event-trade登录编辑
GlobeNewswire PharmaceuticalsQwen · 实盘不做把握 9/10不做原因:无增量信息
北京时间·🕒 发布 20:00:00·⟳ 抓取 20:02:16·⚡ 决策 09-01 21:04:14 +1h01m·55.9 天前

Elevar Therapeutics宣布将在ILCA年会展示CARES-310试验按年龄亚组的事后分析海报

本次事件是已发表CARES-310 III期试验数据的事后年龄亚组分析海报展示,不含任何新临床数据、新适应症、新审批进展或新收入催化剂。药物组合已在中国获批(2023年1月),美国FDA路径因2026年7月CRL而受阻。海报展示(非口头报告)对股价无催化价值,不构成可交易的增量信息。

📄 原文GlobeNewswire Pharmaceuticals↗ 原文
In post hoc analysis of CARES-310 trial, combination improved mPFS versus sorafenib across age subgroups Combination al…
不做 HLB Co., Ltd.(028300.KQ)
事后亚组分析海报展示不含新增信息量;2026年7月FDA CRL已确认美国上市路径受阻,本次公告不改变任何监管或商业化现状,无交易价值
不做 恒瑞医药(600276.SH)
camrelizumab+rivoceranib组合已在中国获批并商业化,事后年龄亚组分析不改变中国市场的收入前景或任何新适应症预期,无增量催化
展开详情(成交明细 / 研究档案 / 原文全文 / 决策记录链)

研究档案

结论摘要

Elevar宣布在ILCA年会展示CARES-310事后年龄亚组分析海报。CARES-310主结果早已发表,该组合已在中国获批一线uHCC(2023年1月)。事后分析确认了主试验方向(各年龄组均获益),无新发现。2026年7月FDA因生产现场检查缺陷发出CRL,美国上市路径受阻。海报展示是学术会议最低层级的呈现形式,不含新数据、新审批、新商业化信息。对HLB(韩国)和恒瑞医药(A股)均无增量催化。

🔎 新鲜度:最早出现 2026-09-01 · 扩散 low · price-in 风险 low ↗

先例如何影响了这次决策

对本次决策的影响:事件为事后分析海报展示,无需先例定价

方向:无适用先例

涨幅量级:无需校准——事件本身不构成可交易催化

原文全文

展开原文 · 8,450 字
In post hoc analysis of CARES-310 trial, combination improved mPFS versus sorafenib across age subgroups
Combination also improved mOS versus sorafenib in patients <50 years and ≥50 years
Elevar is sponsoring Sept. 3 welcome reception at ILCA Annual Conference
BRUSSELS, Sept. 01, 2026 (GLOBE NEWSWIRE) -- 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, today announced 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).
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.
About Elevar Therapeutics
Elevar Therapeutics, Inc. is a fully integrated biopharmaceutical company built on the promise of elevating treatment outcomes for cancer patients. A subsidiary of HLB Co., Ltd. based in Fort Lee, New Jersey, Elevar’s expertise is rooted in oncology and grounded in compassion. Our team of experienced scientists and industry leaders is highly focused on identifying and developing medicines for complex yet under-treated health conditions, with a shared goal of making a meaningful difference in the lives of patients. For more information, follow us on
LinkedIn
and
X
or visit
ElevarTX.com.
Media Contact:
Rosemary Ostmann
RoseComm
rostmann@rosecomm.com
(201) 615-7751

决策记录链 · 只追加

每次领取产生一条记录,重新决策追加一条并以 supersedes 指向被替代的记录(ADR 0014)。

这条决策早于决策账本(2026-10-08 起逐条追加),没有追加记录。