Abstract 932P
Background
First-line atezo + bev has been approved in >70 countries based on significantly longer overall and progression-free survival (OS/PFS) vs sor in patients (pts) with unresectable hepatocellular carcinoma (HCC) at the primary analysis of IMbrave150 (NCT03434379). We report exploratory efficacy and safety in pts without MVI or EHS after 12 mo additional follow-up.
Methods
In this open-label, phase III study, 501 systemic treatment–naive pts with unresectable HCC, ≥1 measurable untreated lesion (RECIST 1.1), Child-Pugh A liver function and ECOG PS 0/1 were randomised 2:1 to atezo 1200 mg IV q3w + bev 15 mg/kg IV q3w or sor 400 mg bid. BCLC B pts or BCLC C pts without MVI or EHS were included in this analysis.
Results
At baseline, 111 pts did not have MVI or EHS. Of the 72 MVI− EHS− pts receiving atezo + bev, 37 (51%) had prior locoregional therapy (LRT) with 32 (44%) receiving at least one TACE. Of the 39 MVI− EHS− pts receiving sor, 24 (62%) had prior LRT with 20 (51%) receiving at least one TACE. At the 31 Aug 2020 data cutoff, median (m) OS in these pts was 24.6 mo with atezo + bev and 18.1 mo with sor (HR 0.58; 95% CI 0.34, 1.01); mPFS was 9.6 and 8.3 mo, respectively (HR 0.80; 95% CI 0.52, 1.26). See Table for responses by independent review facility (IRF) RECIST 1.1 and HCC modified RECIST (mRECIST). Complete response by IRF RECIST 1.1 was achieved in 7 atezo + bev pts (10%) and 0 sor pts. Treatment-related Grade 3/4 AEs occurred in 71 atezo + bev pts (49%) and 38 sor pts (47%). Any-grade bleeding/haemorrhage AEs occurred in 34% (Grade 3/4 11%) of atezo + bev and 32% (Grade 3/4 21%) of sor pts.
Conclusions
Atezo + bev is the standard of care for pts with unresectable HCC. The relative benefit of atezo + bev vs sor is maintained in pts without MVI or EHS, noting improved absolute results vs ITT. Safety outcomes were consistent with those in the ITT population. Table: 932P
| n (%) [95% CI] | IRF RECIST 1.1 | IRF HCC mRECIST | ||
| Atezo + Bev (n=68) | Sor (n=38) | Atezo + Bev (n=67) | Sor (n=38) | |
| Overall response rate | 24 (35) [24, 48] | 9 (24) [11, 40] | 29 (43) [31, 56] | 11 (29) [15, 46] |
| Complete response | 7 (10) [4, 20] | 0 [0, 9] | 10 (15) [7, 26] | 3 (8) [2, 21] |
| Partial response | 17 (25) [15, 37] | 9 (24) [11, 40] | 19 (28) [18, 41] | 8 (21) [10, 37] |
| Stable disease | 35 (51) [39, 64] | 17 (45) [29, 62] | 28 (42) [30, 54] | 16 (42) [26, 59] |
| Progressive disease | 4 (6) [2, 14] | 5 (13) [4, 28] | 4 (6) [2, 15] | 4 (11) [3, 25] |
| Not evaluable/missinga | 5 (7) | 7 (18) | 6 (9) | 7 (18) |
Data presented are in pts with measurable disease at baseline per IRF RECIST 1.1 or HCC mRECIST. a No post-baseline response assessment available or evaluable.
Clinical trial identification
NCT03434379.
Editorial acknowledgement
Medical writing assistance for this abstract was provided by Scott Battle, PhD, of Health Interactions, Inc.
Legal entity responsible for the study
F. Hoffmann-La Roche Ltd.
Funding
F. Hoffmann-La Roche Ltd.
Disclosure
M. Kudo: Financial Interests, Personal, Other, Honoraria: Eisai; Financial Interests, Personal, Other, Honoraria: Bayer; Financial Interests, Personal, Other, Honoraria: MSD; Financial Interests, Personal, Other, Honoraria: BMS; Financial Interests, Personal, Other, Honoraria: Lilly; Financial Interests, Personal, Other, Honoraria: EA Pharma; Financial Interests, Institutional, Research Grant: Gilead Sciences; Financial Interests, Institutional, Research Grant: Taiho; Financial Interests, Institutional, Research Grant: Sumitomo Dainippon Pharma; Financial Interests, Institutional, Research Grant: Takeda; Financial Interests, Institutional, Research Grant: Otsuka; Financial Interests, Institutional, Research Grant: EA Pharm; Financial Interests, Institutional, Research Grant: AbbVie; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Personal, Advisory Role: Eisai; Financial Interests, Personal, Advisory Role: Ono; Financial Interests, Personal, Advisory Role: MSD; Financial Interests, Personal, Advisory Role: BMS; Financial Interests, Personal, Advisory Role: Roche. R.S. Finn: Financial Interests, Personal, Other, Consultant: Bayer; Financial Interests, Personal, Other, Consultant: AstraZeneca; Financial Interests, Personal, Other, Consultant: Eisai; Financial Interests, Personal, Other, Consultant: Eli Lilly; Financial Interests, Personal, Other, Consultant: CStone; Financial Interests, Personal, Other, Consultant: Roche/Genentech; Financial Interests, Institutional, Research Grant: Eisai; Financial Interests, Institutional, Research Grant: Eli Lilly; Financial Interests, Institutional, Research Grant: Roche/Genentech. P.R. Galle: Financial Interests, Personal, Other, Consultant: Adaptimmune; Financial Interests, Personal, Other, Consultant: Bayer; Financial Interests, Personal, Other, Consultant: BMS; Financial Interests, Personal, Other, Consultant: AstraZeneca; Financial Interests, Personal, Other, Consultant: