FDA approves Roche’s Tecentriq in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of a certain type of stage III colon cancer
ATOMIC showed a 50% reduction in the risk of disease recurrence or death with Tecentriq plus chemotherapy versus chemotherapy alone.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Roche (RHHBY) received FDA approval for Tecentriq and Tecentriq Hybreza with chemotherapy as post-surgery treatment for stage III dMMR colon cancer. The approval covers combination treatment with a fluoropyrimidine and oxaliplatin for tumours deficient in DNA mismatch repair (dMMR), the system that repairs DNA errors. It marks Tecentriq’s twelfth US indication.
The phase III ATOMIC study enrolled 712 patients and showed that Tecentriq plus modified FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by 50% compared with chemotherapy alone. At 36 months, disease-free survival was 86% versus 76%, respectively. The safety profile was consistent with previous studies of Tecentriq and modified FOLFOX6. Roche is pursuing further regulatory filings, including with the European Medicines Agency.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Hollow bars mark forward-looking points. How the balance works
Positive
- Major pointATOMIC showed 50% lower risk of disease recurrence or death with Tecentriq plus modified FOLFOX6 versus chemotherapy alone.
- Moderate pointFDA approval of Tecentriq and Tecentriq Hybreza with chemotherapy for stage III dMMR colon cancer marks Tecentriq’s twelfth US indication.
- Minor point36-month disease-free survival was 86% with Tecentriq plus modified FOLFOX6 versus 76% with modified FOLFOX6 alone.
- Minor pointSafety profile was consistent with previous studies of Tecentriq and modified FOLFOX6.
- Minor point. Forward-looking: it has not happened yet and may not happen.Roche is pursuing further regulatory filings, including with the European Medicines Agency.
Negative
- None.
AI-generated analysis. How Rhea-AI works. Not financial advice.
- FDA approval is based on results from the landmark phase III ATOMIC study, published in The New England Journal of Medicine, which showed Tecentriq plus chemotherapy reduced the risk of disease recurrence or death by
50% compared to chemotherapy alone1 - First approved adjuvant immunotherapy regimen for stage III dMMR colon cancer, positioning Tecentriq as a new post-surgery standard of care
- Nearly
25% of all colon cancers are diagnosed at stage III, and almost one in three patients with stage III colon cancer experience a recurrence within five years2,3 - Approval marks the twelfth indication for Tecentriq in the US
Basel, 9 October 2026 - Roche (SIX: RO, ROP; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza® (atezolizumab and hyaluronidase-tqjs) in combination with a fluoropyrimidine and oxaliplatin for the adjuvant treatment of stage III deficient DNA mismatch repair (dMMR) colon cancer, a type of tumour characterised by high mutation rates. This approval marks the twelfth indication for Tecentriq in the US.
“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.”
“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 the Alliance ATOMIC trial. “This milestone represents an important therapeutic advance that leverages immunotherapy to target the specific biology of dMMR stage III colon cancer after surgical resection. By reducing the risk of disease recurrence or death by
The FDA approval is based on the landmark phase III ATOMIC study, recently published in The New England Journal of Medicine. ATOMIC demonstrated that adding Tecentriq to modified (m)FOLFOX6 chemotherapy reduced the risk of disease recurrence or death by
Colon cancer remains one of the world's most common and deadliest tumours.4 Over one million people are diagnosed globally each year, and nearly
Roche is pursuing further regulatory filings for Tecentriq, including with the European Medicines Agency, to bring this immunotherapy-based adjuvant option to patients with dMMR colon cancer worldwide as soon as possible.
About the ATOMIC study
ATOMIC (A021502, NCT02912559) is a phase III, randomised, open-label, multicentre study investigating the addition of Tecentriq® (atezolizumab) to modified (m)FOLFOX6 chemotherapy (a combination of folinic acid, fluorouracil, and oxaliplatin) in patients with stage III colon cancer who have a deficiency in DNA mismatch repair (dMMR). The trial enrolled 712 patients. Participants were randomised 1:1 to receive either mFOLFOX6 plus Tecentriq for 12 cycles (six months) followed by Tecentriq monotherapy for 13 cycles (an additional six months), or mFOLFOX6 alone for 12 cycles. The primary endpoint is disease-free survival (DFS).
