Abstract 985P
Background
In a multicenter, open-label, two administration methods parallel-group, randomized, phase II study in patients with previously treated advanced hepatocellular carcinoma (HCC), camrelizumab showed potent anti-tumor activity (objective response rate, 14.7% [95% CI 10.3–20.2]; 6-month overall survival [OS] rate, 74.4% (95% CI 68.0–79.7) and acceptable safety profile (Lancet Oncol. 2020. 21(4):571-580). Herein, we report the data from a two-year follow-up analysis and potential benefit of treatment with camrelizumab beyond progression.
Methods
From Nov 15, 2016 to Nov 16, 2017, 217 patients were treated with camrelizumab 3 mg/kg intravenously every 2 or 3 weeks. Treatment beyond first RECIST-defined progression (TBP) was allowed according to protocol-specified criteria.
Results
At data cutoff (Dec 16, 2019; median duration of follow-up, 13.2 months [IQR 5.7–25.8]), 14 (43.8%) of the 32 responses per blinded independent central review were ongoing. The median duration of response (DoR) was not reached (range 2.5–30.5+ months). The estimated DoR rates at 12, 18, and 24 months were 68.3% (95% CI 47.7–82.2), 59.8% (95% CI 38.8–75.6), and 53.1% (95% CI 31.0–71.0), respectively. Deaths were reported for 146 (67.3%) of the 217 patients. The median OS was 14.2 months (95% CI 11.5–16.3). The 18- and 24-month OS rates were 41.3% (95% CI 34.6–47.9) and 33.7% (95% CI 27.3–40.2), respectively. In total, 172 patients experienced RECIST-defined progression per investigator assessment, of whom 102 received TBP while 70 did not (non-TBP). The median OS was 16.9 months (95% CI 13.3–22.6) in the TBP group vs. 9.4 months (95% CI 5.8–14.8) in the non-TBP group, and the 18- and 24-month OS rates were 47.5% (95% CI 37.3–56.9) vs. 33.1% (95% CI 22.3–44.3) and 38.8% (95% CI 29.2–48.4) vs 23.2% (95% CI 13.8–34.1), respectively. No new safety signals of camrelizumab were observed in the TBP group.
Conclusions
With prolonged follow-up, camrelizumab continues to demonstrate durable response and long survival in pre-treated advanced HCC patients with manageable toxicities, especially in those who continued treatment beyond RECIST-defined first progression demonstrated.
Clinical trial identification
CTR20160871, Nov 14, 2016; NCT02989922, Dec 12, 2016.
Editorial acknowledgement
None
Legal entity responsible for the study
Jiangsu Hengrui Medicine Co. Ltd, China.
Funding
Jiangsu Hengrui Medicine Co. Ltd, China.
Disclosure
L. Wang, C. Chen, J. Zou: Full/Part-time employment: Jiangsu Hengrui Medicine Co., Ltd. All other authors have declared no conflicts of interest.