Roche revealed receipt of US FDA approval for 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. The decision establishes the first approved immunotherapy-based regimen in this post-surgical setting, expanding treatment beyond chemotherapy alone, and is Tecentriq's 12th approved indication in the US.
The approval was supported by the Phase III ATOMIC trial (NCT02912559), in which adding atezolizumab to mFOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50% compared with chemotherapy alone (HR 0.50; p<escape><</escape>0.001). Three-year disease-free survival was 86.3% versus 76.2%, respectively. Grade 3 or 4 adverse events occurred in 84.1% of patients receiving the combination versus 71.9% in the control group. The 712-patient study was sponsored by the US National Cancer Institute, with results published in the New England Journal of Medicine in March 2026.
The intravenous Tecentriq approval covers patients aged 2 years and older, while Tecentriq Hybreza is approved for patients aged 12 years and older weighing at least 40 kg. The regimen comprises six months of atezolizumab alongside chemotherapy, followed by six months of atezolizumab monotherapy.