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- This is the first positive pivotal trial to show survival benefits with a PD-1 inhibitor plus an anti-angiogenic tyrosine kinase inhibitor for unresectable hepatocellular carcinoma (uHCC)
- Combination therapy has the potential to offer a new treatment option for patients with uHCC, a condition with an urgent medical need
- Hengrui anticipates submission of an FDA Biologic License Application for camrelizumab as a treatment option for HCC soon
PARIS, Sept. 10, 2022 /PRNewswire/ — Jiangsu Hengrui Pharmaceuticals Co., Ltd., one of the largest biopharmaceutical companies headquartered in Chinatoday announced top-line results from the phase 3 study of camrelizumab (anti-PD1 checkpoint inhibitor) combined with rivoceranib (apatinib) vs. sorafenib as a first-line therapy for uHCC. Camrelizumab plus rivoceranib 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 2019and met the primary endpoint in April 2022. Top-line data shown below were included in the presentation at the Congress of the European Society for Medical Oncology (ESMO).
- Median OS for camrelizumab + rivoceranib 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 + rivoceranib 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 + rivoceranib was 25.4% (95% CI 20.3-31.0), compared to 5.9% (3.4-9.4) for sorafenib.
“We and others have established the validity of immune-checkpoint inhibition for the treatment of HCC. The combination of camrelizumab plus rivoceranib phase 3 trial results demonstrate the combo treatment as a new …
Full story available on Benzinga.com
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