Early Study Shows Potential Use of Investigational Drug in Patients With Kidney, Lung Cancer

An investigational medication combined with immunotherapy agents has shown promise for certain patients with kidney and lung cancer in an early phase trial, according to study findings published in the Lancet Oncology.

Pegilodecakin, which is currently being examined in clinical trials, works by stimulating the survival, proliferation and “killing” potential CD8+ T cells which can recognize and destroy cancer cells. When combined with anti-PD1 monoclonal antibodies, such as Opdivo (nivolumab) and Keytruda (pembrolizumab), pegilodecakin complements the therapies, the researchers said.

“Pegilodecakin with anti-PD-1 monoclonal antibodies had a manageable toxicity profile and promising anti-tumor activity,” Dr. Aung Naing, associate professor of investigational cancer therapeutics at The University of Texas MD Anderson in Houston, said in a press release.

In the phase 1b trial, researchers looked at 111 patients between February 2015 and September 2017 across a dozen cancer centers in the United States. Patients had five different solid tumor types: renal cell carcinoma (34%), melanoma (33%), non-small cell lung cancer (31%), triple-negative breast cancer (less than 1%) and bladder cancer (less than 1%). All were either fully active or slightly restricted on strenuous activity.

Patients were separated into two groups — 53 received pegilodecakin plus Keytruda and 58 received pegilodecakin plus Opdivo. Researchers examined the medication in patients for safety, tolerability and maximal tolerated dose.

They found that tumors shrunk in 43% of patients with non-small cell lung cancer and 40% of patients with kidney cancer. In the patients with melanoma, only 10% saw a reduction.

“Our study showed this combination demonstrated favorable response in non-small cell lung cancer and kidney cancer patients who previously had been treated when compared to those treated with anti-PD-1 monoclonal antibodies alone,” Naing said.

At least one treatment-related side effect occurred in 93% of patients. Severe or serious side effects were seen in 66% of patients (35 patients in the Keytruda group and 38 patients in the Opvido group). The most common included anemia, fatigue, low blood platelet counts and high triglycerides, which are a type of fat found in the blood that store unused calories and provide the body with energy.

“The activity of pegilodecakin in combination with anti-PD-1 monoclonal antibodies introduces a new class of drugs to the treatment of advanced solid tumors,” Naing said. “Future randomized trials hopefully will determine the tolerability and clinical benefits of pegilodecakin as a single agent and in combinations in a range of cancers.”