IMbrave050 Phase III Trial Meets Primary Endpoint: Adjuvant 'T+A' Therapy Significantly Reduces Recurrence Risk in High-Risk Early-Stage Hepatocellular Carcinoma

2023Year1Month19Roche Pharmaceuticals announced that in a pre-specified interim analysis, adjuvant treatment for liver cancerIIIPhase ResearchIMbrave050Reached the primary endpoint——Relapse-Free Survival (RFS）。IMbrave050The study aims to evaluatePD-L1The immunosuppressant Atezolizumab (trade name: Tecentriq)®，Tecentriq®) in combination with Bevacizumab (trade name: Avastin®，Avastin®Hereinafter referred to as“‘T+A’Therapy”) as postoperative adjuvant therapy, the efficacy for early-stage hepatocellular carcinoma patients with a high risk of disease recurrence. Compared with active monitoring,“T+A”In the intention-to-treat population of liver cancer patients with an increased risk of recurrence after curative resection or ablation, there was a statistically significant improvement in recurrence-free survival.

Overall Survival (OS) The data were not yet mature at the time of the interim analysis, and subsequent research will continue with further analyses to follow. The safety profile of the combination therapy of atezolizumab and bevacizumab is consistent with the known safety profiles of each drug when used individually and with the underlying disease. Roche will present the results at an upcoming international medical conference.IMbrave050Research data.

Chief Medical Officer and Head of Global Product Development at RocheLevi GarrawayDr. stated:“Currently, more than70%Postoperative recurrence may occur, affecting prognosis and survival.IMbrave050The study is the first to confirm that the use of tumor immunotherapy combined with other therapies can reduce the risk of recurrence in patients with this type of hepatocellular carcinoma.IIIPhase clinical trial. We are very pleased to see that this combination therapy has the potential to bring clinical benefits to patients with early-stage liver cancer, and we are also looking forward to further validating these benefits through more mature data analysis.”

Primary liver cancer is the leading cause of death in China.4Common malignant tumors and the2The leading cause of cancer-related deaths, with new cases of liver cancer accounting for approximately global45.3%, accounting for approximately global47.1%, people's lives and health are severely threatened by liver cancer. Radical treatments such as surgical resection and radiofrequency ablation are the primary means for liver cancer patients to achieve long-term survival, but the persistently high postoperative recurrence rate is a major challenge in China’s clinical treatment of liver cancer. Liver cancer patients who undergo radical surgical resection experience...5Annual recurrence rate reached40%-60%，5The survival rate is only50%-60%For postoperative liver cancer patients, there is a significant unmet clinical need for the prevention and reduction of recurrence.

“About China77%Liver cancer originating from hepatitis B virus infection is characterized by underlying liver disease, insidious onset, atypical symptoms, and poor prognosis. The majority of patients are initially diagnosed at an advanced stage, losing the opportunity for surgery or other local treatments; even if surgery or other local treatments are possible, recurrence and metastasis are common. Therefore, there is an urgent need for adjuvant therapy that can reduce the recurrence rate after radical treatment to improve patient outcomes.”IMbrave050Co-Chair of the Global Steering Committee, Chinese Society of Clinical Oncology (CSCO）Vice Chairman, Professor Shukui Qin, Director of the Oncology Center at Jinling Hospital, pointed out,“IMbrave150The success of the study has ushered in a new era of immunotherapy for advanced liver cancer, significantly reducing the risk of death for patients with unresectable hepatocellular carcinoma and markedly improving their quality of life. Today,IMbrave050Research once again brings good news, showing remarkable performance in patients at high risk of recurrence after radical treatment. This is another breakthrough in the field of liver cancer treatment, which will create greater possibilities for the long-term high-quality survival of liver cancer patients. Congratulations!”

IMbrave050Professor Jian Zhou, the leading researcher in China, Vice President of Zhongshan Hospital Affiliated to Fudan University, and Director of the Hepatic Surgery Department, stated:“Hepatocellular carcinoma is one of the most common types of malignant tumors in the digestive system. Its biological characteristics determine a persistently high rate of metastasis and recurrence even after curative resection, leading to poor prognosis for patients. The liver's immune tolerance results in relatively lower immune capacity compared to other organs, and the immunity of hepatocellular carcinoma patients often significantly declines post-surgery. This immunosuppressive state is more likely to accelerate tumor progression. As the world’s first large-scaleIIIPhase Clinical Study,IMbrave050The study demonstratedPD-L1/VEGFInhibitors can enhance the anti-tumor immune response after surgical resection or ablation, validating the theoretical mechanism of using combination immunotherapy to prevent recurrence.‘T+A’The therapy is expected to fill the gap in the current field of adjuvant treatment for liver cancer drugs, providingHCCMore treatment options for patients at high risk of postoperative recurrence.”

Roche's Tecentriq®(Atezolizumab) has established an extensive development plan, which includes multiple ongoing and plannedIII-phase studies, covering lung cancer, genitourinary tumors, skin cancer, breast cancer, digestive system tumors, gynecological tumors, and head and neck cancer, including those aimed at evaluating Tecentriq.®Research on monotherapy and combination immunotherapy with other drugs in various fields such as metastatic tumors, adjuvant therapy, and neoadjuvant therapy.

References

1， Hack SP, Spahn J, Chen M et al. IMbrave 050: a Phase III trial of atezolizumab plus bevacizumab in high-risk hepatocellular carcinoma after curative resection or ablation. Future Oncology. 2020 May;16(15):975-989.

2， National Health Commission of China "Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022Year Edition)》

3， CSCO Guidelines for the Diagnosis and Treatment of Primary Liver Cancer (2022）

4， Lim K C, Chow P K H, Allen J C, et al. Systematic review of outcomes of liver resection for early hepatocellular carcinoma within the Milan criteria[J]. Journal of British Surgery, 2012, 99(12): 1622-1629.