The US Food and Drug Administration (FDA) has approved Roche’s Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs), in combination with a fluoropyrimidine and oxaliplatin, for the adjuvant treatment of stage III deficient mismatch repair (dMMR) colon cancer. These tumours are characterised by defects in the DNA mismatch repair system, which can lead to a high mutation rate.
According to Roche, the approval marks the 12th indication for Tecentriq in the US.
The FDA’s decision is based on results from the phase III ATOMIC study, published in The New England Journal of Medicine. The study demonstrated that adding Tecentriq to modified FOLFOX6 (mFOLFOX6) chemotherapy reduced the risk of disease recurrence or death by 50% compared with chemotherapy alone in patients with stage III dMMR colon cancer.
At 36 months, disease-free survival was 86% among patients treated with Tecentriq plus mFOLFOX6, compared with 76% among those receiving mFOLFOX6 alone.
“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, Roche’s chief medical officer and head of global product development.
He added that Tecentriq in combination with chemotherapy could become the new standard of care, as the first approved immunotherapy-based regimen for this setting.
Frank A. Sinicrope, professor of oncology at the Mayo Clinic and US principal investigator for the Alliance ATOMIC trial, said that, until now, the adjuvant standard of care for stage III colon cancer had not differed based on mismatch repair status.
“This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection,” he added.
Roche is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency, to make this immunotherapy-based adjuvant option available to patients with dMMR colon cancer worldwide.
Colon cancer: Disease burden and recurrence risk
Colon cancer is one of the most common cancers worldwide and a leading cause of cancer-related deaths.
According to data cited by Roche, more than one million people are diagnosed with colon cancer globally each year, with nearly 25% of cases diagnosed at stage III. Despite surgery and chemotherapy, nearly 30% of patients with stage III disease experience recurrence within five years.
Approximately 15% of colon cancer cases are characterised by dMMR or microsatellite instability-high (MSI-H) tumours. These features are associated with a higher mutation rate and may make the tumours more responsive to immunotherapy.
About Tecentriq
Tecentriq is a monoclonal antibody designed to bind to programmed death-ligand 1 (PD-L1), a protein expressed on tumour cells and tumour-infiltrating immune cells. By blocking interactions between PD-L1 and the PD-1 and B7.1 receptors, the treatment is intended to help reactivate T cells to mount an immune response against cancer.
Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer. It is also the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations.
