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Exelixis Announces Initiation of the STELLAR-305 Phase 2/3 Pivotal Trial Evaluating Zanzalintinib in Combination with Pembrolizumab in Patients with Previously Untreated Recurrent or Metastatic Head and Neck Cancer
– STELLAR-305 is Exelixis’ first pivotal study in squamous cell carcinoma of the head and neck – – Trial will evaluate the potential of inhibition of VEGF,
About this update from Exelixis, Inc.
[{"type":"text","content":"\n– STELLAR-305 is Exelixis’ first pivotal study in squamous cell carcinoma of the head and neck –\n\n\n– Trial will evaluate the potential of inhibition of VEGF, MET and AXL, which are elevated in these tumors –\n\n\n ALAMEDA, Calif.--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) today announced the initiation of STELLAR-305, a phase 2/3 pivotal trial evaluating zanzalintinib in combination with pembrolizumab versus pembrolizumab alone in patients with previously untreated PD-L1-positive recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).\n\n\n“We are excited to progress zanzalintinib, our next-generation multi-targeted tyrosine kinase inhibitor, into this population of patients who otherwise are relegated to immunotherapy plus chemotherapy, but may benefit from a chemo-free option,” said Amy Peterson, M.D., Executive Vice President, Product Development & Medical Affairs, and Chief Medical Officer, Exelixis. “This study is based on encouraging data from a phase 2 investigator-initiated trial of cabozantinib and pembrolizumab and demonstrates our agility to move quickly into indications with sound rationale from our flagship asset.”\n\n\nSTELLAR-305 is a global, multicenter, randomized, double-blind phase 2/3 study that will enroll patients with PD-L1-positive recurrent or metastatic SCCHN that is incurable with local therapies. Patients must not have received prior systemic therapy for recurrent or metastatic disease. Patients will be randomized 1:1 to receive zanzalintinib in combination with pembrolizumab or placebo in combination with pembrolizumab. The primary endpoints of the study are progression-free survival (PFS) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 by Blinded Independent Radiology Committee (BIRC) and overall survival. Secondary endpoints include PFS per RECIST 1.1 by investigator and objective response rate and duration of response per RECIST 1.1 by BIRC and by investigator.\n\n\nSTELLAR-305 is sponsored by Exelixis. More information about STELLAR-305 is available at ClinicalTrials.gov.\n\n\nAbout Zanzalintinib\n\n\nZanzalintinib is a next-generation oral tyrosine kinase inhibitor that inhibits the activity of receptor tyrosine kinases implicated in cancer growth and spread, including VEGF receptors, MET, AXL and MER. These receptor tyrosine kinases are involved i...