On January 18, 2024 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 patients who have limited or inadequate therapeutic options, reported that it will present two posters and give an Industry Expert Theater presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Gastrointestinal Cancers Symposium (ASCO GI) (Press release, Elevar Therapeutics, JAN 18, 2024, View Source [SID1234639327]).
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The posters examine post hoc analyses of clinical data and patient-reported outcomes tied to Elevar’s CARES-310 study (NCT03764293), which assessed the combination of the company’s drug candidates camrelizumab, a PD-1 inhibitor, in combination with rivoceranib, an oral TKI, as a first-line therapy for unresectable hepatocellular carcinoma (uHCC).
ASCO GI will be held Jan. 18-20, 2024, at the Moscone Convention Center (West) in San Francisco, and online. Elevar’s poster presentations are:
Poster Session B: Cancers of the Pancreas, Small Bowel, and Hepatobiliary Tract
Date and Time: Jan. 19, 2024, at 12:30 p.m. – 2 p.m. PT Abstract Number: 509 Abstract Title: Impact of baseline liver function on survival outcomes in patients with unresectable hepatocellular carcinoma (uHCC) treated with camrelizumab + rivoceranib vs sorafenib: A post hoc analysis of study CARES-310.
Date and Time: Jan. 19, 2024, at 12:30 p.m. – 2 p.m. PT Abstract Number: 456 Abstract Title: Patient-reported outcomes (PROs) <65 or ≥ 65 years old (yo) from CARES-310 camrelizumab + rivoceranib vs sorafenib as first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC).
Industry Expert Theater presentation details:
Date and Time: Jan. 19, 2024; 5:15 p.m. – 6 p.m. PT Presentation Title: Impact of liver function on survival outcomes during treatment with camrelizumab + rivoceranib (cam+rivo) vs sorafenib in uHCC patients: therapeutic implications Speaker: Natalia Raphael, Ph.D., Elevar executive director of medical affairs
Session Description: Impact of baseline liver reserve and drug induced hepatotoxicity (DIH) on survival outcomes assessed; time to resolution/discontinuation, impact on QoL of DIH determined. The results of this post-hoc analysis may have implications for selection of initial and subsequent therapies for uHCC patients.
"Elevar is pleased that CARES-310 continues to yield results that support the combination of camrelizumab plus rivoceranib as a potentially important therapy for those confronted with hepatocellular carcinoma," said Saeho Chong, Elevar chief executive officer. "We look forward to detailing these findings while meeting with our peers at ASCO (Free ASCO Whitepaper) GI."
One ASCO (Free ASCO Whitepaper) GI poster is a post hoc analysis of the impact of baseline liver function on survival outcomes in patients with uHCC treated with camrelizumab and rivoceranib in CARES-310. The analysis found the efficacy of camrelizumab plus rivoceranib was superior to sorafenib regardless of baseline liver function as measured by both albumin-bilirubin (ALBI) grade and Child-Pugh (CP) class. Despite a higher rate of grade 3/4 adverse effects, there was no detrimental effect of camrelizumab plus rivoceranib on liver function and overall survival in patients with both mildly and moderately preserved liver function compared to sorafenib.
The other poster assessed patient-reported outcomes during CARES-310. Camrelizumab plus rivoceranib demonstrated clinically meaningful benefits in key aspects of the patient experience. Although patients treated with camrelizumab and rivoceranib exhibited higher rate of treatment-related adverse events, the combination did not adversely impact quality of life when compared to sorafenib.
Supported by the CARES-310 results, Elevar and Jiangsu Hengrui Pharmaceuticals Co., Ltd. in May 2023 submitted a new drug application (rivoceranib) and biologics license application (camrelizumab) to the U.S. Food and Drug Administration (FDA) for the combination as a first-line treatment option for uHCC. The FDA assigned Prescription Drug User Fee Act (PDUFA) target action dates in May 2024.
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 Rivoceranib Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), 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 currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Ongoing clinical studies include 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 was the first TKI approved in gastric cancer in China (November 2014). It is also approved in China in combination with camrelizumab as a first-line treatment for uHCC (February 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 in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in uHCC (U.S.). 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. Rivoceranib, under the name apatinib, is also approved in China for advanced gastric cancer and in second-line advanced HCC by the Chinese-territory license-holder, Jiangsu Hengrui Pharmaceuticals Company Ltd., (Hengrui Pharma), under the brand name Aitan.
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 6,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer, and breast cancer) 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 uHCC (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. Elevar has rights to commercialize and develop Hengrui Pharma’s camrelizumab in combination with rivoceranib for unresectable hepatocellular carcinoma (uHCC) worldwide, excluding Greater China Region and Korea (Oct. 2023).