What's Happening?
Exelixis is advancing towards a regulatory application with the FDA for its oral kinase inhibitor, zanzalintinib, following promising results from the Phase III STELLAR-303 study. This study demonstrated
that zanzalintinib, in combination with Roche’s Tecentriq, significantly improved overall survival rates in patients with metastatic colorectal cancer. The median overall survival for patients treated with this combination was 10.9 months, compared to 9.4 months for those treated with Bayer’s Stivarga. The study, which involved over 900 patients, was presented at the 2025 European Society for Medical Oncology meeting and published in The Lancet. Exelixis plans to submit a regulatory application by the end of the year.
Why It's Important?
The results from the STELLAR-303 study set a new benchmark for survival in third-line metastatic colorectal cancer treatment, potentially impacting treatment protocols and patient outcomes. The success of zanzalintinib could lead to significant market opportunities, with projected U.S. sales reaching $850 million at peak. However, the treatment's safety profile, with 59% of patients experiencing severe toxicities, raises concerns about its risk-benefit ratio. The potential for increased side effects and costs due to the combination with Tecentriq may affect patient accessibility and acceptance.
What's Next?
Exelixis is expected to submit a regulatory application for zanzalintinib to the FDA by the end of 2025. If approved, this could lead to a new treatment option for patients with metastatic colorectal cancer. The company and stakeholders will likely monitor the FDA's response closely, as approval could significantly impact Exelixis' market position and financial performance. Additionally, discussions around the treatment's safety and cost implications may continue among healthcare providers and patient advocacy groups.
Beyond the Headlines
The development of zanzalintinib highlights the ongoing innovation in cancer treatment, particularly in targeting specific pathways like kinase inhibition. This approach may pave the way for more personalized and effective cancer therapies. However, the ethical considerations of balancing treatment efficacy with potential side effects and costs remain a critical discussion point in the medical community.
