Z Gastroenterol 2021; 59(08): e253
DOI: 10.1055/s-0041-1733733
HCC und CCC
Freitag, 17. September 2021, 15:00-16:20 Uhr, Saal 4
Gastroenterologische Onkologie

IMbrave150: updated efficacy and safety by risk status in patients (pts) receiving atezolizumab (atezo) + bevacizumab (bev) vs sorafenib (sor) as first-line treatment for unresectable hepatocellular carcinoma (HCC)

P Galle
1   Universitätsklinik Mainz, I. Medizinische Klinik und Poliklinik, Mainz, Deutschland
,
RS Finn
2   Jonsson Comprehensive Cancer Center, Geffen School of Medicine at UCLA, Los Angeles, Vereinigte Staaten von Amerika
,
S Qin
3   People’s Liberation Army Cancer Center, Jinling Hospital, Nanjing, China
,
M Ikeda
4   National Cancer Center Hospital East, Kashiwa, Japan
,
M Ducreux
5   Gustave Roussy, Villejuif, Frankreich
,
T-Y Kim
6   Seoul National University College of Medicine, Seoul, Korea, Republik
,
M Kudo
7   Kindai University Faculty of Medicine, Department of Gastroenterology and Hepatology, Osaka, Japan
,
HY Lim
8   Samsung Medical Center, Sungkyunkwan University School of Medicin, Department of Medicine, Seoul, Korea, Republik
,
V Breder
9   Russian Cancer Research Center by NN Blikhin, Moscow, Russische Föderation
,
P Merle
10   Hospital La Croix-Rousse, Lyon, Frankreich
,
A Kaseb
11   The University of Texas MD Anderson Cancer Center, Department of Hemopathology, Houston, Vereinigte Staaten von Amerika
,
D Li
12   City of Hope Comprehensive Cancer Center and Beckman Research Institute, Department of Medical Oncology, Duarte, Vereinigte Staaten von Amerika
,
Y-H Feng
13   Division of Hematology and Oncology, Department of Internal Medicine, Chi-Mei Medical Center, Tainan, Taiwan, Republik China
,
W Verret
14   Genentech, Inc., South San Francisco, Vereinigte Staaten von Amerika
,
A Nicholas
14   Genentech, Inc., South San Francisco, Vereinigte Staaten von Amerika
,
L Li
15   Roche Product Development, Shanghai, China
,
N Ma
14   Genentech, Inc., South San Francisco, Vereinigte Staaten von Amerika
,
AX Zhu
16   Harvard Medical School, Massachusetts General Hospital Cancer Center, Boston, Vereinigte Staaten von Amerika
,
A-L Cheng
17   National Taiwan University Cancer Center, Taipei, Taiwan, Republik China
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    Background Based on the Ph III IMbrave150 trial (NCT03434379), atezo+bev has been approved and is standard of care for pts with unresectable HCC without prior systemic therapy. With an additional 12 mo of follow-up from the primary analysis (median, 15.6 mo), atezo+bev showed consistent clinically meaningful benefit/safety. We report results of updated analyses considering high-risk factors.

    Methods Pts were randomized 2:1 to receive atezo 1200 mg IV q3w + bev 15 mg/kg IV q3w or sor 400 mg PO BID until loss of clinical benefit or unacceptable toxicity. High-risk situation was defined as tumor invasion of the portal vein (PV) and/or the PV branch contralateral to the primarily involved lobe (Vp4), and/or bile duct (BD) invasion and/or tumor occupancy of ≥ 50 % of liver.

    Results In the ITT population, 64 (19 %) pts with atezo+bev and 37 (22 %) pts with sor were defined as high risk. 10 pts had BD invasion, 73 had Vp4-invasion and 31 had liver tumor occupancy of ≥ 50 %. 9 pts (atezo+bev arm) and 4 pts (sor arm) had 2 high-risk factors. OS, PFS and ORR all favored atezo+bev over sor, in both non-high- and high-risk patients (table). In safety-evaluable pts, Grade 3/4 treatment-related AEs (TRAEs) occurred in 122 (45 %) of 269 non-high-risk and 21 (35 %) of 60 high-risk atezo+bev pts. Grade 5 TRAEs occurred in 2 % non-high-risk and 2 % high-risk atezo+bev pts. Updated results will be provided.

    Conclusions Efficacy benefit was seen with atezo+bev vs sor regardless of risk features. HRs remained similar despite numerical differences in median OS between non-high-risk and high-risk pts. The overall safety data in the atezo+bev arm were comparable between non-high and high-risk pts and in line with the known safety profile of each drug. Earlier results presented @ AACR 2021.

    Tab. 1

    Efficacy Outcome in ITT, non-high and high-risk patients

    Non-High Risk

    High Risk

    ITT

    Atezo + Bev

    Sor

    Atezo + Bev

    Sor

    Atezo + Bev

    Sor

    Evaluable for OS or PFS/ORR, n

    272/263

    128/124

    64/63

    37/35

    336/326

    165/159

    Median OS (95 % CI), mo

    22.8 (19.1, 24.9)

    15.7 (13.2, 19.0)

    7.6 (6.6, 12.8)

    5.5 (4.1, 6.7)

    19.2 (17.0, 23.7)

    13.4 (11.4, 16.9)

    HR (95 % CI)

    0.68 (0.51, 0.91)

    0.62 (0.39, 1.00)

    0.66 (0.52, 0.85)

    Median PFS (95 % CI), mo*

    7.2 (6.5, 9.6)

    4.4 (4.0, 5.8)

    5.4 (4.0, 6.9)

    2.8 (2.5, 5.3)

    6.9 (5.7, 8.6)

    4.3 (4.0, 5.6)

    HR (95 % CI)

    0.61 (0.48, 0.78)

    0.74 (0.47, 1.17)

    0.65 (0.53, 0.81)

    Confirmed ORR, n (%)*

    81 (31)

    13 (10)

    16 (25)

    5 (14)

    97 (30)

    18 (11)

    Complete response, n (%)*

    20 (8)

    0

    5 (8)

    1 (3)

    25 (8)

    1 (1)

    HR, hazard ratio; IRF, independent review facility; NE, not estimable; ORR, objective response rate; OS, overall survival; PFS, progression-free survival. * Assessed by an IRF per RECIST 1.1.

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    Artikel online veröffentlicht:
    07. September 2021

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