The US Food and Drug Administration (FDA) has cleared Roche's Tecentriq (atezolizumab) and its subcutaneous formulation, Tecentriq Hybreza, as a post-surgery treatment for a specific form of colon cancer. When used alongside fluoropyrimidine and oxaliplatin chemotherapies, the regimen is indicated for patients with stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of highly mutated tumor. This milestone represents the twelfth US indication for the blockbuster immunotherapy.

“This approval provides a new adjuvant treatment option for people with stage III dMMR colon cancer who face a high risk of disease recurrence,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Tecentriq combined with chemotherapy has the potential to become the new standard of care as the first approved immunotherapy-based regimen for this setting.”

“Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status,” said Frank A. Sinicrope, MD, Professor of Oncology at the Mayo Clinic and US Principal Investigator for the Alliance ATOMIC trial. “This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection. By reducing the risk of disease recurrence or death by 50%, atezolizumab plus chemotherapy is a practice-changing regimen that can improve clinical outcomes of this group of patients living with colon cancer, one of the most common cancers and a leading cause of cancer-related death.”

The FDA approval is based on the landmark phase III ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to modified (m)FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, as determined by an immunohistochemistry test, such as the VENTANA MMR RxDx Panel.

 The 36-month disease-free survival was 86% for Tecentriq combined with mFOLFOX6 compared with 76% in the mFOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and mFOLFOX6.

Colon cancer remains one of the world's most common and deadliest tumours. Over one million people are diagnosed globally each year, and nearly 25% of all colon cancers are diagnosed at stage III.

Despite surgery and chemotherapy, nearly 30% of stage III patients experience disease recurrence within five years.Approximately 15% of colon cancer patients present with dMMR or microsatellite instability-high (MSI-H) tumours, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy.

Roche is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency, to bring this immunotherapy-based adjuvant option to patients with dMMR colon cancer worldwide as soon as possible.