New clinical data shows that Eli Lilly’s investigational oncology drug pegilodecakin, in combination with a checkpoint inhibitor, could be a potential new treatment for patients with non-small cell lung cancer and kidney cancer.
New clinical data shows that Eli Lilly’s investigational oncology drug pegilodecakin, in combination with a checkpoint inhibitor, could be a potential new treatment for patients with non-small cell lung cancer and kidney cancer.
A Phase Ib study led by MD Anderson Cancer Center showed that combining pegilodecakin, a PEGylated IL-10 (Interleukin-10), with two leading anti-PD-1 drugs, Merck’s Keytruda and Bristol-Myers Squibb’s Opdivo, achieved measurable responses for patients with these types of cancers, as well as melanomas. Pegilodecakin is designed to activate tumor-reactive cytotoxic CD8+ T cells in patients. CD8+ T cells mediate the tumor clearing effect of this immuno-oncology agent. The early-stage study was designed to assess the safety of the combination treatment, as well as tolerability and maximally tolerated dose, the cancer center announced this morning. The study, which included 111 patients, also looked at biomarkers to identify patients likely to respond to treatment. Data from the study was published Thursday in an online issue of The Lancet Oncology.
Aung Naing, associated professor of investigational cancer therapeutics at MD Anderson, said pegilodecakin combined with anti-PD-1 monoclonal antibodies had a manageable toxicity profile and showed promising anti-tumor activity. Objective responses were seen in 43% of NSCLC patients, 40% of kidney cancer patients and 10% of melanoma patients. Patients received pegilodecakin with Keytruda or Opdivo until the disease worsened or there were toxicity concerns necessitating discontinuation of treatment.
“Our study showed this combination demonstrated favorable response in NSCLC and kidney cancer patients who previously had been treated when compared to those treated with anti-PD-1 monoclonal antibodies alone,” Naing said in a statement.
Patients continued to receive combination therapy or pegilodecakin alone after disease progression if the investigator determined that the patient would continue to benefit. The most common side effects were anemia, fatigue, low blood platelet counts and high triglycerides.
“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 added in a statement. “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.”
MD Anderson’s study data for pegilodecakin is a confirmation for Eli Lilly, which gained pegilodecakin through its $1.6 billion acquisition of Armo Biosciences last year. When Eli Lilly bought the company, it wanted pegilodecakin to bolster its own immuno-oncology programs. At the time the deal was struck, pegilodecakin was in a number of trials, including recruiting for a Phase III clinical trial in pancreatic cancer. The Phase III trial is testing pegilodecakin combined with the chemo treatment Folfox against Folfox alone.
