NEW YORK – Nektar Therapeutics and Merck on Wednesday announced plans to conduct a clinical trial of Nektar's IL-2 pathway agent bempegaldesleukin combined with pembrolizumab (Merck's Keytruda) as a first-line treatment for certain patients with PD-L1-positive head and neck cancer.
In the Phase II/III randomized clinical trial, expected to begin in the second half of 2021, the companies will evaluate the combination in patients with metastatic or unresectable, recurrent, squamous cell carcinoma of the head and neck. To be eligible for the trial, patients' tumors must express PD-L1 with a combined positive score of at least one.
The study is expected to enroll roughly 500 patients, who will be randomized to receive either the combination of pembrolizumab and bempegaldesleukin — also known as NKTR-214 and Bempeg — or pembrolizumab alone. The primary endpoint of the Phase II portion of the trial will be overall response rate, and should the trial continue on to Phase III, the primary endpoints will include overall survival and progression-free survival, in addition to overall response rate.
"Earlier studies of Bempeg in combination with immune checkpoint inhibitors … evaluated in patients with immune-sensitive cancers have shown the potential to increase and deepen treatment responses as compared to historical rates for ICIs alone," Jonathan Zalevsky, Nektar's chief R&D officer, said in a statement. "This collaboration with Merck will enable us to further explore the combination of Bempeg with the leading checkpoint inhibitor therapy in the setting of advanced head and neck cancer."