FDA approves Tecentriq and chemotherapy for stage III dMMR colon cancer

The FDA has approved atezolizumab (Tecentriq) in combination with chemotherapy for the adjuvant treatment of patients aged 2 years and older with resected stage III mismatch repair deficient (dMMR) colon cancer. The approval is based on results from the phase 3 ATOMIC trial, which demonstrated that combining Tecentriq with chemotherapy lowered the risk of cancer recurrence or death by 50% compared to chemotherapy alone.

The treatment regimen involves chemotherapy consisting of a fluoropyrimidine and oxaliplatin. For patients 12 years and older weighing 40 kg or more, the FDA also approved Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), which is administered as a subcutaneous injection.

In the ATOMIC trial, which included 711 adults and one pediatric patient, the median disease-free survival was not reached in either the combination group or the chemotherapy-only group, indicating that more than half of the participants in both groups remained alive without cancer recurrence at the time of analysis.