- 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.
- 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.
- 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>
- Study was underpowered for a specific efficacy.