|
Swiss pharma major Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) filing for adjuvant Tecentriq (atezolizumab) and Tecentriq Hybreza (atezolizumab and hyaluronidase-tqjs) in combination with chemotherapy in stage III deficient DNA mismatch repair (dMMR) or microsatellite instability-high (MSI-H) colon cancer, a type of tumour characterised by high mutation rates. The FDA has granted Priority Review and is expected to make a decision on the approval by October 9, 2026.
“This filing acceptance brings us closer to establishing adjuvant Tecentriq plus chemotherapy as a new standard of care for certain types of early colon cancer," said Levi Garraway, MD, PhD, Roche’s chief medical officer and head of global product development. “The ATOMIC results demonstrate that Tecentriq plus chemotherapy can substantially reduce the risk of disease recurrence or death, helping more patients remain cancer-free following surgery.”
"One in three patients with stage III colon cancer will relapse within five years, underscoring the need for new adjuvant treatment options,” said Michael Sapienza, CEO, Colorectal Cancer Alliance. “This milestone represents a critical step toward a reality where treatment is tailored to a patient’s specific tumor biology from the very beginning, giving them a better chance of preventing a recurrence."
The application is based on the ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to standard FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50%, compared to chemotherapy alone for people with stage III dMMR colon cancer, determined by an immunohistochemistry test, such as the Ventana MMR RxDx Panel.
The 36-month disease-free survival was 86% for Tecentriq combined with FOLFOX6 compared with 76% in the FOLFOX6 alone group. The safety profile was consistent with previous studies of Tecentriq and FOLFOX6.
Colon cancer remains one of the world's most common and deadliest tumours. Over one million people are diagnosed globally each year, and despite surgery and chemotherapy, approximately 30% of stage III patients relapse within five years. Approximately 15% of colon cancer patients present with dMMR/MSI-H tumours, which indicate a higher mutation rate and thus have the potential to respond to immunotherapy.
Roche is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency, to bring this first immunotherapy-based adjuvant option to patients with dMMR/MSI-H colon cancer worldwide, said the company.
The ATOMIC study was sponsored by the National Cancer Institute (NCI) and conducted by the Alliance for Clinical Trials in Oncology in partnership with Roche and the Arbeitsgemeinschaft Internistische Onkologie (AIO) group in Germany. It highlights Roche’s commitment to working alongside leading academic groups to tackle some of the most challenging cancers.
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1, which is expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.
Tecentriq has been approved for some of the most aggressive and difficult-to-treat forms of cancer, and is the first PD-(L)1 cancer immunotherapy available in both subcutaneous and intravenous formulations.
|