The FDA approved Tecentriq plus chemotherapy for stage III dMMR colon cancer, Roche’s 12th US indication for the immunotherapy.
Roche has added a twelfth US indication to Tecentriq (atezolizumab). The FDA approved the programmed death-ligand 1 (PD-L1) inhibitor and its subcutaneous formulation with hyaluronidase-tqjs (Tecentriq Hybreza) for adjuvant treatment of stage III colon cancer with deficient DNA mismatch repair (dMMR), the company announced Oct. 9.1
The regimen pairs the immunotherapy with a fluoropyrimidine and oxaliplatin in a biomarker-defined patient group.1
“This approval provides a new adjuvant treatment option for people with stage III dMMR colon cancer who face a high risk of disease recurrence,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “Tecentriq combined with chemotherapy has the potential to become the new standard of care as the first approved immunotherapy-based regimen for this setting.”1
Tecentriq generated CHF 1.70 billion in sales in the first half of 2026, including CHF 815 million in the US, according to Roche’s half-year report.2 The company said the FDA granted the colon cancer application priority review earlier this year.2
The new indication moves the brand into an earlier, curative-intent setting, but the announcement included no sales projections, and the eligible population is a subset. Roche estimates that about 15% of colon cancers are dMMR or microsatellite instability–high and that nearly 25% of colon cancers are diagnosed at stage III.1
Two features of the approval bear on uptake. Eligibility depends on an immunohistochemistry test of mismatch repair status, such as the Ventana MMR RxDx Panel, so testing becomes part of the adoption path.1
The label also spans intravenous and subcutaneous formulations, which Roche says makes Tecentriq the first immunotherapy targeting the programmed death-1 or PD-L1 pathway available in both.1
The approval rests on ATOMIC (Alliance A021502; NCT02912559), a phase 3, randomized, open-label trial of 712 patients with resected stage III dMMR colon cancer.1 Participants received modified FOLFOX6 (mFOLFOX6) plus atezolizumab for 12 cycles followed by 13 cycles of atezolizumab alone, or mFOLFOX6 alone for 12 cycles.
Disease-free survival was the primary endpoint.1,3 The National Cancer Institute sponsored the study, and Genentech, a Roche Group member, provided support through a cooperative research and development agreement.1
Roche reports a 50% reduction in the risk of recurrence or death, with 36-month disease-free survival of 86% versus 76% for chemotherapy alone.1 In the published results, grade 3 or 4 adverse events occurred in 84.1% of patients receiving the combination and 71.9% of those receiving mFOLFOX6 alone.3
A summary of the paper reports five-year overall survival of 89.7% and 87.9% (hazard ratio, 0.90; 95% confidence interval, 0.55-1.47) and two treatment-related deaths in the combination arm.4
Roche cites more than 1 million colon cancer diagnoses worldwide each year and says nearly 30% of stage III patients experience recurrence within five years despite surgery and chemotherapy.1
“Until now, the adjuvant standard of care for stage III colon cancer has not differed based on mismatch repair status,” said Frank A. Sinicrope, MD, Professor of Oncology at the Mayo Clinic and US principal investigator for ATOMIC. “This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection.”1
Sinicrope led the trial globally and is the corresponding author of its publication.1,4 His assessment and Garraway’s standard-of-care language come from the sponsor’s side of the data and the lead investigator.
The evidence is a single open-label phase 3 trial in a molecularly defined subgroup. Disease-free survival supported the approval, while the confidence interval around five-year overall survival is wide and includes no difference.4
Higher rates of grade 3 or 4 events with the combination are a consideration in patients treated with curative intent after surgery.3 Guideline positioning and the final label language were not available in the materials reviewed.
Roche is pursuing further regulatory filings, including with the European Medicines Agency.1 Whether regulators outside the US accept the same data, and how quickly mismatch repair testing is adopted in practice, remain open questions.
