Results of Phase 2 clinical trials for
Rivoceranib liver cancer were announced at 'ESMO Virtual Congress 2020'. The
ESMO is an annual European conference on cancer research, which will be held
online from September 19-21. According to related industries, one of the most
outstanding papers published this time is "Rivoceranib" (Chinese name
Apatinib), which is published by several research institutes, including Hengrui
Medicine. More than 20 papers on Rivoceranib will be presented at the
conference in the form of oral presentations and posters.
The abstract of the paper are as follows:
983P - Camrelizumab (C) in combination with
apatinib (A) in patients with advanced hepatocellular carcinoma (RESCUE): An
open-label, multi-center, phase II trial
Presentation Number
983P
Speakers
Jianming Xu (Beijing, China)
Date
17.09.2020
Abstract
Background
Combination of checkpoint inhibitors (CPIs)
with anti-angiogenic agents are emerging as potential novel treatment options
of hepatocellular carcinoma (HCC). Here we assessed the efficacy and safety of
C+A in patients (pts) with advanced HCC.
Methods
This phase II study was conducted at 25
study sites in China. Pts with advanced HCC, treatment-naive or failure to
sorafenib or donafenib were enrolled. Pts received intravenous C 200 mg every 2
weeks plus A 250 mg qd. The primary endpoint was objective response assessed by
independent central review per RECIST v1.1.
Results
From Mar 2018 to Jan 2019, 70 pts in
first-line setting and 120 pts in second-line setting were enrolled and
received treatment of C+A. 168 (88%) of 190 pts were with HBV infection. As of
Jan, 2020, median follow-up was 16.7 months and 14.0 months in the first-line
and second-line treatment cohort, respectively. The objective response rate
(ORR) assessed by independent central review per RECIST v1.1 was 34% and 23%;
ORR assessed by independent central review per mRECIST was 46% and 25%; the
12-month overall survival (OS) rate was 75% and 68%, respectively. As of Apr
2020, the 18-month OS rate was 58% in the first-line cohort (table). Overall,
147 (77%) pts had grade ≥3 treatment-related AEs, with the most common being
hypertension (34%), and increased γ-GT (12%). Twenty-three (12%) pts
discontinued the treatment of either drug due to a treatment-related AE. Table:
983P
Efficacy results in two cohorts
First-line cohort (N = 70) Second-line cohort (N = 120)
RECIST v1.1* mRECIST*
RECIST v1.1* mRECIST*
ORR, % (95% CI) 34 (23, 47)
46 (34, 58) 23 (15, 31) 25 (18, 34)
DCR, % (95% CI) 77 (66, 86)
79 (67, 88) 76 (67, 83) 76 (67, 83)
mDoR, months (95% CI) 14.8 (5.5, NR) NR (5.8, NR) NR
NR
mPFS, months (95% CI) 5.7 (5.4, 7.4) 6.4 (4.8, 9.2) 5.5 (3.7, 5.6) 5.5 (3.7, 7.3)
12-month OS, % (95% CI) 75 (63, 84)
68 (59, 76)
18-month OS, % (95% CI) 58 (46, 69)
NE
*Independent central review.
Conclusions
C+A provided high ORR, durable response
with a manageable safety profile in advanced HCC pts. Notably, the remarkable
survival benefit might suggest C+A is a promising strategy in advanced HCC pts.
Clinical trial identification
NCT03463876.
Legal entity responsible for the study
Jiangsu Hengrui Medicine Co., Ltd.
Funding
Jiangsu Hengrui Medicine Co., Ltd.
Disclosure
Q. Wang: Full/Part-time employment: Jiangsu
Hengrui Medicine Co., Ltd. All other authors have declared no conflicts of
interest.