AHFS Class:

• Gene Therapy 26:12

Brands:

• Papzimeos^®

Generic Name(s):

• Zopapogene Imadenovec-drba

Zopapogene imadenovec-drba is a non-replicating adenoviral vector-based immunotherapy.1

Zopapogene imadenovec-drba has the following uses:

Zopapogene imadenovec-drba is indicated for the treatment of adults with recurrent respiratory papillomatosis and has been designated an orphan drug by FDA for this use.1,  2

Efficacy of zopapogene imadenovec-drba was evaluated in an open-label, ongoing single-arm trial (PRGN-2012-201) in adults with histological and clinically diagnosed recurrent respiratory papillomatosis who had 3 or more debulking procedures to remove laryngotracheal papillomas in the prior 12 months.1 A total of 35 patients were included in the efficacy population; these patients received subcutaneous injections of zopapogene imadenovec-drba (5 x 10¹¹ particle units [PU]) on days 1, 15, 43, and 85.1 Complete response (defined as no requirement for surgical intervention in the 12 months after treatment) was achieved in 51% of patients; 15 out of the 18 patients who had a complete response continued to benefit from the drug at 2 years (complete response rate at 24 months was 43%).1

General

Zopapogene imadenovec-drba is available in the following dosage form(s) and strength(s):

Single-dose vial that contains 5×10¹¹ particle units (PU) in an extractable volume of 1 mL of suspension.1

Dosage

It is essential that the manufacturer's labeling be consulted for more detailed information on dosage and administration of this drug. Dosage summary:

Adults

Dosage and Administration

Zopapogene imadenovec-drba is for subcutaneous injection only.1

The recommended dose of zopapogene imadenovec-drba is 5×10¹¹ particle units (PU) per injection administered by subcutaneous injection 4 times over a 12-week interval.1 The second dose should be administered 2 weeks (no less than 11 days) after initial administration.1 The third dose should be administered 6 weeks after initial administration, and the fourth dose should be administered 12 weeks after initial administration.1

Prior to the initial administration of zopapogene imadenovec-drba, perform a surgical debulking of visible papilloma to establish minimal residual disease.1 To maintain minimal residual disease during treatment with zopapogene imadenovec-drba, remove visible papilloma, if present, prior to the third and fourth administration of zopapogene imadenovec-drba.1

Zopapogene imadenovec-drba is a non-replicating adenoviral vector-based immunotherapy.1 Follow universal biosafety precautions for handling.1

Zopapogene imadenovec-drba is provided as a single-dose vial of sterile frozen suspension that MUST BE RAPIDLY thawed before use and prepared for immediate administration.1 See Full Prescribing Information for additional preparation, handling, and administration instructions.1

Contraindications

None.1

Warnings/Precautions

Injection-site Reactions

Injection-site reactions have occurred with zopapogene imadenovec-drba injection.1 Monitor patients for local site reactions for at least 30 minutes after the initial treatment and manage accordingly. 1

Thrombotic Events

Thrombotic events may occur following administration of adenoviral vector-based therapies including zopapogene imadenovec-drba due to the potential to induce prothrombotic antibody development.1 Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice. 1

Specific Populations

Pregnancy

There are no available data with zopapogene imadenovec-drba in pregnant women.1 Animal reproductive and developmental toxicity studies have not been conducted with zopapogene imadenovec-drba.1 In the PRGN-2012-201 study, one patient reported pregnancy at 6 months following completion of treatment with zopapogene imadenovec-drba.1 The patient delivered at 40 weeks without any reported birth complications or neonatal concerns. 1

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. 1

Lactation

There is no information available on the presence of zopapogene imadenovec-drba in human milk, the effects on the breastfed infant, or the effects on milk production.1 The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for zopapogene imadenovec-drba and any potential adverse effects on the breastfed child from zopapogene imadenovec-drba or from the underlying maternal condition. 1

Pediatric Use

The safety and effectiveness of zopapogene imadenovec-drba have not been established in pediatric patients. 1

Geriatric Use

There were 9 patients (24%) 65 years of age and older and 1 patient (3%) 75 years of age and older in Study PRGN-2012-201.1 Clinical studies of zopapogene imadenovec-drba did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger patients. 1

Common Adverse Effects

The most common adverse reactions (incidence ≥5%) were injection site reactions, fatigue, chills, pyrexia, myalgia, nausea, headache, tachycardia, diarrhea, vomiting, and hyperhidrosis.1

Specific Drugs

It is essential that the manufacturer's labeling be consulted for more detailed information on interactions with this drug, including possible dosage adjustments. Interaction highlights:

Please see product labeling for drug interaction information.

Actions

Mechanism of Action

Zopapogene imadenovec-drba is a non-replicating adenoviral vector-based immunotherapy designed to express a fusion antigen of selected regions of human papillomavirus (HPV) proteins expressed in HPV 6- and HPV 11-infected cells.1 Zopapogene imadenovec-drba is designed to generate an immune response directed against HPV 6 and HPV 11 proteins in patients with recurrent respiratory papillomatosis. 1

Advice to Patients

• Inform patients that injection site reactions have occurred after zopapogene imadenovec-drba injection.1 Signs and symptoms may include reactions such as redness, pain, swelling, itching, or warmth at the injection site.1 Advise patients to manage symptoms with cold compresses, over the counter pain relievers or antihistamines, if needed.1 Seek medical care if symptoms worsen or are accompanied by signs of a systemic allergic reaction (difficulty breathing, widespread rash, facial swelling) or infection. 1
• Inform patients that thrombotic events may occur after zopapogene imadenovec-drba injection.1 Signs and symptoms may include shortness of breath, chest pain, leg swelling, persistent abdominal pain, or neurological symptoms (including severe or persistent headaches or blurred vision).1 Monitor patients for signs and symptoms of thrombotic events and treat events according to clinical practice. 1

Additional Information

AHFS first Release^™. For additional information until a more detailed monograph is developed and published, the manufacturer's labeling should be consulted. It is essential that the manufacturer's labeling be consulted for more detailed information on usual uses, dosage and administration, cautions, precautions, contraindications, potential drug interactions, laboratory test interferences, and acute toxicity.

1. Precigen, Inc.. PAPZIMEOS^® (zopapogene imadenovec) SUBCUTANEOUS prescribing information. 2025 Aug. [Web]

2. Food and Drug Administration. Orphan designations pursuant to Section 526 of the Federal Food and Cosmetic Act as amended by the Orphan Drug Act (P.L. 97-414). Rockville, MD; from FDA website