FDA approves Tecentriq with chemo after trial shows 50% lower recurrence risk

The FDA approved Roche's Tecentriq (atezolizumab) and Tecentriq Hybreza with fluoropyrimidine- and oxaliplatin-based chemotherapy, including mFOLFOX6, as adjuvant treatment for stage III dMMR colon cancer. It is the drug's 12th U.S. indication. ATOMIC drove the decision. Adding Tecentriq cut the risk of disease recurrence or death by 50%. Three-year disease-free survival was 86% with the combination versus 76% with chemotherapy alone. The Phase 3 trial enrolled 712 patients. One arm got mFOLFOX6 plus Tecentriq for 12 cycles, then Tecentriq alone for 13; the other got mFOLFOX6 alone for 12. Disease-free survival was the primary endpoint. The National Cancer Institute sponsored the study, the Alliance for Clinical Trials in Oncology led it, and results appeared in The New England Journal of Medicine. Roche says nearly 25% of colon cancers are diagnosed at stage III and about 30% of stage III patients recur within five years despite surgery and chemotherapy. The firm is seeking approval in other markets.