FDA approves atezolizumab and chemotherapy for stage III dMMR colon cancer

The FDA approved atezolizumab (Tecentriq) with a fluoropyrimidine and oxaliplatin as adjuvant treatment for adults and children aged 2 years and older with stage III mismatch repair deficient (dMMR) colon cancer. It also approved atezolizumab and hyaluronidase-tqjs (Tecentriq Hybreza) for patients aged 12 years and older who weigh 40 kg or greater.

The approval was based on the ATOMIC trial, which included 711 adults and one pediatric patient after complete tumor resection. Patients received atezolizumab plus chemotherapy for 12 cycles, followed by atezolizumab alone for 6 months, or chemotherapy alone for 12 cycles. The FDA reported a hazard ratio for disease-free survival of 0.50 (95% CI: 0.35, 0.73). MedPage Today reported 3-year disease-free survival rates of 86% with atezolizumab and chemotherapy and 76% with chemotherapy alone. Grade ≥3 adverse events occurred in 71.7% and 62.1% of patients, respectively, according to MedPage Today.