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Research Oncology| Volume 204, ISSUE 2, P169.e1-169.e8, February 2011

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

DOI:https://doi.org/10.1016/j.ajog.2010.09.020
Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy
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      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.

      Key words

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      Article info

      Publication history

      Accepted: September 20, 2010
      Received in revised form: September 20, 2010
      Received: April 8, 2010

      Footnotes

      Cite this article as: Brun J-L, Dalstein V, Leveque J, et al. Regression of high-grade cervical intraepithelial neoplasia with TG4001 targeted immunotherapy. Am J Obstet Gynecol 2011;204:169.e1-8.

      The other members of the TG4001 Study Group are listed with this article.

      The first 2 authors contributed equally to this article.

      Identification

      DOI: https://doi.org/10.1016/j.ajog.2010.09.020

      Copyright

      © 2011 Mosby, Inc. Published by Elsevier Inc. All rights reserved.

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