IMbrave150: Updated overall survival (OS) data from a global, randomized, open-label phase III study of atezolizumab (atezo) + bevacizumab (bev) versus sorafenib (sor) in patients (pts) with unresectable hepatocellular carcinoma (HCC).

American Society of Clinical Oncology (ASCO) - Tập 39 Số 3_suppl - Trang 267-267 - 2021
Richard S. Finn1, Shukui Qin2, Masafumi Ikeda3, Peter R. Galle4, Michel Ducreux5, Tae‐You Kim6, Ho Yeong Lim7, Masatoshi Kudo8, В. В. Бредер9, Philippe Merle10, Ahmed O. Kaseb11, Daneng Li12, Wendy Verret13, Hui Shao14, Juan Liu14, Lindong Li14, Andrew X. Zhu15, Ann‐Lii Cheng16
1Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles, CA;
2People's Liberation Army Cancer Center, Nanjing, China;
3National Cancer Center Hospital East, Kashiwa, Japan
4University Medical Center Mainz, Mainz, Germany
5Gustave Roussy Cancer Center, Villejuif, France
6Seoul National University College of Medicine, Seoul, South Korea
7Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea
8Kindai University, Faculty of Medicine, Osaka, Japan
9N.N. Blokhin Russian Cancer Research Center, Moscow, Russian Federation
10University Hospital La Croix-Rousse, Lyon, France;
11The University of Texas MD Anderson Cancer Center, Houston, TX
12City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte, CA
13Genentech Inc., South San Francisco, CA
14Roche Product Development, Shanghai, China;
15Harvard Medical School, Massachusetts General Hospital Cancer Center, Boston, MA;
16National Taiwan University Cancer Center and National Taiwan University Hospital, Taipei, Taiwan;

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267 Background: Atezo + bev has been approved globally for pts with unresectable HCC who have not received prior systemic therapy, based on results from IMbrave150 (NCT03434379). At a median of 8.6 mo follow-up, both coprimary endpoints were met, with statistically significant and clinically meaningful improvements observed with atezo + bev vs sor for OS (HR, 0.58 [95% CI, 0.42, 0.79]; P<0.001) and independently-assessed progression-free survival (PFS; per RECIST 1.1; HR, 0.59 [95% CI, 0.47, 0.76]; P<0.001) (Finn, et al. N Engl J Med 2020). Here, we report an updated OS analysis for IMbrave150. Methods: The global, multicenter, randomized, open-label, Phase III study IMbrave150 enrolled 501 systemic treatment–naive pts with unresectable HCC, ≥1 measurable untreated lesion (RECIST 1.1), Child-Pugh class A liver function and ECOG PS 0/1. Pts were randomized 2:1 to receive either atezo 1200 mg IV q3w + bev 15 mg/kg IV q3w or sor 400 mg bid until unacceptable toxicity or loss of clinical benefit per investigator. This post hoc, descriptive OS analysis was conducted with 12 mo of additional follow up from the primary analysis. Results: 501 pts were enrolled, including 336 to atezo + bev and 165 to sor. At the clinical cut-off date of Aug 31, 2020, median follow-up was 15.6 mo and 280 OS events were observed. Median OS was 19.2 mo with atezo + bev vs 13.4 mo with sor (HR, 0.66 [95% CI, 0.52, 0.85]; P=0.0009). Survival at 18 mo was 52% with atezo + bev and 40% with sor. Survival benefit with atezo + bev over sor was generally consistent across subgroups and with the primary analysis. The updated objective response rate (ORR; 29.8% per RECIST 1.1) with atezo + bev was in line with the primary analysis, with more pts achieving complete response (CR; 7.7%) than previously reported. Additional response data are in Table. Safety was aligned with the primary analysis, with no new signals identified. Conclusions: IMbrave150 showed consistent clinically meaningful treatment benefit and safety with 12 mo of additional follow-up. The combination provides the longest survival seen in a front-line Phase III study in advanced HCC, confirming atezo + bev as a standard of care for previously untreated, unresectable HCC. Clinical trial information: NCT03434379. [Table: see text]

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American Society of Clinical Oncology (ASCO)

Tập 39 Số 3_suppl

267-267

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