Authorisation positions monoclonal antibody as a new post-surgery standard of care in stage III deficient mismatch repair colon cancer.
Roche’s Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin has been approved as the first adjuvant immunotherapy regimen for stage III dMMR colon cancer.
The US Food and Drug Administration (FDA)’s authorisation positions the treatment as a new post-surgery standard of care for the common tumour, as evidenced by meaningful clinical findings that formed the agency’s decision. The regimen is indicated as an adjuvant therapy for patients with the deficient DNA mismatch repair (dMMR) form of the disease.
Dr Frank Sinicrope, Professor of Oncology at the Mayo Clinic and US Principal Investigator for the Phase III ATOMIC (A021502) study said: “Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status.”
“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”
Dr Frank Sinicrope, Professor of Oncology at the Mayo Clinic and US Principal Investigator for the Phase III ATOMIC (A021502) study
He added that based on findings from the Phase III ATOMIC trial published in The New England Journal of Medicine, “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 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.”
As 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,” according to Dr Levi Garraway, 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.”
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