ONCOmmunity

Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy

By: Brun JL, Dalstein V, Leveque J, Mathevet P, Raulic P, Baldauf JJ, Scholl S, Huynh B, Douvier S, Riethmuller D, Clavel C, Birembaut P, Calenda V, Baudin M, Bory JP.

Department of Obstetrics and Gynecology, University Hospital of Bordeaux, Laboratory of Virology, University of Bordeaux, Bordeaux, France. jean-luc.brun@chu-bordeaux.fr
Am J Obstet Gynecol. 2011 Feb; 204(2):169.e1-8.

Abstract

Objective

We sought to evaluate the safety and efficacy of TG4001 in patients with human papillomavirus (HPV) 16-related cervical intraepithelial neoplasia (CIN) 2/3 at 6 and 12 months.

Study Design

In all, 21 patients with HPV 16-related CIN 2/3 received 3 weekly subcutaneous injections of TG4001. Regression of the CIN 2/3 lesion and the clearance of HPV 16 infection were monitored by cytology, colposcopy, and HPV DNA/messenger RNA (mRNA) detection. A clinical response was defined by no CIN 2/3 found on conization, or no conization performed because not suspected at cytology or colposcopy.

Results

Ten patients (48%) were evaluated as clinical responders at month 6. Nine patients experienced an improvement of their HPV 16 infection, by mRNA ± DNA eradication. HPV 16 mRNA clearance was associated with CIN 2/3 cytologic and colposcopic regression in 7 of 10 patients. At month 12, 7 of 8 patients without conization reported neither suspicion of CIN 2/3 relapse nor HPV 16 infection. The remaining patient was lost to follow-up.

Conclusion

These promising data warrant further development of TG4001 in CIN 2/3 treatment.

PMID: 21284968 [PubMed - indexed for MEDLINE] Source: National Library of Medicine.