173P - Regorafenib in patients (pts) with unresectable hepatocellular carcinoma (uHCC) in real-world practice in Asia: Interim results from the observational REFINE study

Background

In the phase III RESORCE trial, regorafenib improved overall survival (OS) vs placebo in pts with uHCC who progressed on sorafenib. The international, prospective REFINE study was designed to evaluate regorafenib in pts with uHCC in routine practice. We present interim results for pts enrolled in REFINE in Korea, China, and Taiwan.

Methods

REFINE is an ongoing observational study that recruited patients with uHCC for whom a decision to treat with regorafenib was made by the treating physician prior to enrollment according to the local health authority approved label. A planned interim analysis was performed when the first 500 pts in the global cohort had been observed for ≥4 months. The primary aim is to assess treatment-emergent adverse events (TEAEs; NCI-CTCAE v4.03). Secondary endpoints include OS, progression-free survival, and tumor response. Tumor response and progression are assessed per investigator according to local standard.

Results

In the interim analysis, a total of 182 pts were enrolled from Korea (n=127; 70%), China (n=48; 26%), and Taiwan (n=7; 4%). The median age was 60 years (range 21–90); 80% were male. At study entry, proportions of pts with ECOG performance status 0/1/≥2 were 37%/49%/5%; proportions with Child–Pugh A/B/C class were 70%/5%/1% (missing/not evaluable: 24%). The initial daily regorafenib dose was 160 mg in 70% of pts and 120 mg/80 mg in 14%/15%; 1 pt started at 40 mg. The mean initial daily dose was 142 mg (standard deviation 31). Median treatment duration was 3.2 months (interquartile range 1.9–9.3). The most frequent TEAEs (reported in ≥5% patients) are shown in the table. Effectiveness results will be presented.

Conclusions

In this interim analysis of pts from Asia in the observational REFINE study, the TEAEs reported were consistent with those reported in the phase III RESORCE trial, although incidence rates of some TEAEs were lower than in RESORCE Table: 173P

Clinical trial identification

NCT03289273.

Editorial acknowledgement

Editorial assistance in the writing of this abstract was provided by Jennifer Tobin of OPEN Health Medical Communications (Choice), with financial support from Bayer.

Legal entity responsible for the study

Bayer.

Funding

Bayer.

Disclosure

H.Y. Lim: Advisory/Consultancy: Bayer; Advisory/Consultancy: Ipsen; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Eisai; Advisory/Consultancy: Ono Pharmaceutical. Y.J. Kim: Honoraria (self): Eisai; Honoraria (self), Advisory/Consultancy: AbbVie; Honoraria (self), Advisory/Consultancy, Research grant/Funding (self): Bristol-Myers Squibb; Honoraria (self), Research grant/Funding (self): BTG; Honoraria (self): Bayer; Honoraria (self): MSD; Honoraria (self), Advisory/Consultancy, Resarch grant/Funding (self): Gilead Sciences; Research grant/Funding (self): AstraZeneca; Research grant/Funding (self): Roche. Y-H. Huang: Advisory/Consultancy: Gilead Sciences; Advisory/Consultancy: Bristol-Myers Squibb; Advisory/Consultancy: MSD; Advisory/Consultancy: Bayer. C-H. Hsu: Honoraria (self), Advisory/Consultancy: Bristol-Meyers Squibb; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Ono Pharmaceutical; Honoraria (self), Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: MSD; Honoraria (self), Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy: Lilly; Advisory/Consultancy: Genentech; Advisory/Consultancy: Merck Serono. H.C. Lee: Advisory/Consultancy, Research grant/Funding (self): AstraZeneca; Research grant/Funding (self): Bayer; Research grant/Funding (self): Roche; Research grant/Funding (self): Merck; Research grant/Funding (self): Bristol-Myers Squibb. S. Fiala-Buskies: Shareholder/Stockholder/Stock options, Full/Part-time employment: Bayer. S. Kapur: Full/Part-time employment: Bayer. All other authors have declared no conflicts of interest.