Press release
Exelixis and Natera to Collaborate on STELLAR-316, a Phase 3 Pivotal Trial of Zanzalintinib for Patients with Colorectal Cancer
– STELLAR-316 will use Natera’s Signatera™ assay to identify MRD-positive patients for trial enrollment and to monitor response to therapy – ALAMEDA, Calif.
About this update from Natera, Inc.
[{"type":"text","content":"\n– STELLAR-316 will use Natera’s Signatera™ assay to identify MRD-positive patients for trial enrollment and to monitor response to therapy –\n\n\n ALAMEDA, Calif. & AUSTIN, Texas--(BUSINESS WIRE)--\nExelixis, Inc. (Nasdaq: EXEL) and Natera (Nasdaq: NTRA), a global leader in cell-free DNA and precision medicine, today announced their collaboration on the planned Exelixis-sponsored STELLAR-316 trial. This randomized phase 3 pivotal trial will evaluate zanzalintinib, Exelixis’ novel oral kinase inhibitor, with and without an immune checkpoint inhibitor, in patients with resected stage II/III colorectal cancer (CRC).\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260107329077/en/\nUsing Natera’s Signatera™ test following completion of definitive therapy*, patients with CRC who test positive for molecular residual disease (MRD) and have no radiographic evidence of disease will be eligible for enrollment in the STELLAR-316 trial. Working with patients and their providers, this trial will be fully enrolled with patients who are receiving commercial Signatera testing as part of their routine standard of care.\n\n\nThe primary endpoint of STELLAR-316 is disease-free survival. Signatera will also be used for longitudinal monitoring of circulating tumor DNA clearance, one of the secondary endpoints of the trial. Exelixis expects to initiate STELLAR-316 in mid-2026.\n\n\nCRC is the third most common cancer and the second leading cause of cancer-related deaths in the U.S.1 Of the approximately 89,000 stage II/III colorectal cancer cases projected for 2035,2 about 20% of these patients are expected to remain MRD-positive following definitive therapy.3 Patients with stage II/III CRC who are MRD-positive have been shown to experience worse outcomes in multiple clinical studies3,4,5 and there are no established or approved therapies for this specific patient population in the U.S.\n\n\n“Patients with colorectal cancer who are MRD-positive following definitive therapy face a high risk of recurrence, underscoring the urgent need for new treatment options that can help prevent clinical metastatic progression,” said Dana T. Aftab, Ph.D., Executive Vice President, Research and Development, Exelixis. “STELLAR-316 is our second pivotal trial of zanzalintinib in patients with CRC and rep...