What's Happening?
Exelixis, Inc. has announced promising results from its Phase 3 STELLAR-303 trial, which evaluated the combination of zanzalintinib and atezolizumab against regorafenib in patients with previously treated
non-microsatellite instability-high metastatic colorectal cancer. The trial demonstrated a 20% reduction in the risk of death for patients receiving the combination therapy, with a median overall survival of 10.9 months compared to 9.4 months for those on regorafenib. These findings were presented at the 2025 European Society for Medical Oncology Congress and published in The Lancet. The study also showed consistent benefits across various patient subgroups, including those with different geographic regions, RAS status, and liver involvement.
Why It's Important?
The results from the STELLAR-303 trial are significant as they offer a potential new treatment option for patients with metastatic colorectal cancer, a condition with limited effective therapies. The combination of zanzalintinib and atezolizumab could provide a chemotherapy-free alternative, extending survival for patients who have exhausted other treatments. This development is crucial given the high mortality rate associated with metastatic colorectal cancer, which is the second leading cause of cancer-related deaths in the U.S. The trial's success could lead to a new drug application submission in the U.S., potentially expanding treatment options for a patient population in dire need of new therapies.
What's Next?
Exelixis plans to complete the submission of a new drug application for zanzalintinib in the U.S. by the end of the year. The company aims to bring this combination therapy to market, providing a new option for patients with metastatic colorectal cancer. The trial will continue to its planned final analysis to further evaluate the overall survival benefits in patients without liver metastases. If approved, this treatment could significantly impact the standard of care for colorectal cancer, offering hope to patients and potentially influencing future research and development in oncology.
Beyond the Headlines
The introduction of zanzalintinib as a treatment option could shift the landscape of colorectal cancer therapy, emphasizing the role of targeted kinase inhibitors in oncology. This development highlights the importance of personalized medicine and the need for continued research into combination therapies that can address the complex biology of cancer. The trial's success also underscores the potential of immunotherapy in treating solid tumors, paving the way for further exploration of similar therapeutic strategies in other cancer types.
