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Padeliporfin

Padeliporfin, also known as WST11, is a drug currently being studied in clinical trials for the treatment of Upper Tract Urothelial Cancer (UTUC). This article explores the ongoing research on padeliporfin and its potential benefits for patients with low-grade non-invasive UTUC in either the kidney or ureter.

Table of Contents

What is Padeliporfin?

Padeliporfin, also known by its other name WST11, is a new drug being studied for the treatment of certain types of cancer[1]. It’s currently undergoing clinical trials to evaluate its safety and effectiveness in treating Upper Tract Urothelial Cancer (UTUC), a type of cancer that affects the lining of the urinary system in the upper part of the body, specifically in the kidney and ureter.

How Does Padeliporfin Work?

Padeliporfin is used in a treatment called Vascular Targeted Photodynamic Therapy (VTP). This innovative approach combines the drug with light activation to target and destroy cancer cells. Here’s how it works[1]:

  1. The drug is administered intravenously (through a vein) at a dose of 3.66 mg/kg over 10 minutes.
  2. A special optical light fiber is placed near the tumor using a medical instrument called a ureteroscope.
  3. The target area is then illuminated with light for 10 minutes, activating the drug and destroying the cancer cells.

What Conditions Does Padeliporfin Treat?

Padeliporfin is being studied specifically for the treatment of Transitional Cell Cancer of Renal Pelvis and Ureter[1]. This is a type of cancer that develops in the cells lining the renal pelvis (part of the kidney) and the ureter (the tube connecting the kidney to the bladder). The current study focuses on patients with low-grade, non-invasive upper tract urothelial carcinoma, which means the cancer is in its early stages and hasn’t spread deeply into the surrounding tissues.

The ENLIGHTED Study

The main clinical trial investigating Padeliporfin is called the ENLIGHTED study (ENdoluminal LIGHT ActivatED Treatment of Upper Tract Urothelial Cancer)[1]. This is a Phase 3 study, which means it’s in an advanced stage of clinical research. The study is designed to evaluate how safe and effective Padeliporfin VTP is in treating low-grade UTUC.

Treatment Phases

The ENLIGHTED study consists of three main phases[1]:

  1. Induction Treatment Phase: Patients receive 1-3 Padeliporfin VTP treatments, each 4 weeks apart. The goal is to achieve a Complete Response (CR), which means no visible tumor, negative urine tests for cancer cells, and no evidence of tumor on biopsy.
  2. Maintenance Treatment Phase: If CR is achieved, patients enter this 12-month phase. They receive additional VTP treatments if there’s evidence of tumor recurrence that meets certain criteria.
  3. Long-Term Follow-up Phase: Patients who complete the maintenance phase are followed for up to an additional 48 months to monitor for any cancer recurrence or treatment-related side effects.

Expected Outcomes

The ENLIGHTED study aims to measure several important outcomes[1]:

  • The number of patients who achieve complete absence of UTUC tumors after treatment
  • How long patients remain cancer-free after treatment
  • The effect of the treatment on overall kidney function
  • Whether the treatment helps preserve the kidney, avoiding the need for its surgical removal
  • How the treatment affects patients who have blockages in their ureters

Safety and Long-Term Follow-up

The study includes extensive follow-up to ensure the safety of the treatment[1]. Patients will be monitored for up to 5 years after treatment to check for any long-term effects, including:

  • Continued absence of cancer
  • Preservation of the kidney
  • Overall kidney function
  • Any adverse events or side effects related to the treatment

Additionally, the study will collect blood, tumor, and urine samples for genomic sequencing. This will help researchers understand how genetic factors might influence treatment response and cancer progression[1].

Aspect Details
Drug Name Padeliporfin (WST11)
Treatment Type Vascular Targeted Photodynamic Therapy (VTP)
Target Condition Low-grade non-invasive Upper Tract Urothelial Carcinoma (UTUC)
Treatment Phases Induction, Maintenance, Long Term Follow-up
Primary Outcome Measure Absence of UTUC tumors in treated area
Secondary Outcomes Duration of response, renal function, kidney preservation
Administration Method Intravenous infusion + light activation via ureteroscope
Treatment Duration 10-minute illumination per target area
Follow-up Period Up to 5 years post-treatment

FAQ

  • What is Padeliporfin and how does it work? Padeliporfin is a drug used in Vascular Targeted Photodynamic Therapy (VTP) for treating Upper Tract Urothelial Cancer. It is administered intravenously and activated by light, targeting cancer cells in the urinary tract.
  • What type of cancer is being treated in this clinical trial? The clinical trial is focusing on low-grade non-invasive Upper Tract Urothelial Carcinoma (UTUC), which affects the lining of the kidney or ureter.
  • How is the treatment administered? The treatment involves intravenous administration of padeliporfin, followed by illumination of the target area using an optical light fiber inserted through a ureteroscope. Each treatment session lasts about 10 minutes.
  • What are the phases of treatment in this clinical trial? The trial consists of three phases: an Induction Treatment Phase (1-3 treatments), a Maintenance Treatment Phase (up to 12 months), and a Long Term Follow-up Phase (up to 48 additional months).
  • How is the effectiveness of the treatment measured? The primary measure of effectiveness is the absence of UTUC tumors in the treated area, as determined by endoscopic evaluation, biopsy (if feasible), and negative urinary cytology.

Ongoing Clinical Trials on Padeliporfin

  • Study on the Safety and Effectiveness of Padeliporfin Therapy for Patients with Low-Grade Upper Tract Urothelial Cancer

    Recruiting

    1 1 1 1
    Investigated drugs:
    Austria France Germany Italy Spain

Glossary

  • Upper Tract Urothelial Carcinoma (UTUC): A type of cancer that occurs in the lining of the kidney or ureter.
  • Vascular Targeted Photodynamic Therapy (VTP): A treatment that uses a light-sensitive drug and a specific type of light to target and destroy cancer cells.
  • Padeliporfin: The drug being studied in this clinical trial, also known as WST11, used in VTP for treating UTUC.
  • Ureteroscope: A thin, flexible tube with a camera used to examine and treat problems in the urinary tract.
  • Complete Response (CR): The absence of visible tumor on endoscopy, negative urinary cytology, and no evidence of tumor on biopsy (if feasible).
  • Induction Treatment Phase: The initial phase of treatment consisting of 1-3 padeliporfin VTP treatments provided 4 weeks apart.
  • Maintenance Treatment Phase: A 12-month period following the Induction Phase, during which patients are monitored and may receive additional treatments if needed.
  • Long Term Follow-up Phase: An additional monitoring period of up to 48 months after the Maintenance Phase to assess long-term outcomes and safety.
  • Cytology: The examination of cells under a microscope, often used to detect cancer.
  • Glomerular Filtration Rate (eGFR): A measure of kidney function, calculated from blood creatinine levels.
  • Nephroureterectomy: Surgical removal of the kidney and ureter.
  • Ureterectomy: Surgical removal of the ureter.

References