792 - A Randomized Multicentered Phase 2 Study to Evaluate SHR-1210 (PD-1 Antibody) in Subjects with Advanced Hepatocellular Carcinoma (HCC) who Failed or Intolerable to Prior Systemic Treatment

Background

PD-1 antibodies have brought promising benefit to advanced hepatocellular carcinoma (HCC) patients (pts) who had been treated with sorafenib etc. Camrelizumab (SHR-1210), a fully humanized anti–PD-1 IgG4 monoclonal antibody, was well tolerated with promising antitumor activity observed in phase 1 trials.

Methods

In this phase 2 trial, HCC pts who progressed on or were intolerant to at least one line of prior systemic therapies were randomized (1:1) to camrelizumab 3 mg/kg iv.gtt for q2w or q3w group. The primary endpoints were confirmed objective response rate (ORR) by blinded independent central review according to RECIST v1.1 criteria and 6-month (6-mo) overall survival (OS) rate.

Results

From 15 Nov. 2016 to 16 Nov. 2017, 220 pts at Chinese national-wide 13 sites were randomized and 217 were treated (109 in q2w and 108 in q3w group). As of 16 May 2018, the ORR was 13.8% (95% CI 9.5–19.1) and 6-mo OS rate was 74.7% (95% CI 68.3–79.9). Median time to response was 2.0 mo (range 1.7–6.2). Of the 30 responses, 22 were ongoing, and median duration of response was not reached (range 2.5–15.4⁺ mo). Disease control rate was 44.7% (95% CI 38.0–51.6). Median time to progression was 2.6 mo (95% CI 2.0–3.3) and median progression-free survival was 2.1 mo (95% CI 2.0–3.2). Median OS was not reached. The most common treatment related adverse events (TRAEs, ≥20.0%) were reactive cutaneous capillary endothelial proliferation (RCEP, 66.8%, all in grade ≤2), increased AST (24.4%), increased ALT (23.0%) and proteinuria (23.0%). Exploratory analysis indicated that pts experienced RCEP had significantly higher ORR (18.9% vs. 5.8%, P=0.0022). Pts in the q2w or q3w group had comparable efficacy and TRAEs incidence (Table). The prior sorafenib-exposed only pts seemed to have superior outcomes (Table).

Conclusions

Camrelizumab showed high ORR, durable response and acceptable toxicities in Chinese pretreated advanced HCC pts.

Clinical trial identification

Clinical trial identification: NCT02989922

Editorial Acknowledgement

None