Phase III study of SHR 1210 + Aitan shows prolonged survival in hepatocellular carcinoma
Jiangsu Hengrui Pharmaceuticals announced top-line results from the phase III study of SHR 1210 + Aitan (camrelizumab plus apatinib) vs. sorafenib as a first-line therapy for unresectable hepatocellular carcinoma (uHCC)
Camrelizumab plus apatinib significantly prolonged overall survival (OS) and progression-free survival (PFS), and improved overall response rate (ORR) vs. sorafenib, a standard first-line treatment for uHCC.
The study is a multinational, randomized, open-label trial and included 543 patients from 13 countries. The study was initiated in June 2019, and met the primary endpoint in April 2022.
Top-line data from the SHR-1210-III-310 study were included in the presentation at the Congress of the European Society for Medical Oncology (ESMO). This included the following: Median OS for camrelizumab + apatinib was 22.1 mos. [95% CI 19.1-27.2] vs. 15.2 mos. [13.0-18.5]; hazard ratio (HR) 0.62 [95% CI 0.49-0.80]; 1-sided p<0.0001. median pfs for camrelizumab + apatinib was 5.6 mos. [95% ci 5.5-6.3] vs. 3.7 mos. [2.8-3.7]; hr 0.52 [95% ci 0.41-0.65]); 1-sided p><0.0001. confirmed orr for camrelizumab + apatinib was 25.4% (95% ci 20.3-31.0), compared to 5.9% (3.4-9.4) for sorafenib. the findings were presented on september 10 during the annual esmo in paris.
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