FDA Approves Tecentriq Plus Chemotherapy for Stage III dMMR Colon Cancer – Roche

Roche announced that the FDA has approved Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumour characterised by high mutation rates. This approval marks the twelfth indication for Tecentriq in the US.

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

 “Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status. 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.” – Frank A. Sinicrope, MD, Professor of Oncology at the Mayo Clinic and US Principal Investigator for the Alliance ATOMIC trial.

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.