Abstract 986P
Background
Atezo (anti-PD-L1) + bev (anti–VEGF) statistically significantly prolonged overall survival (OS) and progression-free survival (PFS) vs sorafenib in the phase III IMbrave150 study in patients with unresectable HCC. In the phase Ib study GO30140, atezo + bev statistically significantly increased PFS vs atezo. We present efficacy data from GO30140 patients who crossed over to atezo + bev following progression on atezo.
Methods
In GO30140 Arm F, 119 patients with unresectable HCC were randomised 1:1 to atezo 1200 mg IV + bev 15 mg/kg IV q3w (Arm F1) or atezo 1200 mg IV q3w (Arm F2). Patients in Arm F2 could cross over to atezo + bev after disease progression (PD) per RECIST 1.1. Investigator-assessed PFS and objective response rate (ORR) following crossover were evaluated.
Results
At the data cut on 14 June 2019, 26 of 59 patients in Arm F2 crossed over to atezo + bev following PD after a median 2.5-mo exposure to atezo monotherapy. Crossover patients’ baseline demographics were comparable with those of patients in Arms F2 and F1. With a median follow-up of 4.0 mo post crossover, 1 patient had a partial response (PR) with atezo + bev (ORR 3.8% vs 0% with atezo pre-crossover). The disease control rate was 53.8% with atezo + bev vs 30.8% with atezo pre-crossover. Median (95% CI) PFS post crossover was 5.4 mo (1.9-6.4 mo; 14/26 events) with atezo + bev vs 1.9 mo (1.8-2.1 mo; 26/26 events) with atezo pre-crossover. Best overall response (BOR) before and after crossover are shown in the table.
Conclusions
Recognizing the limitations of this exploratory post-hoc analysis, a subset of patients with unresectable HCC with PD on atezo monotherapy may benefit from the addition of bevacizumab. These and other GO30140 data support combination therapy Table: 986P
BOR Before vs After Crossover (n = 26)
BOR With Atezo Monotherapy Pre- Crossover | BOR With Atezo + Bev Post Crossover, n (%) | |||
PR | SD | PD | NE/Missing | |
PD (n = 18) | 1 (5.6) | 9 (50.0) | 6 (33.3) | 2 (11.1) |
SD (n = 8) | – | 4 (50.0) | – | 4 (50.0) |
NE, not evaluable; SD, stable disease.
.Clinical trial identification
NCT02715531.
Editorial acknowledgement
Medical writing support provided by Samantha Santangelo of Health Interactions and funded by F. Hoffmann-La Roche, Ltd.
Legal entity responsible for the study
F. Hoffmann-La Roche.
Funding
F. Hoffmann-La Roche.
Disclosure
A.R.R. He: Speaker Bureau/Expert testimony: Eisai; Speaker Bureau/Expert testimony: Exelixis; Speaker Bureau/Expert testimony, Research grant/Funding (self): Merck; Speaker Bureau/Expert testimony: Bayer; Speaker Bureau/Expert testimony: BMS; Speaker Bureau/Expert testimony, Research grant/Funding (self): Genentech. K-H. Lee: Honoraria (self): AstraZeneca; Honoraria (self): Roche; Advisory/Consultancy: Bayer; Advisory/Consultancy: Eisai; Advisory/Consultancy: Ono Pharmaceutical; Advisory/Consultancy: Samsung Bioepis. C-H. Hsu: Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution): Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (institution), Travel/Accommodation/Expenses: Merck Sharp & Dohme; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Ono Pharmaceutical; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Roche/Genentech; Advisory/Consultancy: Lilly; Advisory/Consultancy, Research grant/Funding (institution): Merck Serono; Research grant/Funding (institution): AstraZeneca ; Research grant/Funding (institution): BeiGene ; Research grant/Funding (institution): NuCana BioMed; Research grant/Funding (institution): Taiho Pharmaceutical. J. Lee: Advisory/Consultancy: Oncologie; Advisory/Consultancy: Seattle Genetics; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): Lilly; Research grant/Funding (institution): Merck Sharp & Dohme. M. Morimoto: Research grant/Funding (institution): Eli Lilly ; Research grant/Funding (institution): MSD; Research grant/Funding (institution): AstraZeneca; Research grant/Funding (institution): BeiGene; Research grant/Funding (institution): Bayer. W. Verret: Full/Part-time employment: Roche/Genentech. S.P. Hack: Shareholder/Stockholder/Stock options, Full/Part-time employment: Genentech. J. Spahn: Shareholder/Stockholder/Stock options, Full/Part-time employment: Genentech/Roche. B. Liu: Shareholder/Stockholder/Stock options, Full/Part-time employment: Genentech/Roche. All other authors have declared no conflicts of interest.