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Opinion|Videos|June 8, 2026

STELLAR 316: Trial Design and Future Directions for Zanzalintinib-Based Therapy

Author(s)Anwaar Saeed, MD, Daniel H. Ahn, DO

Dr. Saeed describes the rationale and design of STELLAR 316, a three-arm phase 3 trial evaluating zanzalintinib-based therapy in patients with stage III MSS colorectal cancer who test positive for circulating tumor DNA following surgery and adjuvant chemotherapy.

Episodes in this series

$EP. 1 Treatment Landscape and Sequencing Challenges in Refractory Non-MSI-High Metastatic Colorectal Cancer$

EP. 1 Treatment Landscape and Sequencing Challenges in Refractory Non-MSI-High Metastatic Colorectal Cancer

EP. 2 Immunosuppressive Tumor Microenvironment in Colorectal Cancer and the Rationale for Combination Immunotherapy

EP. 2 Immunosuppressive Tumor Microenvironment in Colorectal Cancer and the Rationale for Combination Immunotherapy

EP. 3 Lessons from Early Phase TKI-Immunotherapy Combinations and the Development of Zanzalintinib

EP. 3 Lessons from Early Phase TKI-Immunotherapy Combinations and the Development of Zanzalintinib

EP. 4 STELLAR 303: Trial Design and Efficacy Outcomes of Zanzalintinib Plus Atezolizumab

EP. 4 STELLAR 303: Trial Design and Efficacy Outcomes of Zanzalintinib Plus Atezolizumab

EP. 5 Safety Profile, Dose Management, and Treatment Positioning of Zanzalintinib Plus Atezolizumab

EP. 6 Integrating Biomarker-Targeted Therapies in the Evolving Metastatic Colorectal Cancer Landscape

EP. 6 Integrating Biomarker-Targeted Therapies in the Evolving Metastatic Colorectal Cancer Landscape

EP. 7 STELLAR 316: Trial Design and Future Directions for Zanzalintinib-Based Therapy

EP. 7 STELLAR 316: Trial Design and Future Directions for Zanzalintinib-Based Therapy

EP. 8 Key Takeaways from STELLAR 303 and Implications for Treating MSS Metastatic Colorectal Cancer

EP. 8 Key Takeaways from STELLAR 303 and Implications for Treating MSS Metastatic Colorectal Cancer

Dr. Saeed describes the rationale and design of STELLAR 316, a three-arm phase 3 trial evaluating zanzalintinib-based therapy in patients with stage III MSS colorectal cancer who test positive for circulating tumor DNA following surgery and adjuvant chemotherapy. This minimal residual disease population was selected based on data from STELLAR 303 showing superior outcomes in patients without liver metastasis and the absence of an established standard of care for ctDNA-positive patients after curative-intent treatment. STELLAR 316 randomizes participants to zanzalintinib plus pembrolizumab, zanzalintinib monotherapy, or placebo, with progression-free survival and overall survival as endpoints. The use of pembrolizumab rather than atezolizumab is deliberate, informed by data suggesting that anti-drug antibodies specific to atezolizumab may attenuate efficacy. Dr. Saeed also reviews additional data needs in the field, including prospective redosing strategy data, quality of life outcomes from STELLAR 303, and an upcoming ASCO abstract examining the contribution of individual components in STELLAR 303.

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