Complete responses (CR) in patients receiving atezolizumab (atezo) + bevacizumab (bev) versus sorafenib (sor) in IMbrave150: A phase III clinical trial for unresectable hepatocellular carcinoma (HCC).

Authors

null

Richard S. Finn

Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles, CA

Richard S. Finn , Shukui Qin , Masafumi Ikeda , Peter R. Galle , Michel Ducreux , Tae-You Kim , Masatoshi Kudo , Ho Yeong Lim , Valeriy Vladimirovich Breder , Philippe Merle , Ahmed Omar Kaseb , Daneng Li , Yin-Hsun Feng , Wendy Verret , Derek-Zhen Xu , Sairy Hernandez , Beiying Ding , Andrew X. Zhu , Ann-Lii Cheng

Organizations

Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles, CA, People's Liberation Army Cancer Center, Jinling Hospital, Nanjing, China, National Cancer Center Hospital East, Kashiwa, Japan, University Medical Center, Mainz, Germany, Gustave Roussy Cancer Campus Grand Paris, Villejuif, France, Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, South Korea, Department of Gastroenterology and Hepatology, Kindai University Faculty of Medicine, Osaka, Japan, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea, Russian Oncological Research Center, N.N. Blokhin of Ministry of Health, Moscow, Russian Federation, Hospital La Croix-Rousse, Lyon, France, GI Medical Oncology Department, The University of Texas MD Anderson Cancer Center, Houston, TX, Department of Medical Oncology, City of Hope Comprehensive Cancer Center and Beckman Research Institute, Duarte, CA, Division of Hematology and Oncology, Department of Internal Medicine, Chi-Mei Medical Center, Tainan, Taiwan, Genentech, Inc., South San Francisco, CA, Roche Product Development, Shanghai, China, Harvard Medical School, Massachusetts General Hospital, Boston, MA, National Taiwan University Hospital and National Taiwan University Cancer Center, Taipei, Taiwan

Research Funding

Pharmaceutical/Biotech Company
F. Hoffmann-La Roche, Ltd.

Background: In the Phase III IMbrave150 trial, statistically significant and clinically meaningful improvements in OS and PFS were seen with atezo + bev vs sor in pts with unresectable HCC who had not received prior systemic therapy (Cheng, ESMO Asia, 2019). Historically, CR rates have been low in HCC clinical trials. Here we report the baseline characteristics for IMbrave150 pts with a CR. Methods: IMbrave150 enrolled systemic treatment-naive pts with unresectable HCC. 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. Co-primary endpoints were OS and PFS by independent review facility (IRF)–assessed RECIST 1.1. The key secondary endpoints IRF ORR per RECIST 1.1 and IRF ORR per HCC mRECIST were also part of the study statistical testing hierarchy. Results: The ITT population included 336 pts randomized to atezo + bev and 165 pts randomized to sor. With a median follow-up of 8.6 mo (data cutoff, Aug 29, 2019), OS HR was 0.58 (95% CI: 0.42, 0.79; P = 0.0006) and PFS HR was 0.59 (95% CI: 0.47, 0.76; P< 0.0001) with atezo + bev vs sor. ORR was 27% vs 12% (P< 0.0001) per IRF RECIST 1.1 and 33% vs 13% (P< 0.0001) per IRF HCC mRECIST with atezo + bev vs sor, respectively. For responders (per IRF RECIST 1.1), median time to response was 2.8 mo (range, 1.2-11.3) with atezo + bev and 3.3 mo (range, 1.2-7.2) with sor. CR per IRF-assessed RECIST 1.1 was achieved by 18 pts in the atezo + bev arm and 0 pts in the sor arm. The baseline characteristics for atezo + bev CR pts are shown in the table. Additional characteristics will be shown. Conclusions: IMbrave150 demonstrated statistically significant and clinically meaningful improvement in both OS and PFS with atezo + bev vs sor in pts with unresectable HCC who have not received prior systemic therapy. Pts achieved CRs regardless of poor prognostic factors or etiology. Atezo + bev may be a practice-changing treatment for pts with unresectable HCC. Clinical trial information: NCT03434379.

n (%)CR pts; atezo + bev
(n = 18)
All pts; atezo + bev
(n = 336)
≥ 65 y7 (39)161 (48)
Asia excluding Japan | Rest of world8 (44) | 10 (56)133 (40) | 203 (60)
ECOG PS 15 (28)127 (38)
Etiology, HBV | HCV | non-viral9 (50) | 5 (28) | 4 (22)164 (49) | 72 (21) | 100 (30)
Child-Pugh class, A5 | A612 (67) | 6 (33)239 (72) | 94 (28)
(n = 334)
BCLC stage, A | B | C1 (6) | 4 (22) | 13 (72)8 (2) | 52 (16) | 276 (82)
MVI | EHS | MVI and/or EHS6 (33) | 10 (56) | 12 (67)129 (38) | 212 (63) | 258 (77)
AFP ≥ 400 ng/mL3 (17)126 (38)
Prior local therapy12 (67)161 (48)

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Abstract Details

Meeting

2020 ASCO Virtual Scientific Program

Session Type

Poster Session

Session Title

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Track

Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary

Sub Track

Hepatobiliary Cancer

Clinical Trial Registration Number

NCT03434379

Citation

J Clin Oncol 38: 2020 (suppl; abstr 4596)

DOI

10.1200/JCO.2020.38.15_suppl.4596

Abstract #

4596

Poster Bd #

204

Abstract Disclosures