Neoadjuvant and Adjuvant Sintilimab Combined with Chemoradiotherapy Versus Chemoradiotherapy Alone in Stage TanyN3M0 Nasopharyngeal Carcinoma: a Multicenter, Open-label, Randomized Phase II Clinical Trial

To evaluate the efficacy and safety of neoadjuvant and adjuvant Sintilimab combined with chemoradiotherapy versus chemoradiotherapy alone in stage TanyN3M0 nasopharyngeal carcinoma. The primary endpoint was 2-year failure-free survival (FFS). Secondary endpoints included 2-year overall survival (OS), distant failure-free survival (DFFS), locoregional failure-free survival (LRFFS), and adverse events.

Start Date01 Nov 2024

Sponsor / Collaborator

First Affiliated Hospital of Guangxi Medical University

NCT06652412 / Not yet recruitingPhase 2IIT

Comprehensive Geriatric Assessment (CGA) Guided Ultrafractionated Radiotherapy and Systemic Treatment in Elderly or Frail Patients with Inoperable Localized Colorectal Cancer

This is a prospective, multicentre, cohort study. For cohort 1, experimental cohort, older or Frail patients with inoperable localized colorectal cancer will receive Ultrafractionated Radiotherapy (RT) and Comprehensive Geriatric Assessment (CGA) Guided systemic treatment. All patients will receive Ultrafractionated RT and PD-1 antibody. Furthermore, CGA will assess all patients and classify them into Frail, Vulnerabe, or Fit. Frail patients will receive Best Supportive Care (BSC); Vulnerabe patients will receive Fluorouracil/Raltitrexed and BSC; Fit patients will receive Fluorouracil/Raltitrexed, Oxaliplatin/Irinotecan, and BSC.
For cohort 2, external control from real word, data of patients with the same baseline characteristics from the same period and the same institute will be prospectively collected.
The primary endpoint is complete response (CR, pathological complete response [pCR] plus clinical complete response [cCR]) rate. The secondary endpoints include the grade 3-4 acute adverse effects rate, anal preservation rate, survival etc.

Start Date01 Nov 2024

Sponsor / Collaborator

Fudan University

NCT06664996 / RecruitingPhase 2IIT

Sintilimab Combined with Stereotactic Body Radiation Therapy As Neoadjuvant Therapy for Resectable Hepatocellular Carcinoma with Branch Portal Vein Tumor Thrombus: a Single-arm, Prospective Clinical Study

The goal of this single-arm, prospective clinical trial is to evaluate the safety and efficacy of neoadjuvant therapy combining sintilimab with stereotactic body radiation therapy (SBRT) in patients with resectable hepatocellular carcinoma (HCC) with branch portal vein tumor thrombus. The main questions it aims to answer are:
1. Is the combination of sintilimab and SBRT safe as neoadjuvant therapy?
2. How effective is this combination in treating resectable HCC with branch PVTT? Participants will be given a combination treatment of sintilimab and SBRT. Researchers will monitor their health conditions to assess the safety and effectiveness of this treatment protocol.

Start Date15 Oct 2024

Sponsor / Collaborator

West China Hospital

100 Clinical Results associated with Sintilimab

100 Translational Medicine associated with Sintilimab

100 Patents (Medical) associated with Sintilimab

2,324

Literatures (Medical) associated with Sintilimab

31 Dec 2024·Oncoimmunology

A phase 2, multicenter, open-label study of anti-LAG-3 ieramilimab in combination with anti-PD-1 spartalizumab in patients with advanced solid malignancies

Article

Author: Lin, Chia-Chi ; Kyi, Chrisann ; Chiu, Joanne ; Askoxylakis, Vasileios ; Carvajal, Richard D ; Spratlin, Jennifer ; Chowdhury, Niladri Roy ; Garralda, Elena ; Gusenleitner, Daniel ; Maur, Michela ; Esaki, Taito ; Siu, Lillian L ; Sarantopoulos, John ; Rolland, Fréderic ; Cassier, Philippe A ; Zhang, Tian ; Soo, Ross A ; Schöffski, Patrick ; Ma, Brigette ; Martin, Miguel ; Deschler-Baier, Barbara ; Weickhardt, Andrew ; De Braud, Filippo ; Hui, Rina ; Akerley, Wallace ; Rispoli, Lawrence ; Hong, David S ; Samant, Tanay S ; Tan, Daniel Sw ; Kwak, Eunice L