The global study in the US was sponsored by the US National Cancer Institute (NCI), part of the National Institutes of Health, and led by the Alliance for Clinical Trials in Oncology (Alliance) with participation from other NCI-funded National Clinical Trials Network (NCTN) groups. Genentech, a member of the Roche Group, provided support for the study through a Cooperative Research and Development Agreement between NCI and Genentech. The trial was led globally by Frank A. Sinicrope, MD, Professor of Oncology at the Mayo Clinic and US Principal Investigator within the Alliance. German participation in this major international academic collaboration was enabled through close cooperation between the Alliance and the AIO-Studien-gGmbH, in partnership with the AIO (Arbeitsgemeinschaft Internistische Onkologie) of the German Cancer Society (Deutsche Krebsgesellschaft, DKG), under the national leadership of Prof. Dr. Anke Reinacher-Schick (Ruhr-Universität Bochum). AIO-affiliated study sites enrolled patients during the later recruitment phase, ensuring access for eligible patients in Germany.
About Tecentriq® (atezolizumab)
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.
About Roche in oncology
For over 60 years, Roche has delivered transformative medicines and diagnostics, redefining the treatment of some of the most challenging cancers. Driven by a vision of a future where cancer can be cured, we focus our efforts on cancers with the highest societal impact and where we bring deep expertise, including breast, lung, and blood cancers, while pursuing breakthrough innovation in other areas of unmet need. Our pipeline features a diverse array of modalities, from small molecules and antibodies to next-generation ADCs and allogeneic CAR T-cell therapies. By advancing best-in-class precision medicine, pioneering novel combinations, and leveraging key technologies and partnerships, Roche tackles oncology's toughest challenges with the goal of delivering life-changing outcomes for people with cancer.
About Roche
Roche (SIX: RO, ROP; OTCQX: RHHBY) is a healthcare company uniquely placed to prevent, stop and cure diseases by uniting leading science and technology across diagnostics, medicines and digital solutions.
Roche was founded in Basel, Switzerland in 1896 and today is a leading provider of transformative medicines and diagnostics for millions of people in over 150 countries around the world. It is dedicated to tackling healthcare challenges that place the greatest strain on patients, families, communities and healthcare systems. Across its Diagnostics and Pharmaceutical divisions, Roche focuses on areas including oncology, neurology, cardiovascular and metabolic diseases, ophthalmology, infectious diseases and immunology with the aim of providing real and positive change for patients, the people they love and the professionals who care for them.
Genentech in the United States is a fully owned subsidiary in the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, a major innovator in the Japanese therapeutic antibody market.
For more information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by law.
References
[1] Sinicrope F, et al. Atezolizumab plus FOLFOX for Stage III Mismatch Repair–Deficient Colon Cancer. N Engl J Med. 2026;394:1155-1166.
[2] Gonzalez B, et al. Analyzing recurrence in colorectal cancer: Is a five years follow-up enough? Annals of Oncology. 2024;35(1);11.
[3] Nors J et al. Incidence of Recurrence and Time to Recurrence in Stage I to III Colorectal Cancer: A Nationwide Danish Cohort Study. JAMA Oncology. 2024;10(1):54–62.
[4] World Health Organization. Cancer [Internet; cited 2026 October]. Available from: https://www.who.int/news-room/fact-sheets/detail/cancer.
[5] Boland CR, et al. Microsatellite Instability in Colorectal Cancer. Gastroenterology. 2010;138:2073–2087.
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Attachment
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did the FDA approve for Roche’s Tecentriq in stage III colon cancer?
The FDA approved Tecentriq and Tecentriq Hybreza with a fluoropyrimidine and oxaliplatin as treatment after surgery for stage III colon cancer deficient in DNA mismatch repair (dMMR). The approval marks Tecentriq’s twelfth US indication.
How was Tecentriq given in Roche’s ATOMIC colon cancer trial?
Patients in the combination group received 12 cycles of modified FOLFOX6 plus Tecentriq over six months, followed by 13 cycles of Tecentriq alone over an additional six months. The comparison group received modified FOLFOX6 alone for 12 cycles. Patients were randomly assigned 1:1, and the primary measure was disease-free survival.
How was dMMR status determined in the ATOMIC study supporting Roche’s Tecentriq approval?
DNA mismatch repair deficiency was determined using an immunohistochemistry test, such as the VENTANA MMR RxDx Panel. The reported benefit applied to people with stage III dMMR colon cancer.