placebo for CIN 2/3 regardless of the 13 HR HPV types assayed (24% vs. 10%, p < 0.05); as well as for only CIN 3 also regardless of HR HPV type (21% vs. 0%, p < 0.01). Irrespective of baseline HPV infection, viral DNA clearance was higher in the vaccine group compared to placebo (p < 0.01). The vaccine was well tolerated with the most common adverse events being injection site reactions.

CONCLUSIONS:

The TS vaccine provides histologic clearance of CIN 2/3 irrespective of HR HPV type in one third of subjects and is generally safe through 30 months.

KEYWORDS:

CIN 2/3; Cervical cancer; HPV; Immunotherapy; Therapeutic vaccine; Women

PMID:
30955915
DOI:
10.1016/j.ygyno.2019.03.250
[Indexed for MEDLINE]
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