Roche’s Tecentriq showed significant overall and disease-free survival benefits in bladder cancer with ctDNA-guided treatment
Roche (OTCQX: RHHBY) reported positive phase III IMvigor011 results for Tecentriq (atezolizumab) as adjuvant therapy in muscle-invasive bladder cancer using a ctDNA-guided approach.
At median follow-up 16.1 months, Tecentriq reduced risk of death by 41% (OS HR=0.59; 95% CI 0.39–0.90; median OS 32.8 vs 21.1 months) and risk of recurrence or death by 36% (DFS HR=0.64; 95% CI 0.47–0.87; median DFS 9.9 vs 4.8 months) versus placebo. The trial used Signatera ctDNA MRD testing to select patients and reported a safety profile consistent with prior studies. Results presented at ESMO Congress 2025 and will be discussed with health authorities including the FDA.
Roche (OTCQX: RHHBY) ha riportato risultati positivi di fase III IMvigor011 per Tecentriq (atezolizumab) come terapia adiuvante nel cancro della vescica muscolo-invasivo utilizzando un approccio guidato da ctDNA.
Con un follow-up mediano di 16,1 mesi, Tecentriq ha ridotto il rischio di morte del 41% (OS HR=0,59; 95% CI 0,39–0,90; mediana OS 32,8 vs 21,1 mesi) e il rischio di recidiva o morte del 36% (DFS HR=0,64; 95% CI 0,47–0,87; mediana DFS 9,9 vs 4,8 mesi) rispetto al placebo. Lo studio ha utilizzato i test Signatera ctDNA MRD per selezionare i pazienti e ha riportato un profilo di sicurezza conforme agli studi precedenti. I risultati sono stati presentati al Congresso ESMO 2025 e saranno discussi con le autorità sanitarie, incluso la FDA.
Roche (OTCQX: RHHBY) informó resultados positivos de fase III IMvigor011 para Tecentriq (atezolizumab) como terapia adyuvante en el cáncer de vejiga musculoinvasivo utilizando un enfoque guiado por ctDNA.
A la mediana de seguimiento de 16,1 meses, Tecentriq redujo el riesgo de muerte en 41% (OS HR=0.59; 95% CI 0.39–0.90; supervivencia mediana 32.8 vs 21.1 meses) y el riesgo de recurrencia o muerte en 36% (DFS HR=0.64; 95% CI 0.47–0.87; DFS mediana 9.9 vs 4.8 meses) frente al placebo. El ensayo utilizó pruebas Signatera ctDNA MRD para seleccionar a los pacientes y reportó un perfil de seguridad consistente con estudios anteriores. Los resultados se presentaron en el Congreso ESMO 2025 y se discutirán con las autoridades sanitarias, incluida la FDA.
로슈(RHHBY 쿼크X)는 CT DNA 기반 접근법을 이용한 근육침투성 방광암의 보조요법으로 Tecentriq(atezolizumab)에 대한 3상 IMvigor011의 긍정적 결과를 보고했습니다.
중앙치명추적 16.1개월의 중위 추적 기간에서 Tecentriq은 사망 위험을 41% 감소시켰고(OS HR=0.59; 95% CI 0.39–0.90; 중위 OS 32.8 vs 21.1개월), 재발 또는 사망 위험을 36% 감소시켰습니다(DFS HR=0.64; 95% CI 0.47–0.87; 중위 DFS 9.9 vs 4.8개월) 위약 대비. 이 연구는 Signatera ctDNA MRD 테스트를 사용해 환자를 선별했고 이전 연구와 일치하는 안전성 프로필을 보고했습니다. 결과는 ESMO Congress 2025에서 발표되었으며 FDA를 포함한 보건당국과 논의될 예정입니다.
Roche (OTCQX: RHHBY) a annoncé des résultats positifs de phase III IMvigor011 pour Tecentriq (atezolizumab) en tant que thérapie adjuvante dans le cancer de la vessie musculo-invasif en utilisant une approche guidée par ctDNA.
À un suivi médian de 16,1 mois, Tecentriq a réduit le risque de décès de 41% (OS HR=0,59; IC à 95% 0,39–0,90; médiane de survie globale 32,8 vs 21,1 mois) et le risque de rechute ou de décès de 36% (DFS HR=0,64; IC à 95% 0,47–0,87; médiane de DFS 9,9 vs 4,8 mois) par rapport au placebo. L essai a utilisé les tests Signatera ctDNA MRD pour sélectionner les patients et a rapporté un profil de sécurité conforme aux études antérieures. Les résultats ont été présentés au Congrès ESMO 2025 et seront discutés avec les autorités sanitaires, y compris la FDA.
Roche (OTCQX: RHHBY) meldete positive Phase-III-Ergebnisse von IMvigor011 für Tecentriq (Atezolizumab) als adjuvante Therapie beim muskelinvasiven Blasenkarzinom unter Einsatz eines ctDNA-gesteuerten Ansatzes.
