Study of XL092 + Atezolizumab vs Regorafenib in Participants With Metastatic Colorectal Cancer
Summary
The primary purpose of this study is to evaluate XL092 + atezolizumab versus regorafenib in participants with microsatellite stable/microsatellite instability low (MSS/MSI-low) metastatic colorectal cancer (mCRC) who have progressed during, after or are intolerant to standard-of-care (SOC) therapy.
Timeline
- Start
- 2022-09-07
- Primary completion
- 2026-06-16
- Completion
- 2027-01-31
Outcome
Sources disagree · no verdict is set; each source's reading is shown below
paper Dual primary endpoints were overall survival in the intention-to-treat (ITT) population and in the subset of patients without liver metastases. reads as mixed primary results PMID 41130252 ↗
paper zanzalintinib-atezolizumab showed a significant overall survival benefit versus regorafenib in the ITT population (stratified hazard ratio [HR] 0·80 [95% CI 0·69-0·93]; p=0·0045) reads as mixed primary results PMID 41130252 ↗
paper the stratified HR for zanzalintinib-atezolizumab versus regorafenib was 0·79 (95% CI 0·61-1·03); p=0·087 reads as mixed primary results PMID 41130252 ↗
release “positive topline results from the STELLAR-303 phase 3 pivotal trial in which zanzalintinib in combination with atezolizumab (Tecentriq®) demonstrated a statistically significant improvement” reads as met primary endpoint exelixis.com ↗
release “Exelixis previously announced that STELLAR-303 met its other dual primary endpoint, demonstrating a statistically significant improvement in OS in the ITT population.” reads as mixed primary results exelixis.com ↗
release “The results showed a non-statistically significant trend in OS favoring the combination in the NLM subpopulation” reads as mixed primary results exelixis.com ↗
Publications
- Hecht JR, Park YS, Tabernero J, Lee MA, Lee S, Virgili AC, Van den Eynde M, Fontana E, Fakih M, Asghari G, So J, Stein A, Dubreuil O, Bodnar L, He CS, Wang G, Smith R, Eng C, Saeed A; STELLAR-303 study investigators. Zanzalintinib plus atezolizumab versus regorafenib in refractory colorectal cancer (STELLAR-303): a randomised, open-label, phase 3 trial. Lancet. 2025 Nov 15;406(10517):2360-2370. doi: 10.1016/S0140-6736(25)02025-2. Epub 2025 Oct 20.
- Saeed A, Tabernero J, Parikh A, Van den Eynde M, Karthaus M, Gerlinger M, Wang Z, Wang G, Smith R, Hecht JR. STELLAR-303: randomized phase III study of zanzalintinib + atezolizumab in previously treated metastatic colorectal cancer. Future Oncol. 2024;20(24):1733-1743. doi: 10.1080/14796694.2024.2352276. Epub 2024 Jul 23.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Atezolizumab | Monoclonal antibody | 1200 mg | Intravenous |
| Comparator | Regorafenib | Small molecule | 160 mg | Oral |
| Subject | Zanzalintinib | Small molecule | 100 mg | Oral |