Objective:

The article examines the objective, findings, and clinical context described in FDA approves HPV immunotherapy for RRP.

Approach:

• Approval: The FDA granted accelerated approval to INOVIO’s Voceryq to reduce the frequency of surgical papilloma excisions in adults with RRP.
• Treatment: Voceryq contains DNA plasmids encoding HPV-6 and HPV-11 antigens and interleukin-12. It is administered intramuscularly with the CELLECTRA 5PSP device.
• Evidence: Approval was supported by a multicenter, open-label, single-arm phase 1/2 study of 32 adults who had required at least two surgical interventions in the prior 12 months.

Key Findings:

• Among 26 participants who had required at least three surgeries before treatment, 7 had no surgical papilloma excisions during the following 12 months.
• The median number of surgeries before treatment in this efficacy population was 4.5.
• Most treatment-related adverse reactions were mild or moderate; commonly reported reactions included injection-site reactions, headache, fatigue, hypertension, nausea, and dizziness.

Interpretation:

The study assessed safety and tolerability as its primary end point and surgical frequency as a secondary end point. Its lack of a concurrent control group limits conclusions about comparative efficacy.

Limitations:

• The supporting study was open-label and single-arm, with no concurrent control group.
• Continued approval may depend on verification of clinical benefit in a confirmatory study.

Conclusion:

The FDA prescribing information recommends four 6.25-mg doses given three weeks apart, after surgical removal of visible papillomas. A trained health care professional must administer treatment using the CELLECTRA device.

Sources:

• FDA press release
• FDA prescribing information
• INOVIO press release