FDA approves Tecentriq combination as adjuvant treatment for stage III dMMR colon cancer

Roche has received U.S. Food and Drug Administration approval for Tecentriq, also known as atezolizumab, in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient mismatch repair colon cancer.

The approval also covers Tecentriq Hybreza, the subcutaneous formulation of atezolizumab combined with hyaluronidase.

The decision makes the regimen the first approved immunotherapy-based adjuvant treatment for patients with stage III dMMR colon cancer following surgery.

It also marks the twelfth U.S. indication for Tecentriq.

Approval was based on results from the Phase III ATOMIC study, which compared Tecentriq plus modified FOLFOX6 chemotherapy with chemotherapy alone.

The study showed that adding Tecentriq reduced the risk of disease recurrence or death by 50% compared with modified FOLFOX6 alone.

At 36 months, disease-free survival was 86% among patients receiving Tecentriq plus chemotherapy compared with 76% in the chemotherapy-only group.

The findings were also published in The New England Journal of Medicine.

Levi Garraway, MD, PhD, Chief Medical Officer and Head of Global Product Development at Roche, said the approval provides a new option for patients with stage III dMMR colon cancer who remain at substantial risk of recurrence after surgery.

He said the combination has the potential to establish a new standard of care in this setting.

Frank A. Sinicrope, MD, Professor of Oncology at Mayo Clinic and U.S. Principal Investigator for the Alliance ATOMIC study, said adjuvant treatment for stage III colon cancer has historically not differed according to mismatch repair status.

He said the latest approval introduces an approach that uses immunotherapy to target the biological characteristics of dMMR tumours following surgical resection.

The safety profile of Tecentriq plus modified FOLFOX6 was consistent with previously reported findings for the individual treatments.

No new safety concerns were highlighted in the Phase III analysis.

Colon cancer is among the most commonly diagnosed cancers worldwide, with more than one million new cases each year.

Around a quarter of colon cancers are diagnosed at stage III, and Roche said nearly 30% of patients with stage III disease experience recurrence within five years despite surgery and chemotherapy.

Approximately 15% of colon cancers are characterised by deficient mismatch repair or microsatellite instability-high status.

These tumours have higher mutation rates, which may make them more responsive to immunotherapy.

Roche said it is pursuing additional regulatory submissions for Tecentriq in this setting, including with the European Medicines Agency.

---

---

Related Topics and Keywords

adjuvant therapy, Atezolizumab, ATOMIC, Biopharma, chemotherapy, colon cancer, colorectal cancer, disease-free survival, dmmr, FDA Approval, immunotherapy, mFOLFOX6, mismatch repair deficiency, Oncology, pharma news, phase III, Roche, stage III colon cancer, TECENTRIQ, Tecentriq Hybreza