Therapeutic vaccine targets HPV, clears cervical cancer precursors

  • Harper DM & al.
  • Gynecol Oncol
  • 2 Apr 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • In women with cervical intraepithelial neoplasia grades 2/3 (CIN 2/3) associated with single or multiple high-risk HPV infections, therapeutic vaccine tipapkinogen sovacivec (TS) showed greater complete resolution of lesions vs placebo, irrespective of viral subtype.
  • The vaccine also reduces HPV viral load and is safe through 2.5 years.

Why this matters

  • Encouraging results call for evaluation in other HPV-related cancers.

Study design

  • Randomized, double-blind, placebo-controlled phase 2b trial of 129 women (age, ≥18 years) with confirmed CIN2/3 associated with single or multiple HR HPV infections, randomly assigned to receive TS vaccine or placebo.
  • 13 high-risk HPV types assayed. 
  • Funding: F. Hoffmann-La Roche LTD.

Key results

  • At 6 months, complete resolution was significantly higher in the vaccine group than placebo, regardless of high-risk HPV type in patients with:
    • CIN 2/3 (24% vs 10%; P<.05>
    • only CIN 3 (21% vs 0%; P<.01>
  • At 2.5 years, viral DNA clearance of all CIN2/3 regardless of high-risk HPV type was significantly higher in the vaccine group (P<.01>
  • The vaccine was well tolerated, with the most common adverse events being injection site reactions (severe grade, 29%).

Limitations

  • Study was underpowered for a specific efficacy.

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