A New Drug Shows Promising Results in the Treatment of Lung and Kidney Cancer

The first of its kind drug for the treatment of oncological diseases, pegilodecakin, has shown positive results regarding safety and the potential to become a new therapeutic option for patients with non-small cell lung cancer and kidney cancer.

A multicenter study demonstrated that the experimental drug in combination with two well-known antitumor drugs, which are monoclonal antibodies inhibiting the membrane protein PD-1 – pembrolizumab and nivolumab – achieved clinically significant results in patients with non-small cell lung cancer and kidney cancer. Its main findings were presented in the prestigious medical journal The Lancet Oncology.

"As the trials showed, the use of pegilodecakin together with anti-PD-1 monoclonal antibodies has a manageable toxicity profile and promising antitumor activity," says Dr. Aung Naing from the Department of Cancer Research and Treatment at the Oncology Center. "Our study demonstrated that the proposed combination has a positive effect in patients with non-small cell lung cancer and kidney cancer, unlike those who received only anti-PD-1 monoclonal antibodies."

The study was designed to evaluate the safety, tolerability, and determine the maximum tolerated dose of pegilodecakin in combination with pembrolizumab or nivolumab, as well as to study biomarkers to identify patients who may potentially respond to treatment. It was conducted from February 2015 to September 2017 with the participation of 111 individuals diagnosed with kidney cancer, non-small cell lung cancer, and melanoma (skin cancer) at an advanced stage.

The most common side effects of the experimental therapy were anemia, fatigue, low platelet count, and high triglyceride levels.

An objective response to treatment was observed in 43% of patients with lung tumours, 40% of patients with kidney cancer, and 10% with melanoma. All participants received treatment until the disease began to progress, or signs of toxicity appeared, or the patient wished to withdraw from the study. At the same time, patients continued to receive combination therapy or only pegilodecakin after disease progression if the researchers were confident in the appropriateness of the treatment.

Pegilodecakin consists of recombinant interleukin 10 (IL-10) linked to a molecule called polyethylene glycol. The IL-10 protein is a natural immune growth factor that regulates the activity of various immune cells – high concentrations of it activate the immune response against cancer cells. The attachment of the polyethylene glycol molecule to this protein increases its size, which prevents or slows its degradation, thereby prolonging its circulation time in the body.

The drug stimulates the survival, proliferation, and cytotoxic potential of CD8+ T lymphocytes, which are responsible for recognizing and destroying malignant cells. It is believed that increasing the content of this type of immune cell in the tumour improves the prognosis and survival of the patient. The immunostimulatory action of pegilodecakin complements the action of anti-PD-1 monoclonal antibodies, which block the protective mechanism of cancer cells that inhibits T-cell activity.

"The effectiveness of pegilodecakin in combination with anti-PD-1 monoclonal antibodies suggests a new class of drugs for the treatment of common solid tumours," notes Dr. Naing. "Future studies, we hope, will determine the tolerability and clinical benefits of pegilodecakin – both as monotherapy and in combination – in the treatment of a range of oncological diseases."