Roche Announces Landmark IMvigor011 Results Showing Tecentriq Significantly Improves Survival in Muscle-Invasive Bladder Cancer Using ctDNA-Guided Treatment

Roche Announces Landmark IMvigor011 Results Showing Tecentriq Significantly Improves Survival in Muscle-Invasive Bladder Cancer Using ctDNA-Guided Treatment

(IN BRIEF) Roche reported groundbreaking phase III IMvigor011 results showing that Tecentriq (atezolizumab) significantly improved overall and disease-free survival in muscle-invasive bladder cancer using a ctDNA-guided treatment approach. Patients receiving Tecentriq experienced a 41% lower risk of death and a 36% lower risk of recurrence or death versus placebo. The study, which used Natera’s Signatera™ ctDNA test to identify patients with molecular residual disease, marks the first global phase III trial to apply a precision-guided strategy for post-surgical bladder cancer treatment. The findings, presented at ESMO 2025, point to a new era of personalized immunotherapy where ctDNA detection helps tailor treatment to individual patient needs.

(PRESS RELEASE) BASEL, 20-Oct-2025 — /EuropaWire/ — Roche (SIX: RO, ROG; OTCQX: RHHBY) has unveiled positive findings from its phase III IMvigor011 trial, which evaluated Tecentriq® (atezolizumab) as an adjuvant therapy for patients with muscle-invasive bladder cancer (MIBC) who are at high risk of recurrence after surgery and have detectable circulating tumour DNA (ctDNA). In this pioneering ctDNA-guided study, Tecentriq demonstrated a 41% reduction in the risk of death and a 36% reduction in the risk of disease recurrence or death compared to placebo, marking a major advance in the post-surgical management of bladder cancer.

IMvigor011 is the first global phase III trial to adopt a ctDNA-guided strategy in treating muscle-invasive bladder cancer, using Natera’s Signatera™ ctDNA Molecular Residual Disease (MRD) test to identify patients most likely to benefit from immunotherapy while sparing low-risk individuals from unnecessary treatment. The safety profile of Tecentriq remained consistent with prior studies, reinforcing its established tolerability in cancer immunotherapy.

“These are clinically meaningful outcomes showing that Tecentriq can extend survival and delay disease recurrence in patients with muscle-invasive bladder cancer,” said Levi Garraway, MD, PhD, Roche’s Chief Medical Officer and Head of Global Product Development. “The use of serial ctDNA testing represents a powerful advancement, pairing precision diagnostics with immunotherapy to enable a more targeted and effective treatment approach.”

Professor Thomas Powles, lead principal investigator of the IMvigor011 study and Chair of Barts Cancer Centre at St. Bartholomew’s Hospital, emphasized the transformative implications of this approach: “With ctDNA testing, we can better identify which patients are most at risk of recurrence and are likely to benefit from Tecentriq, while avoiding overtreatment for those who are not—bringing us closer to truly personalized care in bladder cancer.”

At a median follow-up of 16.1 months, median disease-free survival (DFS) was 9.9 months for the Tecentriq group compared with 4.8 months for those on placebo (hazard ratio [HR] = 0.64; 95% CI: 0.47–0.87, p = 0.0047). Median overall survival (OS) reached 32.8 months with Tecentriq versus 21.1 months with placebo (HR = 0.59; 95% CI: 0.39–0.90, p = 0.0131). Patients who consistently tested negative for ctDNA showed a low risk of recurrence, highlighting the clinical utility of ctDNA monitoring in guiding treatment decisions.

Bladder cancer remains one of the most challenging malignancies, with more than 150,000 new cases of MIBC diagnosed globally each year. Despite advances in cancer care, personalized post-surgical strategies for bladder cancer have lagged behind other cancer types. The results from IMvigor011—presented at the Presidential Symposium of the European Society for Medical Oncology (ESMO) Congress 2025—suggest that ctDNA-guided therapy could redefine how oncologists manage this aggressive disease. Roche plans to engage with global health authorities, including the U.S. Food and Drug Administration (FDA), to discuss these results and future regulatory pathways.

About the IMvigor011 study
IMvigor011 [NCT04660344] is a global phase III, randomised, placebo-controlled, double-blind study designed to evaluate the efficacy and safety of adjuvant treatment with Tecentriq® (atezolizumab) compared with placebo in participants with muscle-invasive bladder cancer (MIBC) who are circulating tumour DNA (ctDNA)-positive and are at risk of recurrence following cystectomy. IMvigor011 utilised Natera’s Signatera^TM as the clinical trial assay. This personalised ctDNA test for the detection of MRD is currently under review by the FDA for use as a companion diagnostic. 761 people participated in the surveillance phase of IMvigor011 and those with positive Signatera tests (250 people) joined the treatment phase, where they received either Tecentriq or placebo. The primary endpoint is investigator-assessed disease-free survival (DFS). Secondary endpoints include overall survival (OS) and tolerability, amongst others.

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. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage (adjuvant) non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and hepatocellular carcinoma (HCC). Tecentriq is also approved in countries around the world, either alone or in combination with targeted therapies and/or chemotherapies, for various forms of metastatic NSCLC, certain types of metastatic urothelial cancer (mUC), PD-L1-positive metastatic triple-negative breast cancer (TNBC), BRAF V600 mutation-positive advanced melanoma and alveolar soft part sarcoma (ASPS).

About Roche in cancer immunotherapy
To learn more about Roche’s scientific-led approach to cancer immunotherapy, please follow this link: https://www.roche.com/solutions/focus-areas/oncology/cancer-immunotherapy

About Roche
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalised healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.

For over 125 years, sustainability has been an integral part of Roche’s business. As a science-driven company, our greatest contribution to society is developing innovative medicines and diagnostics that help people live healthier lives. Roche is committed to the Science Based Targets initiative and the Sustainable Markets Initiative to achieve net zero by 2045.

Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.

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References
[1] Powles T, et al. IMvigor011: a Phase 3 trial of circulating tumour (ct)DNA-guided adjuvant atezolizumab vs placebo in muscle-invasive bladder cancer. To be presented at: ESMO Congress; 2025 Oct 17-21; Berlin, Germany. Abstract #LBA8.
[2] Global Cancer Observatory. Cancer Today GLOBOCAN 2022 Factsheet – Bladder [Internet; cited 2025 October]. Available from: https://gco.iarc.who.int/media/globocan/factsheets/cancers/30-bladder-fact-sheet.pdf.
[3] Ghandour R, et al. Treatment Options and Outcomes in Nonmetastatic Muscle Invasive Bladder Cancer. Trends Cancer. 2019;5(7):426-39.
[4] Vogl U, et al. Current advances in the perioperative treatment of muscle-invasive bladder cancer. Healthbook TIMES Oncol. Hematol. 2025;24(2):54-63.
[5] Van Hoogstraten LMC, et al. Global trends in the epidemiology of bladder cancer challenges for public health and clinical practice. Nat Rev Clin Oncol. 2023;20:287-304.

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SOURCE: Roche