On September 1, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for cancer patients, reported that in a post hoc analysis of its Phase 3 CARES-310 study, camrelizumab, an anti-PD-1 antibody, plus rivoceranib, an oral TKI, demonstrated a clinically meaningful progression-free survival (PFS) benefit across all age subgroups when compared to sorafenib in patients with unresectable hepatocellular carcinoma (uHCC).
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The poster, titled "Younger Age and Clinical Outcomes in Patients with Unresectable Hepatocellular Carcinoma Treated with Camrelizumab + Rivoceranib vs Sorafenib (CARES-310)," will be on display throughout the International Liver Cancer Association 2026 Annual Conference, which runs Sept. 3-5 at Le Plaza Hotel in Brussels. Elevar is sponsoring the conference’s welcome reception on Sept. 3., from 6:15-7:30 p.m. (CET).
"We remain deeply committed to gaining FDA approval and helping patients confronted with hepatocellular carcinoma, because the scientific data demonstrates that the combination of camrelizumab and rivoceranib shows consistent potential to extend survival when compared to currently approved treatments," said Dong-Gun Kim, chief executive officer of Elevar. "This post-hoc analysis of CARES-310 further demonstrates the broad potential of the combination. We are excited to share it with our peers at the ILCA Annual Conference."
The post-hoc, exploratory analysis concluded that:
Camrelizumab plus rivoceranib improved median overall survival (mOS) versus sorafenib in patients aged <50 years (21.5 vs. 15.2 months; HR 0.7; 95% CI, 0.47-1.06; P=0.0445*) and ≥50 years (23.9 vs. 15.2 months; HR 0.6; 95% CI, 0.47-0.77; P<0.0001), with a numerically longer mOS also observed in patients <40 years (24.2 vs. 15.2 months; HR 0.82; 95% CI, 0.4-1.72; P=0.2982)^.
Camrelizumab plus rivoceranib also improved mPFS versus sorafenib across age subgroups, including patients <50 years (5.5 vs. 2.7 months; HR 0.53; 95% CI, 0.37–0.77; P=0.0004), ≥50 years (6.2 vs. 3.7 months; HR 0.56; 95% CI, 0.45–0.72; P<0.0001), and <40 years (5.5 vs. 2.2 months; HR 0.56; 95% CI, 0.29–1.12; P=0.0485)^.
Treatment-related adverse events (TRAEs) were similar across age subgroups. The most common (≥5%) grade 3-4 TRAE was hypertension for camrelizumab plus rivoceranib and palmar-plantar erythrodysesthesia syndrome for sorafenib, regardless of age.
*All P values are one sided.
^Median follow-up time is 22.1 months.
Lead poster author Arndt Vogel, M.D., Ph.D., scientist in the Division of Gastroenterology and Hepatology at Toronto General Hospital Research Institute, and a medical oncologist at the UHN-Princess Margaret Cancer Centre at the University of Toronto, will present the poster #P-106 during the conference Poster Tour, Friday, Sept. 4, 10:30-11 a.m.
"The analysis of camrelizumab plus rivoceranib by age subgroups provides further evidence that the combination has potential to improve outcomes across diverse healthcare settings," said Dr. Vogel. "It has also been investigated across early, intermediate, and advanced stages of HCC, both alone and in combination with locoregional therapies, and has consistently demonstrated clinically meaningful antitumor activity together with a manageable safety profile. These findings highlight the potential of this regimen to become an important component of multidisciplinary HCC management."
For more information about Elevar, visit Elevartx.com.
About Hepatocellular Carcinoma
Hepatocellular Carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation, which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. More than 800,000 people worldwide are diagnosed with liver cancer each year and it is also a leading cause of cancer deaths, accounting for more than 700,000 annually, according to the American Cancer Society.
About Rivoceranib
Rivoceranib, an oral small-molecule tyrosine kinase inhibitor (TKI), is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Several clinical studies were completed in patients with uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib, under the name apatinib (Aitan), was the first TKI approved in gastric cancer in China (October 2014). It was also approved in China in combination with camrelizumab as a first-line treatment for unresectable or metastatic HCC (January 2023). The drug 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. Orphan drug designations have been granted for gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Hengrui Pharma, is the license-holder of rivoceranib in the Chinese -territory. As previously disclosed, in July, Elevar received a Complete Response Letter from the FDA regarding its NDA for rivoceranib in combination with camrelizumab due to deficiencies identified during an inspection of the manufacturing site. Elevar is working closely with Hengrui to address the identified issues and prepare for resubmission of the application.
About Camrelizumab
Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to 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 eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for HCC (first-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. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab for commercialization from Hengrui Pharma worldwide excluding Greater China and Korea.
(Press release, Elevar Therapeutics, SEP 1, 2026, View Source [SID1234670516])