First-in-Human Biologic Drug Combination for Metastatic Lung Cancer
Posted: Wednesday, January 17, 2018
The results of a first-in-human phase Ib trial indicate that combining the interleukin (IL)-15 superagonist ALT-803 with the anti–PD-1 monoclonal antibody nivolumab may safely improve outcomes in patients with metastatic non–small cell lung cancer (NSCLC). John Wrangle, MD, MPH, of the Medical University of South Carolina in Charleston, presented his team’s findings at the recent American Association for Cancer Research–International Association for the Study of Lung Cancer (AACR-IASLC) International Joint Conference: Lung Cancer Translational Science from the Bench to the Clinic (Abstract PR05) in San Diego.
A total of 21 patients with metastatic NSCLC, all eligible to initiate or continue receiving nivolumab after first-line therapy, were given nivolumab along with ALT-803 as second-line therapy on 1 of 4 dosing schedules. The investigators reported multiple objective responses and no dose-limiting toxicities with the combination therapy. Fever, flu-like symptoms, and injection-site reactions were the most common adverse events noted.
The team determined a recommended phase II dose of weekly subcutaneous ALT-803 at 20 mg/kg in combination with intravenous nivolumab at 240 mg every 14 days.
“Responses among patients with PD-1 monoclonal antibody–relapsed disease with the addition of ALT-803 to their regimen demonstrate for the first time evidence of antitumor activity for a new class of agents for NSCLC and in patients with disease progression on PD-1/PD-L1 pathway blockade,” Dr. Wrangle and colleagues stated in their abstract.