Sirtex; Financial Interests, Personal, Other, Consultant: MSD; Financial Interests, Personal, Other, Consultant: Eisai; Financial Interests, Personal, Other, Consultant: Lilly; Financial Interests, Personal, Other, Consultant: Ipsen; Financial Interests, Personal, Other, Consultant: Roche; Financial Interests, Institutional, Research Grant: Bayer; Financial Interests, Personal, Other, Sponsored Lectures (National or International): Adaptimmune; Financial Interests, Personal, Other, Sponsored Lectures (National or International): Bayer; Financial Interests, Personal, Other, Sponsored Lectures (National or International): BMS; Financial Interests, Personal, Other, Sponsored Lectures (National or International): AstraZeneca; Financial Interests, Personal, Other, Sponsored Lectures (National or International): Sirtex; Financial Interests, Personal, Other, Sponsored Lectures (National or International): MSD; Financial Interests, Personal, Other, Sponsored Lectures (National or International): Eisai; Financial Interests, Personal, Other, Sponsored Lectures (National or International): Lilly; Financial Interests, Personal, Other, Sponsored Lectures (National or International): Ipsen; Financial Interests, Personal, Other, Sponsored Lectures (National or International): Roche; Financial Interests, Personal, Other, Sponsored Lectures (National or International): Gilead. A. Zhu: Financial Interests, Other, Consultant: Lily; Financial Interests, Other, Consultant: Bayer; Financial Interests, Other, Consultant: Roche; Financial Interests, Other, Consultant: Merck; Financial Interests, Other, Consultant: Sanofi; Financial Interests, Other, Consultant: Exelixis; Financial Interests, Other, Consultant: Eisai. M.P. Ducreux: Financial Interests, Personal, Other, Sponsored Lectures (National or Internal): Roche; Financial Interests, Personal, Other, Sponsored Lectures (National or Internal): Amgen; Financial Interests, Personal, Other, Sponsored Lectures (National or Internal): Ipsen; Financial Interests, Personal, Other, Sponsored Lectures (National or Internal): Servier; Financial Interests, Personal, Other, Sponsored Lectures (National or Internal): Merk Serono; Financial Interests, Personal, Other, Sponsored Lectures (National or Internal): Bayer; Financial Interests, Personal, Other, Sponsored Lectures (National or Internal): Lilly; Financial Interests, Personal, Other, Consultant: Roche; Financial Interests, Personal, Other, Consultant: Amgen; Financial Interests, Personal, Other, Consultant: Bayer; Financial Interests, Personal, Other, Consultant: Merck Serono; Financial Interests, Personal, Other, Consultant: Servier; Financial Interests, Personal, Other, Consultant: Ipsen; Financial Interests, Personal, Other, Consultant: MSD; Financial Interests, Institutional, Research Grant: Roche; Financial Interests, Institutional, Research Grant: Bayer. A. Cheng: Financial Interests, Personal, Other, Consultant: AstraZeneca; Financial Interests, Personal, Other, Consultant: Bristol-Myers Squibb; Financial Interests, Personal, Other, Consultant: Eisai; Financial Interests, Personal, Other, Consultant: Merck Serono; Financial Interests, Personal, Other, Consultant: Novartis; Financial Interests, Personal, Other, Consultant: Ono Pharmaceutical; Financial Interests, Personal, Other, Consultant: Exelixis; Financial Interests, Personal, Other, Consultant: Nucleix; Financial Interests, Personal, Other, Consultant: Ipsen Innovation; Financial Interests, Personal, Other, Consultant: Bayer Healthcare; Financial Interests, Personal, Other, Consultant: Merck Sharp Dohme; Financial Interests, Personal, Other, Consultant: Roche/Genentech; Financial Interests, Personal, Other, Consultant: eiGene, CSR Pharma Group; Financial Interests, Personal, Other, Consultant: F. Hoffmann-La Roche; Financial Interests, Personal, Other, Consultant: IQVIA; Financial Interests, Personal, Other, Travel Support: Bayer Yakuhin; Financial Interests, Personal, Other, Travel Support: Roche/Genentech; Financial Interests, Personal, Other, Travel Support: IQVIA; Financial Interests, Personal, Speaker’s Bureau: Bayer Yakuhin; Financial Interests, Personal, Speaker’s Bureau: Novartis; Financial Interests, Personal, Speaker’s Bureau: Eisai; Financial Interests, Personal, Speaker’s Bureau: Ono Pharmaceutical; Financial Interests, Personal, Speaker’s Bureau: Amgen Taiwan. W. Verret: Financial Interests, Full or part-time Employment: Genentech, Inc. V.E. Gaillard: Financial Interests, Personal, Full or part-time Employment: Roche; Financial Interests, Personal, Stocks/Shares: Roche. A. Nicholas: Financial Interests, Personal, Stocks/Shares: Genentech, Inc.; Financial Interests, Personal, Full or part-time Employment: Genentech, Inc. R. Lencioni: Financial Interests, Personal, Other, Consultant: Roche/Genentech; Financial Interests, Personal, Other, Consultant: AstraZeneca; Financial Interests, Personal, Other, Consultant: Eisai.