Shukui Qin1, Zhenggang Ren2, Yin-Hsun Feng3, Thomas Yau4, Baocheng Wang5, Haitao Zhao6, Yuxian Bai7, Shanzhi Gu8, Lindong Li9, Sairy Hernandez10, Derek-Zhen Xu9, Sohail Mulla11, Yifan Wang9, Hui Shao9, Ann Lii Cheng12. 1. People's Liberation Army Cancer Center, Jinling Hospital, Nanjing, China. 2. Liver Cancer Institute and Department of Liver Cancer Surgery, Zhongshan Hospital, Fudan University, Shanghai, China. 3. Department of Internal Medicine, Chi Mei Medical Center, Tainan, Taiwan. 4. Department of Medicine, Haematology, Medical Oncology & Bone Marrow Transplantation Division, Queen Mary Hospital, Hong Kong, China. 5. Department of Oncology, General Hospital of Jinan Military Command, Jinan, China. 6. Department of Liver Surgery, Peking Union Medical College Hospital, Beijing, China. 7. Department of Gastrointestinal Oncology, Harbin Medical University Cancer Hospital, Harbin, China. 8. Radioactive Interventional Department, Hunan Cancer Hospital, Changsha, China. 9. Product Development Oncology, Roche (China) Holding Ltd., Shanghai, China. 10. Medical Affairs, Genentech, Inc., South San Francisco, California, USA. 11. Product Development Biometrics, Hoffmann-La Roche Ltd., Mississauga, Ontario, Canada. 12. Department of Medical Oncology, National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan.
Abstract
INTRODUCTION: Atezolizumab plus bevacizumab significantly improved overall survival (OS) and progression-free survival (PFS) versus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in IMbrave150. Efficacy and safety data from the Chinese subpopulation are reported. METHODS: IMbrave150, a global, randomized, open-label, phase 3 study in patients with systemic treatment-naive unresectable HCC, included an extension phase that enrolled additional patients from mainland China. Patients were randomized (2:1) to receive intravenous atezolizumab 1,200 mg plus bevacizumab 15 mg/kg once every 3 weeks or sorafenib 400 mg twice a day until unacceptable toxicity or loss of clinical benefit. Co-primary endpoints were OS and independent review facility-assessed PFS per Response Evaluation Criteria in Solid Tumors version 1.1 in the intention-to-treat population. RESULTS: Of 194 Chinese patients enrolled from April 16, 2018, to April 8, 2019 (137 in the global study and 57 in the China extension phase), 133 received atezolizumab plus bevacizumab and 61 received sorafenib. At the data cutoff (August 29, 2019), the stratified hazard ratio for OS was 0.44 (95% CI, 0.25-0.76) and for PFS was 0.60 (95% CI, 0.40-0.90). The respective median OS and PFS with atezolizumab plus bevacizumab were not reached (NR; 95% CI, 13.5 months to NR) and 5.7 months (95% CI, 4.2-8.3) versus 11.4 months (95% CI, 6.7 to NR) and 3.2 months (95% CI, 2.6-4.8) with sorafenib. Grade 3-4 adverse events (AEs) occurred in 78 of 132 (59.1%) atezolizumab plus bevacizumab-treated and 27 of 58 (46.6%) sorafenib-treated patients. The most common grade 3-4 AE with atezolizumab plus bevacizumab was hypertension, occurring in 15.2% of patients; however, other high-grade AEs were infrequent. CONCLUSION: Clinically meaningful improvements in OS and PFS observed with atezolizumab plus bevacizumab versus sorafenib suggest that atezolizumab plus bevacizumab may become a practice-changing treatment for Chinese patients with unresectable HCC.
INTRODUCTION: Atezolizumab plus bevacizumab significantly improved overall survival (OS) and progression-free survival (PFS) versus sorafenib in patients with unresectable hepatocellular carcinoma (HCC) in IMbrave150. Efficacy and safety data from the Chinese subpopulation are reported. METHODS: IMbrave150, a global, randomized, open-label, phase 3 study in patients with systemic treatment-naive unresectable HCC, included an extension phase that enrolled additional patients from mainland China. Patients were randomized (2:1) to receive intravenous atezolizumab 1,200 mg plus bevacizumab 15 mg/kg once every 3 weeks or sorafenib 400 mg twice a day until unacceptable toxicity or loss of clinical benefit. Co-primary endpoints were OS and independent review facility-assessed PFS per Response Evaluation Criteria in Solid Tumors version 1.1 in the intention-to-treat population. RESULTS: Of 194 Chinese patients enrolled from April 16, 2018, to April 8, 2019 (137 in the global study and 57 in the China extension phase), 133 received atezolizumab plus bevacizumab and 61 received sorafenib. At the data cutoff (August 29, 2019), the stratified hazard ratio for OS was 0.44 (95% CI, 0.25-0.76) and for PFS was 0.60 (95% CI, 0.40-0.90). The respective median OS and PFS with atezolizumab plus bevacizumab were not reached (NR; 95% CI, 13.5 months to NR) and 5.7 months (95% CI, 4.2-8.3) versus 11.4 months (95% CI, 6.7 to NR) and 3.2 months (95% CI, 2.6-4.8) with sorafenib. Grade 3-4 adverse events (AEs) occurred in 78 of 132 (59.1%) atezolizumab plus bevacizumab-treated and 27 of 58 (46.6%) sorafenib-treated patients. The most common grade 3-4 AE with atezolizumab plus bevacizumab was hypertension, occurring in 15.2% of patients; however, other high-grade AEs were infrequent. CONCLUSION: Clinically meaningful improvements in OS and PFS observed with atezolizumab plus bevacizumab versus sorafenib suggest that atezolizumab plus bevacizumab may become a practice-changing treatment for Chinese patients with unresectable HCC.
Authors: Al B Benson; Thomas A Abrams; Edgar Ben-Josef; P Mark Bloomston; Jean F Botha; Bryan M Clary; Anne Covey; Steven A Curley; Michael I D'Angelica; Rene Davila; William D Ensminger; John F Gibbs; Daniel Laheru; Mokenge P Malafa; Jorge Marrero; Steven G Meranze; Sean J Mulvihill; James O Park; James A Posey; Jasgit Sachdev; Riad Salem; Elin R Sigurdson; Constantinos Sofocleous; Jean-Nicolas Vauthey; Alan P Venook; Laura Williams Goff; Yun Yen; Andrew X Zhu Journal: J Natl Compr Canc Netw Date: 2009-04 Impact factor: 11.908
Authors: Maen Abdelrahim; Abdullah Esmail; Ashish Saharia; Ala Abudayyeh; Noha Abdel-Wahab; Adi Diab; Naoka Murakami; Ahmed O Kaseb; Jenny C Chang; Ahmed Osama Gaber; Rafik Mark Ghobrial Journal: Cancers (Basel) Date: 2022-03-30 Impact factor: 6.575