Bei einer Nachbeobachtungsmedian von 16,1 Monaten senkte Tecentriq das Sterberisiko um 41% (OS HR=0,59; 95% KI 0,39–0,90; medianes OS 32,8 vs 21,1 Monate) und das Risiko eines Rezidivs oder Todes um 36% (DFS HR=0,64; 95% KI 0,47–0,87; medianes DFS 9,9 vs 4,8 Monate) gegenüber Placebo. Die Studie nutzte Signatera ctDNA MRD-Tests zur Patientenauswahl und berichtete ein Sicherheitsprofil, das mit früheren Studien konsistent ist. Die Ergebnisse wurden auf dem ESMO-Kongress 2025 vorgestellt und werden mit Gesundheitsbehörden, einschließlich der FDA, diskutiert.
روش (OTCQX: RHHBY) أبلغت عن نتائج إيجابية من المرحلة الثالثة IMvigor011 لـ Tecentriq (atezolizumab) كعلاج مساعد في سرطان المثانة العضلي يغسل باستخدام نهج ctDNA الموجه.
تحت متابعة وسيطة 16.1 أشهر، خفض Tecentriq مخاطر الوفاة بنسبة 41% (OS HR=0.59؛ فاصل ثقة 95% 0.39–0.90؛ البقاء على قيد الحياة الوسطي 32.8 مقابل 21.1 شهر) وخطر العودة أو الوفاة بنسبة 36% (DFS HR=0.64؛ فاصل ثقة 95% 0.47–0.87؛ DFS الوسطي 9.9 مقابل 4.8 أشهر) مقارنة بالدواء الوهمي. استخدم التجربة اختبار Signatera ctDNA MRD لاختيار المرضى وأفادت بملف أمان متسق مع الدراسات السابقة. تم عرض النتائج في مؤتمر ESMO 2025 وسيتم مناقشتها مع السلطات الصحية بما فيها FDA.
罗氏 (OTCQX: RHHBY) 报告了 Tecentriq（阿替珠单抗）作为肌层浸润性膀胱癌辅助治疗的 III 期 IMvigor011 结果积极，采用 ctDNA 引导的方法。
中位随访 16.1 个月时，Tecentriq 将死亡风险降低了 41%（OS HR=0.59；95% CI 0.39–0.90；中位 OS 32.8 vs 21.1 月），以及复发或死亡风险降低 36%（DFS HR=0.64；95% CI 0.47–0.87；中位 DFS 9.9 vs 4.8 月），相较于安慰剂。该试验使用 Signatera ctDNA MRD 测试来筛选患者，安全性特征与先前研究一致。结果在 ESMO 2025 大会公布，亦将与包括 FDA 在内的卫生当局讨论。
- Overall survival improved: OS HR 0.59
- Median OS extended to 32.8 months
- Disease-free survival improved: DFS HR 0.64
- Median DFS increased to 9.9 months
- ctDNA selection spared low-risk patients from treatment
- Median follow-up was 16.1 months, a relatively short observation period
- Tecentriq reduced the risk of death by
41% and the risk of disease recurrence or death by36% compared with placebo1 - IMvigor011 is the first global phase III study to read out pioneering a ctDNA- guided approach to post-surgery treatment in muscle-invasive bladder cancer
- Data being presented as part of the Presidential Symposium at the ESMO Congress 2025
Basel, 20 October 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today positive results from the phase III IMvigor011 study evaluating Tecentriq® (atezolizumab) as an adjuvant treatment for people with muscle-invasive bladder cancer (MIBC) who are at risk of recurrence after surgery (cystectomy) and have detectable circulating tumour DNA (ctDNA). In this ctDNA-guided setting, Tecentriq reduced the risk of death (overall survival, OS) by
These results are being presented as part of the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2025. They will also be discussed with health authorities, including the U.S. Food and Drug Administration (FDA).
“These clinically meaningful results show that Tecentriq helped people with muscle-invasive bladder cancer live longer and without their disease returning,” said Levi Garraway, Roche’s Chief Medical Officer and Head of Global Product Development. “The use of serial ctDNA testing to detect molecular residual disease may also advance bladder cancer treatment by combining a precision diagnostic with cancer immunotherapy.”
“Even after surgery, most people with muscle-invasive bladder cancer will face the physical and emotional toll of further treatment,” said Professor Thomas Powles, lead principal investigator of IMvigor011, Professor of Genitourinary Oncology; Chair of Barts Cancer Centre at St. Bartholomew's Hospital. “These results indicate that with Signatera ctDNA testing, we may be able to identify those at risk of recurrence who could benefit from adjuvant atezolizumab treatment and spare others from unnecessary therapy, paving the way for a more personalised treatment approach.”
At median follow up of 16.1 months, median DFS was 9.9 months in the Tecentriq arm versus 4.8 months in the placebo arm (stratified hazard ratio [HR]=0.64;
More than 150,000 people worldwide are diagnosed with MIBC each year.2,3 It is an aggressive type of cancer, with poor long-term outcomes and high treatment burden.4 Despite this, personalised treatment approaches lag behind other cancer types.5 ctDNA-guided treatment could change this, by helping healthcare professionals tailor treatment more precisely to improve clinical benefit and reduce unnecessary intervention.1
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 SignateraTM 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.
For more information, please visit www.roche.com.
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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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FAQ
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