Roche recently announced that the US Food and Drug Administration (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 3 deficient DNA mismatch repair (dMMR) colon cancer, a type of tumor characterised by high mutation rates. This approval marks the twelfth indication for Tecentriq in the US.

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development, Roche, said, “This approval provides a new adjuvant treatment option for people with stage 3 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.”

The FDA approval is based on the landmark phase 3 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 percent, compared to chemotherapy alone for people with stage 3 dMMR colon cancer, as determined by an immunohistochemistry test, such as the VENTANA MMR RxDx Panel. The 36-month Disease-Free Survival (DFS) was 86 percent for Tecentriq combined with mFOLFOX6 compared with 76 percent in the mFOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and mFOLFOX6.

Frank A Sinicrope, MD, Professor of Oncology, Mayo Clinic and US Principal Investigator for the Alliance ATOMIC trial, said, “Until now, the adjuvant Standard of Care for stage 3 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 3 colon cancer after surgical resection. By reducing the risk of disease recurrence or death by 50 percent, 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.”

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