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The FDA has approved atezolizumab (Tecentriq) plus chemotherapy as the first adjuvant immunotherapy regimen for stage III mismatch repair–deficient (dMMR) colon cancer. Data from the phase 3 ATOMIC trial showed the combo slashed the risk of disease recurrence or death by 50% compared to chemo alone. Both an IV and a subcutaneous formulation received the green light.
The FDA has approved atezolizumab (Tecentriq) in combination with fluoropyrimidine and oxaliplatin as adjuvant treatment for stage III mismatch repair–deficient (dMMR) colon cancer — marking the first immunotherapy regimen approved for this specific setting. A subcutaneous formulation, atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza), also received approval for eligible patients aged 12 and older weighing at least 40 kg.
The approval was based on the phase 3 ATOMIC trial, which enrolled 712 patients with stage III dMMR colon cancer following complete surgical resection. Patients received either atezolizumab plus mFOLFOX6 for 12 cycles followed by atezolizumab monotherapy for 6 months, or mFOLFOX6 alone. The atezolizumab arm showed a significant improvement in disease-free survival, with median DFS not reached in either arm.
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Why it matters: Until now, adjuvant treatment for stage III colon cancer didn't differ based on mismatch repair status. This approval changes the standard of care for dMMR patients — a biologically distinct group — offering a targeted immunotherapy approach that meaningfully reduces recurrence risk after surgery.