Camrelizumab in Combination with Rivoceranib (Apatinib) Significantly Prolonged Overall Survival and Progression-Free Survival vs. Sorafenib in Patients with Unresectable Hepatocellular Carcinoma in a Multinational Phase 3 Trial, a Joint Program with Elevar Therapeutics

• 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 China, today 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 2019, and 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 first-line treatment option for uHCC," said Dr. Lianshan Zhang, president of global R&D, Board Director of Hengrui Pharma. "We continue to work with our partner Elevar to bring this combination therapy to HCC patients around the world who could be benefited by this new treatment option."

"The results from this large multinational, randomized phase 3 study confirmed the robust progression-free survival and overall survival benefit in the first line of uHCC patient population and confirmed our understanding of the clinical benefit this combination therapy may offer patients with uHCC. With the solid and consistent data shown not only in ITT population but also in each subgroup population, we are looking forward to providing a new treatment option for uHCC patients!" said Amily Zhang, Vice President, Chief Medical Officer (Oncology) of Hengrui Pharma.

The findings were presented on September 10 during the annual ESMO in Paris.

"Camrelizumab (C) plus rivoceranib (R) vs. sorafenib (S) as first-line therapy for unresectable hepatocellular carcinoma (uHCC): a randomized, phase 3 trial" was shared as a late-breaking proffered paper presentation at ESMO on September 10, 8:40 a.m. – 8:50 a.m. CEST, location 7.1C – Cannes Auditorium. The session title is Proffered Paper Session 1: GI, upper digestive.

About SHR-1210-III-310 Trial

The SHR-1210-III-310 study (ClinicalTrials.gov, NCT03764293) is a randomized, open-label, phase 3 trial conducted in 95 study sites across 13 countries/regions to investigate the efficacy and safety of camrelizumab plus rivoceranib versus sorafenib as first-line therapy in patients with incurable, locally advanced or metastatic HCC who had not received previous systematic treatment. The primary endpoints were overall survival and progression-free survival as assessed by the blinded independent review committee according to Response Evaluation Criteria in Solid Tumors version 1.1. A total of 543 patients were randomized 1:1 to receive camrelizumab (200 mg intravenously once every two weeks) plus rivoceranib (250 mg orally once daily) or sorafenib (400 mg orally twice daily). This study was sponsored by Hengrui Pharma and co-funded by Elevar Therapeutics.

About Hepatocellular Carcinoma (HCC)

HCC is the most common type of primary liver cancer. It most frequently occurs in people with chronic liver diseases, such as cirrhosis caused by hepatitis B or hepatitis C infection. HCC typically has a poor prognosis and a lack of treatment options and is therefore a condition with an urgent medical need.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody targeting the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer etc.) and treatment settings.

Camrelizumab, under the brand name AiRuiKa^®, is currently approved for 8 indications in China, including monotherapy for the treatment of HCC (second-line), relapsed/refractory classic Hodgkin's lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma, and nasopharyngeal carcinoma in the first-line setting. FDA granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021. In April 2020, Hengrui Pharma licensed the Korean rights of camrelizumab to CrystalGenomics Inc., a biotech company based in the Republic of Korea.

About Rivoceranib (apatinib)

Rivoceranib (Apatinib) is the first small-molecule tyrosine kinase inhibitor (TKI) approved in gastric cancer in China (December 2014). Rivoceranib is a highly potent inhibitor of vascular endothelial growth factor receptor 2 (VEGFR-2), a primary pathway for tumor angiogenesis. VEGFR-2 inhibition is a clinically validated approach to limit tumor growth and disease progression. Rivoceranib is co-developed by Hengrui Pharma in China and by Elevar Therapeutics, Inc. globally (excluding China). It has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Clinical studies are ongoing in multiple solid tumor types including gastric cancer (as a monotherapy and in combination with paclitaxel), hepatocellular carcinoma (HCC) (in combination with camrelizumab), adenoid cystic carcinoma (as monotherapy) and colorectal cancer (in combination with Lonsurf^®). Orphan drug designations have been granted in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in HCC (U.S.). Elevar holds the global rights (excluding China) and has partnered for the development and marketing of rivoceranib with HLB-LS in South Korea. Rivoceranib, under the name apatinib, is currently approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Hengrui Pharma, under the brand name Aitan^®.

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Hengrui Pharma is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui Pharma ranked the 24th among the top 1,000 global pharma companies in 2021¹. Hengrui has been on the Pharma Exec's annual listing of the top global pharmaceutical companies for the fourth consecutive year, rising from the 47th in 2019 to the 32nd in 2022².

1.     https://torreya.com/publications/pharma-1000-report-torreya-2021-11-08.pdf.

2.     https://www.pharmexec.com/view/2022-pharm-exec-top-50-companies

SOURCE Jiangsu Hengrui Pharmaceuticals Co., Ltd.