F. Hoffmann-La Roche Ltd: Roche's Tecentriq plus Avastin reduced the risk of cancer returning in people with certain types of adjuvant liver cancer in a Phase III study

• In the first-ever positive Phase III trial in the adjuvant hepatocellular carcinoma (HCC) setting, Tecentriq plus Avastin reduced the risk of disease recurrence by 28%¹
• Up to 80% of people with this type of HCC experience disease recurrence, at which point they are faced with poorer prognosis and shorter survival²
• These data will be presented at the American Association for Cancer Research (AACR) Annual Meeting 2023 and included in the official press programme
  
  

Basel, 16 April 2023 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today new data from the Phase III IMbrave050 study that show Tecentriq® (atezolizumab) plus Avastin® (bevacizumab) demonstrated a statistically significant improvement in recurrence-free survival (RFS) in people with hepatocellular carcinoma (HCC) at high risk of disease recurrence following liver resection or ablation with curative intent.²

"Four out of five people with HCC who receive surgery with curative intent may still see their cancer return. Thus, an urgent need exists for adjuvant treatments to prevent early recurrence and improve survival rates," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "With Tecentriq plus Avastin already a standard of care in unresectable HCC, we are pleased with the potential of these results and look forward to seeing more mature data."

The Tecentriq investigational combination reduced the risk of cancer returning by 28%, compared with active surveillance, at a median follow-up of 17.4 months (independent review facility [IRF]-RFS hazard ratio [HR]=0.72, 95% CI: 0.56-0.93; P=0.0120).¹ The IRF-RFS findings were generally consistent across clinical subgroups. Overall Survival (OS), a key secondary endpoint, was immature (7% event-rate) at the time of data analysis. The safety data for Tecentriq plus Avastin were consistent with the well-established safety profile of each therapeutic treatment and with the underlying disease.¹

The late-breaking data will be presented at the AACR Annual Meeting 2023 and have been included as part of the official press programme. Discussions with health authorities are ongoing and follow-up will continue for the final RFS data and more mature OS data at the next planned analysis.

The IMbrave050 study is part of Roche's overall commitment to drive fundamental treatment change and improve outcomes for people living with liver cancer. Tecentriq plus Avastin was the first treatment in over a decade to significantly improve OS over the existing standard of care, based on data from the IMbrave150 study.³ The Tecentriq combination quickly became a standard of care in unresectable HCC and is clearly defined as a preferred front-line treatment in multiple international clinical guidelines.

About the IMbrave050 study
IMbrave050 is a Phase III global, multicentre, open-label, randomised study evaluating the efficacy and safety of adjuvant Tecentriq plus Avastin, compared with active surveillance, in people with HCC at high risk of recurrence (determined by the size and number of cancerous lesions and the histopathology results, if available) after surgical resection or ablation with curative intent.

The study randomised 668 people with a ratio of 1:1 to receive either Tecentriq (1,200 mg every three weeks) plus Avastin (15 mg/kg every three weeks) for a period of 12 months or 17 cycles, or no intervention with active surveillance. The primary endpoint is independent review facility-assessed RFS. Key secondary endpoints include OS, RFS as determined by the investigator and RFS in patients with PD-L1-positive disease.

About hepatocellular carcinoma
Liver cancer is the third leading cause of cancer death and one of the few cancers where mortality is rising.^4,5 More than 900,000 people are diagnosed with the disease globally each year, which translates to one person diagnosed every 90 seconds.⁴ Nine out of ten cases of HCC are caused by chronic liver disease, which includes chronic hepatitis B and C infection, non-alcoholic fatty liver disease (NAFLD), non-alcoholic steatohepatitis (NASH), alcohol-related liver disease (ALD) and cirrhosis resulting from these conditions.^5,6

If diagnosed in the early stage, surgery may be prescribed to remove the primary tumour, however an estimated 70-80% of people with early-stage HCC experience disease recurrence following surgery.² Early recurrence is associated with poorer prognosis and shorter survival.^2,7 Tumour size, number of tumours, and portal vein invasion are associated with an increased risk of recurrence.⁷

About Tecentriq
Tecentriq is a cancer immunotherapy approved for some of the most aggressive and difficult-to-treat forms of cancer. Tecentriq was the first cancer immunotherapy approved for the treatment of a certain type of early-stage non-small cell lung cancer (NSCLC), small cell lung cancer (SCLC) and 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, PD-L1-positive metastatic triple-negative breast cancer and BRAF V600 mutation-positive advanced melanoma.

Tecentriq is a monoclonal antibody designed to bind with a protein called programmed death ligand-1 (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 activation of T-cells. Tecentriq is a cancer immunotherapy that has the potential to be used as a foundational combination partner with other immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. In addition to intravenous infusion, the formulation of Tecentriq is also being investigated as a subcutaneous injection to help address the growing burden of cancer treatment for patients and healthcare systems.

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.

In recognising our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.

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.

All trademarks used or mentioned in this release are protected by law.

References
[1] Chow P, Chen M, Cheng AL, et al. IMbrave050: Phase 3 study of adjuvant atezolizumab + bevacizumab versus active surveillance in patients with hepatocellular carcinoma. Last accessed: March 2023.
[5] Llovet JM, Kelley RK, Villanueva A, et al. Hepatocellular carcinoma. Nature Reviews Disease Primers. 2021;7(1):6.
[6] McGlynn KA, Petrick JL & El-Serag HB. Epidemiology of Hepatocellular Carcinoma. Hepatology. 2021;73:4-13.
[7] Saito A, Toyoda H, Kobayashi M, et al. Prediction of early recurrence of hepatocellular carcinoma after resection using digital pathology images assessed by machine learning. Modern Pathology. 2021. 34:417-425.

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