Jan. 7 at 5:00 PM
Exelixis and Natera announced a collaboration on a pivotal Phase 3 trial in resected stage II/III colorectal cancer patients. The study, called STELLAR-316, will evaluate Exelixis’ oral kinase inhibitor zanzalintinib, with or without an immune checkpoint inhibitor, in patients identified as having molecular residual disease (MRD) using Natera’s Signatera test.
The randomized trial targets a high-risk population with limited treatment options, as about 20% of stage II/III colorectal cancer patients remain MRD-positive after definitive therapy and face a high risk of recurrence. Disease-free survival will serve as the primary endpoint, with clearance of circulating tumor DNA as a key secondary endpoint. Exelixis expects to initiate the study in mid-2026, and success could position zanzalintinib as the first MRD-guided treatment in this setting.
$EXEL $NTRA