ASCO GI 2024 | Rationale and design of STELLAR-303: zanzalintinib + atezolizumab vs regorafenib in MSS/MSI-low mCRC

Anwaar Saeed, MD, University of Pittsburgh Medical Center, Pittsburgh, PA, discusses the rationale of the ongoing pivotal Phase III STELLAR-303 (NCT05425940) trial which aims to address the unmet need in patients with microsatellite stable/microsatellite instability-low (MSS/MSI-low) metastatic colorectal cancer (mCRC). Given the limited efficacy of immune checkpoint inhibitors (ICIs) alone, the trial investigates the combination of the novel multi-kinase inhibitor, zanzalintinib, and the anti–PD-L1 ICI, atezolizumab, comparing it with regorafenib. The rationale is based on preclinical data showing synergy between VEGF tyrosine kinase inhibitors and immunotherapy, making the tumor microenvironment more immune-permissive. The previous Phase I/II COSMIC-021 (NCT03170960) of cabozantinib with atezolzimuab have shown encouraging results, justifying the launch of STELLAR-303. The trial aims to enroll around 870 patients with primary endpoints focused on overall survival in patients without liver metastases. Interim data will be presented in future meetings. This interview took place at the 2024 ASCO Gastrointestinal (GI) Cancers Symposium in San Francisco, CA.

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