What's Happening?
Exelixis has announced detailed results from the STELLAR-303 Phase 3 trial evaluating zanzalintinib in combination with atezolizumab for metastatic colorectal cancer. The trial demonstrated a 20% reduction in the risk of death compared to regorafenib,
with improved median overall survival of 10.9 months versus 9.4 months. The study met one of its dual primary endpoints, showing consistent benefits across key subgroups of patients. The trial results were presented at the European Society for Medical Oncology Congress and published in The Lancet. Exelixis plans to submit a new drug application for zanzalintinib in the U.S. by the end of 2025.
Why It's Important?
The positive results from the STELLAR-303 trial offer a promising new treatment option for patients with previously treated metastatic colorectal cancer, a condition with limited effective therapies. The combination of zanzalintinib and atezolizumab could provide a chemotherapy-free alternative, potentially extending survival for patients. This development is significant given the high mortality rate associated with metastatic colorectal cancer, which is the second leading cause of cancer-related deaths in the U.S.
What's Next?
Exelixis intends to complete the submission of its first new drug application for zanzalintinib in the U.S. by the end of the year. The company is also continuing its robust clinical trial program to expand the scope of solid tumor types that zanzalintinib may address. The trial will proceed to the planned final analysis for the endpoint of overall survival in patients without liver metastases, which could further validate the drug's efficacy.
Beyond the Headlines
The trial results underscore the potential of immunotherapy-based treatments in oncology, particularly for challenging cancers like metastatic colorectal cancer. The success of zanzalintinib may encourage further research into kinase inhibitors and their role in cancer treatment, potentially leading to new therapeutic strategies for other solid tumors.
