Roche has 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 III deficient mismatch repair (dMMR) colon cancer.
The approval introduces an immunotherapy-based treatment option for patients with this specific type of colon cancer following surgery. According to Roche, the decision marks the first FDA-approved adjuvant immunotherapy regimen for stage III dMMR colon cancer and represents the 12th US indication for Tecentriq.
The FDA's decision is based on findings from the Phase III ATOMIC study, which evaluated Tecentriq in combination with modified FOLFOX6 chemotherapy against chemotherapy alone in patients with stage III dMMR colon cancer.
The study enrolled 712 patients and investigated whether adding atezolizumab to chemotherapy could improve disease-free survival following surgery. According to the trial results published in The New England Journal of Medicine, adding Tecentriq to chemotherapy reduced the risk of disease recurrence or death by 50% compared with chemotherapy alone.
The reported 36-month disease-free survival rate was 86% in patients receiving Tecentriq plus modified FOLFOX6, compared with 76% among those receiving modified FOLFOX6 alone. Roche also reported that the safety profile of the combination was consistent with the previously established safety profiles of Tecentriq and modified FOLFOX6.
In the ATOMIC trial, patients were assigned to one of two treatment groups.
The combination group received modified FOLFOX6 chemotherapy alongside Tecentriq for 12 cycles over six months, followed by Tecentriq monotherapy for another 13 cycles over six months.
The control group received modified FOLFOX6 chemotherapy alone for 12 cycles.
The primary endpoint of the study was disease-free survival, which assesses the time patients remain free from cancer recurrence or other specified events after treatment.
Deficient mismatch repair is a molecular characteristic associated with impaired DNA repair and increased mutation rates in tumour cells. Tumours with dMMR or microsatellite instability-high (MSI-H) characteristics may respond to immunotherapy, making this biomarker important for treatment decisions.
Roche estimates that approximately 15% of colon cancer patients have dMMR or MSI-H tumours. The company also notes that nearly one-quarter of colon cancers are diagnosed at stage III, and around 30% of patients with stage III disease experience recurrence within five years despite treatment.
Tecentriq is a monoclonal antibody that targets programmed death-ligand 1 (PD-L1). By blocking interactions between PD-L1 and its receptors, the medicine is designed to help reactivate T-cell immune responses against cancer.
Roche said it is pursuing additional regulatory filings for Tecentriq, including with the European Medicines Agency, to expand access to this adjuvant immunotherapy-based treatment option for eligible patients with dMMR colon cancer. The latest FDA approval strengthens Tecentriq's position in oncology and highlights the growing role of biomarker-based treatment approaches in cancer care.
