On February 17, 2021 Nektar Therapeutics (NASDAQ: NKTR) reported that it has entered into a clinical trial collaboration and supply agreement with Merck (known as MSD outside the United States and Canada) for a Phase 2/3 study of bempegaldesleukin (NKTR-214, BEMPEG), Nektar’s investigational IL-2 pathway agent, in combination with Merck’s KEYTRUDA (pembrolizumab) for first-line treatment of patients with metastatic or unresectable recurrent squamous cell carcinoma of the head and neck (SCCHN) whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) (Press release, Nektar Therapeutics, FEB 17, 2021, View Source [SID1234575223]). The study is planned to start in the second half of 2021.
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"We are excited to advance the combination of BEMPEG plus KEYTRUDA to a Phase 2/3 study in first-line squamous cell carcinoma of the head and neck," said Jonathan Zalevsky, PhD, Chief R&D Officer at Nektar. "Earlier studies of BEMPEG in combination with immune checkpoint inhibitors, also known as ICIs, 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. 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."
Under the terms of the agreement, Nektar will conduct the Phase 2/3 study, which is expected to enroll 500 patients with metastatic or recurrent SCCHN with PD-L1 expressing tumors. Patients will be randomized to receive either the combination of BEMPEG plus pembrolizumab or pembrolizumab alone. The Phase 2 portion of the study will include an interim analysis of overall response rate (ORR) after the first 200 patients enrolled have a minimum follow up of 4 months. If the ORR passes a prespecified futility boundary, the study will continue, and the remaining 300 patients will be enrolled to the Phase 3 portion of the study. The primary endpoints of the trial are ORR and overall survival (OS); progression free survival (PFS) is a secondary endpoint.