Roche’s Tecentriq and Tecentriq Hybreza, combined with chemotherapy, received FDA Priority Review as adjuvant treatment for resected stage III dMMR/MSI-H colon cancer. ATOMIC Phase III data showed a 50% reduction in recurrence risk. A decision is expected by October 2026.
Written By: Kalyani Boharapi,
M. Pharm (Reg. Affairs)
Reviewed By: Pharmacally Editorial Team
Roche has received FDA Priority Review for its supplemental Biologics License Application (sBLA) seeking approval of Tecentriq® (atezolizumab) and Tecentriq Hybreza® in combination with chemotherapy as adjuvant treatment for patients with resected stage III deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer.
The application covers both intravenous Tecentriq and Tecentriq Hybreza, the subcutaneous formulation of atezolizumab. The FDA is expected to make a decision by October 9, 2026.
If approved, the regimen would become the first immunotherapy-based adjuvant treatment specifically indicated for patients with stage III dMMR/MSI-H colon cancer following surgery.
ATOMIC Data Support Filing
The submission is based on results from the Phase III ATOMIC study (Alliance A021502; NCT02912559), which evaluated Tecentriq plus standard FOLFOX6 chemotherapy in patients with resected stage III dMMR colon cancer.
The trial met its primary endpoint, demonstrating a statistically significant 50% reduction in the risk of disease recurrence or death compared with chemotherapy alone (HR=0.50). At 36 months, disease-free survival rates were 86% for patients receiving Tecentriq plus FOLFOX6 versus 76% for those receiving chemotherapy alone.
The findings, recently published in The New England Journal of Medicine, mark the first Phase III study to show a significant disease-free survival benefit with adjuvant immunotherapy in resected stage III dMMR colon cancer.
The safety profile of the combination was consistent with the known profiles of Tecentriq and FOLFOX6, with no new safety signals identified. Overall survival data remain immature and continue to be monitored.
Addressing an Unmet Need
Colon cancer remains a leading cause of cancer-related death worldwide. Despite surgery and adjuvant chemotherapy, approximately 30% of patients with stage III disease experience recurrence within five years.
Patients with dMMR/MSI-H tumors represent roughly 15% of colon cancer cases and have shown strong responsiveness to immune checkpoint inhibitors in advanced disease. However, no immunotherapy-based adjuvant treatment is currently approved for this patient population.
Company and Advocacy Perspectives
Levi Garraway, M.D., Ph.D., Roche’s Chief Medical Officer and Head of Global Product Development, said the FDA’s acceptance of the application represents an important step toward bringing a new treatment option to patients with early-stage dMMR colon cancer who remain at risk of recurrence following surgery.
Michael Sapienza, Chief Executive Officer of the Colorectal Cancer Alliance, noted that recurrence remains a major challenge for patients with stage III disease and highlighted the importance of expanding biomarker-driven treatment approaches.
Potential Practice Impact
The FDA’s Priority Review positions Tecentriq as a potential new treatment option for patients with resected stage III dMMR/MSI-H colon cancer. Supported by Phase III data demonstrating a significant reduction in recurrence risk, the application could establish the first immunotherapy-based adjuvant standard for this molecularly defined population. An FDA decision is expected in October 2026.
Reference
FDA grants Priority Review for Roche’s Tecentriq for a certain type of stage III colon cancer
About the Writer
Kalyani Boharapi (LinkedIn) is a pharmacy professional and healthcare writer currently pursuing an M.Pharm in Regulatory Affairs at Dr. D. Y. Patil College of Pharmacy, with interests in pharmaceutical regulations, drug development, and healthcare innovation. She has academic exposure to dossier preparation, scientific writing, and regulatory documentation. Kalyani has also completed certification courses in Generative AI, AI in Pharma, and Bioinformatics, and actively participates in pharmaceutical conferences to stay updated with emerging trends and advancements in the healthcare and pharmaceutical industry.