Evidence map›Paper›PMID 40781903›Full record

Observational studyThe Laryngoscope2025

DNA Immunotherapy (INO-3107) Results in Long-Term Surgery Reduction in RRP.

Milan R Amin, Peter C Belafsky, Simon R Best, Aaron D Friedman, Adam M Klein, David G Lott, Ted Mau, Randal C Paniello, Seth M Pransky, Nabil F Saba and 6 more

Abstract readObservational Study
In one paragraph

Observational study in The Laryngoscope, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Review
  2. Article
  3. Comparison of COBioengineering (Basel, Switzerland) · 2026
    Article
  4. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Milan R AminDepartment of Otolaryngology-Head and Neck Surgery, New York University Grossman School of Medicine, New York, New York, USA.
Peter C BelafskyDepartment of Otolaryngology-Head and Neck Surgery, Davis School of Medicine, University of California, Sacramento, California, USA.
Simon R BestDepartment of Otolaryngology-Head and Neck Surgery, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.ORCID 0000-0001-8699-033X
Aaron D FriedmanDivision of Laryngology, Department of Otolaryngology-Head and Neck Surgery, University of Cincinnati Medical Center, Cincinnati, Ohio, USA.
Adam M KleinDepartment of Otolaryngology-Head and Neck Surgery, Emory University School of Medicine, Atlanta, Georgia, USA.
David G LottDivision of Laryngology, Mayo Clinic Arizona, Phoenix, Arizona, USA.ORCID 0000-0001-6541-9687
Ted MauDepartment of Otolaryngology-Head and Neck Surgery, Voice Center, University of Texas Southwestern Medical Center, Dallas, Texas, USA.ORCID 0000-0002-1804-6707
Randal C PanielloDepartment of Otolaryngology-Head and Neck Surgery, Washington University School of Medicine, St. Louis, Missouri, USA.ORCID 0000-0002-0631-0144
Seth M PranskyPediatric Specialty Partners of San Diego, San Diego, California, USA.
Nabil F SabaDepartment of Hematology and Medical Oncology, the Winship Cancer Institute, Emory University, Atlanta, Georgia, USA.
Christopher WelshInovio Pharmaceuticals, Plymouth Meeting, Pennsylvania, USA.
Stefani A SlogInovio Pharmaceuticals, Plymouth Meeting, Pennsylvania, USA.ORCID 0009-0006-5528-9034
Elisabeth GillespieInovio Pharmaceuticals, Plymouth Meeting, Pennsylvania, USA.
Michael DallasInovio Pharmaceuticals, Plymouth Meeting, Pennsylvania, USA.
Matthew P MorrowInovio Pharmaceuticals, Plymouth Meeting, Pennsylvania, USA.
Jeffrey M SkolnikInovio Pharmaceuticals, Plymouth Meeting, Pennsylvania, USA.

Funding

INOVIO Pharmaceuticals
6 · The paper itself

Abstract

objectiveTo evaluate the long-term safety and clinical effect of INO-3107 immunotherapy in adults with recurrent respiratory papillomatosis (RRP).

methodsRRP-002 was a retrospective, observational extension study that followed patients enrolled in the 52-week RRP-001 study. Patients with moderate to severe juvenile or adult-onset RRP who had undergone ≥ 2 surgical interventions in the year preceding dosing were eligible for enrollment in RRP-001. Participants underwent surgical debulking within 14 days prior to initial dosing and then received INO-3107 on Day 0, Weeks 3, 6, and 9. Efficacy assessments during RRP-002 follow-up were the frequency of surgical interventions and alternative medication use. The safety evaluation included reported serious adverse events (SAEs).

resultsTwenty-eight (28) of 32 participants from the 52-week RRP-001 study were enrolled in RRP-002. The median follow-up time for RRP-002 was 1.8 years (range: 1.2-2.4 years) for a total median assessment time of 2.8 years (range: 1.0-3.5 years). There were no SAEs or long-term safety concerns identified. The mean number of surgeries was reduced from 4.1 in the pre-treatment period to 1.7 in the first year post-INO-3107 treatment (Year 1) to 0.9 in the second year (Year 2). The complete response rate (0 surgeries per year) increased from 28% (9/32) in Year 1 to 50% (14/28) in Year 2.

conclusionINO-3107 is well tolerated and provides a continued clinical effect against HPV-6 and 11 RRP that results in further reduction of the surgical burden observed in Year 1. These data support the role of INO-3107 immunotherapy for adult patients with RRP. LEVEL OF EVIDENCE: III.

Indexed as

ImmunotherapyPapillomavirus InfectionsRespiratory Tract InfectionsVaccines, DNAAdolescentAdultAgedCytoreduction Surgical ProceduresFemaleFollow-Up StudiesHumansMaleMiddle AgedRetrospective StudiesTreatment OutcomeYoung AdultVaccines, DNADNA immunotherapyHPV‐11HPV‐6recurrent respiratory papillomatosisreduced surgeries

Identifiers

PMID40781903
PMCPMC12645365

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.