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Author : adminDate : 2020-09-15 12:00

HLB announces Rivoceranib Combo Phase II Results on Liver Cancer

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.