In a Phase 3 clinical trial, researchers evaluated I/ONTAK (also known as E7777) as a potential therapeutic option for persistent or recurrent cutaneous T-cell lymphoma (CTCL). According to Targeted Oncology, 112 adult patients with CD25 assay-positive CTCL enrolled within this trial; findings from the study highlight the drug’s safety, efficacy, and tolerability.
What is I/ONTAK?
Within this clinical trial, researchers sought to understand the potential benefits of I/ONTAK. Drug developer Citius Pharmaceuticals describes I/ONTAK as an intravenously administered engineered IL-2-diphtheria toxin fusion protein and:
purified reformulation of denileukin difitox (ONTAK), a previously FDA-approved cancer immunotherapy. Improvements to the original formulation resulted in a therapy that maintains the same amino acid sequence, but features greater purity and bioactivity.
In the first portion of the trial, researchers sought to determine the ideal recommended dose of I/ONTAK. Eventually, researchers determined that the recommended treatment dose was 9 μg/kg/day. Next, in the second part of the study, researchers analyzed how CTCL responded to this treatment. Findings included:
- In patients assessed for efficacy, the trial saw an overall response rate of 36.2% for primary efficacy, with 42.3% for total overall efficacy (including the trial lead-in).
- Altogether, I/ONTAK was relatively safe and well-tolerated. Adverse reactions included nausea, swelling of the hands and lower legs, fatigue, and chills. However, I/ONTAK was largely able to kill cancerous cells without additional toxicity in the body.
- The average time it took for patients to respond to treatment was 1-2 days.
About Cutaneous T-Cell Lymphoma (CTCL)
There are multiple different forms of cutaneous T-cell lymphoma (CTCL), a group of disorders existing under the larger umbrella of non-Hodgkin’s lymphoma. However, each condition is characterized by malignant T-cells collecting abnormally in the skin, causing rashes, tumors, plaques, or similar manifestations. Mycosis fungoides, Sézary Syndrome, lymphomatoid papulosis, and Woringer-Kolopp disease are all subtypes of CTCL. Doctors are not exactly sure what causes CTCLs. However, risk factors include being older in age, being male, having an Epstein-Barr virus (EBV) infection, or being immunocompromised.
In many cases, patients with CTCL only experience skin-related symptoms. However, up to 10% of patients whose condition recurs or progresses may develop serious complications. Symptoms vary based on CTCL subtype. So if you or someone you know has recently been diagnosed with CTCL, please look up the specific subtype for more targeted information on the condition, symptoms, and treatment options. For now, some symptoms of CTCL may include:
- Alopecia (hair loss)
- Swollen lymph nodes
- Nonspecific dermatitis appearing in patches
- Intensely itchy skin plaques
- Tumors, which are prone to ulceration
- Patches of skin which may appear to be lighter in color than surrounding skin
- Thickened skin on the palms and soles
- Edematous skin (swelling beneath the skin which causes redness, or stretched and shiny skin)
- Enlarged liver and spleen
- Nail dystrophy