Ieramilimab, a humanized anti-LAG-3 monoclonal antibody, was well tolerated in combination with the anti-PD-1 antibody spartalizumab in a phase 1 study. This phase 2 study aimed to further investigate the efficacy and safety of combination treatment in patients with selected advanced (locally advanced or metastatic) solid malignancies. Eligible patients with non-small cell lung cancer (NSCLC), melanoma, renal cell carcinoma (RCC), mesothelioma, and triple-negative breast cancer (TNBC) were grouped depending on prior anti-PD-1/L1 therapy (anti-PD-1/L1 naive or anti-PD-1/L1 pretreated). Patients received ieramilimab (400 mg) followed by spartalizumab (300 mg) every 3 weeks. The primary endpoint was objective response rate (ORR), along with safety, pharmacokinetics, and biomarker assessments. Of 235 patients, 142 were naive to anti-PD-1/L1 and 93 were pretreated with anti-PD-1/L1 antibodies. Durable responses (>24 months) were seen across all indications for patients naive to anti-PD-1/L1 and in melanoma and RCC patients pretreated with anti-PD1/L1. The most frequent study drug-related AEs were pruritus (15.5%), fatigue (10.6%), and rash (10.6%) in patients naive to anti-PD-1/L1 and fatigue (18.3%), rash (14.0%), and nausea (10.8%) in anti-PD-1/L1 pretreated patients. Biomarker assessment indicated higher expression of T-cell-inflamed gene signature at baseline among responding patients. Response to treatment was durable (>24 months) in some patients across all enrolled indications, and safety findings were in accordance with previous and current studies exploring LAG-3/PD-1 blockade.

01 Dec 2024·CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY

Sequencing of systemic therapy in unresectable hepatocellular carcinoma: A systematic review and Bayesian network meta-analysis of randomized clinical trials

Review

Author: Li, Jianjun ; Wang, Haochen ; Cao, Shasha ; Zhang, Yonghong ; Wang, Qi ; Yu, Jianan ; Hu, Caixia ; Li, Jian ; Sun, Xuedong ; Yang, Zeran ; Han, Yanjing ; Jin, Long

PURPOSE:

For patients with advanced or unresectable hepatocellular carcinoma (HCC), safe and effective therapies are urgently needed to improve their long-term prognosis. Although the guidelines recommend first-line treatments such as sorafenib, lenvatinib, and atezolizumab in combination with bevacizumab (T+A) and second-line treatments such as regorafenib, the efficacy comparison between drugs is lacking, that is, a treatment is not recommended as the optimal or alternative choice for a specific patient population. Therefore, we will conduct a high-quality network meta-analysis based on Phase III randomized controlled trials (RCTs) to systematically evaluate and compare overall survival (OS), progression-free survival (PFS), objective response rate (ORR), and serious adverse events (SAE) of different treatment protocols in the context of first-line and second-line therapies, which are critical for clinical decision making and prognostic improvement in advanced HCC patients.

METHODS:

The studies of interest were Phase III RCTs evaluating the efficacy or safety of first- or second-line therapies in patients with unresectable or advanced HCC. Literature published in English from the four databases of PubMed, Embase, Cochrane Library, and Web of Science was comprehensively searched from the inception to May 23, 2022. Outcomes of interest included OS, PFS, ORR, and SAE. A league table was developed to show the results of the comparison between different treatments. A histogram of cumulative probability was drawn to discuss the ranking probability of treatments based on different outcomes. The effectiveness and safety of various treatments were comprehensively considered and the two-dimensional diagram was plotted to guide clinical practice. The Gemtc package in R Studio was used for network meta-analysis in a Bayesian framework.

RESULTS:

The results showed that HAIC-FO was superior to T+A regimen, regardless of OS, PFS or ORR. TACE combined with lenvatinib performed better than T+A in PFS, and ORR. In addition to the T+A regimen, Sintilimab combined with IBI305 and camrelizumab combined with apatinib were also associated with longer OS, PFS, and ORR, and their SAE incidence was not higher than that of T+A, especially for camrelizumab combined with apatinib, its safety was better than that of T+A regimen. There were no new treatments or combinations that were more effective than regorafenib. It was important to note that for PFS, the efficacy of apatinib and cabozantinib was not statistically different from that of regorafenib, so these two treatments could be used as alternative treatment options in cases where regorafenib was not tolerated or treatment failed.

CONCLUSIONS:

We conducted a network meta-analysis to evaluate the efficacy and safety of multiple treatment modalities by integrating the results of direct and indirect comparisons. This study included high-quality multicenter Phase III RCTs, collated and summarized all treatments involved in advanced or unresectable HCC in first-line and second-line settings, and compared with T+A and regorafenib, respectively, and ranked based on efficacy and safety to support clinical decision making.

05 Nov 2024·CHINESE MEDICAL JOURNAL

Neoadjuvant sintilimab and apatinib combined with perioperative FLOT chemotherapy for locally advanced gastric cancer: A prospective, single-arm, phase II study

Article

Author: Zhou, Linyan ; Chen, Shigong ; Zhu, Junmin ; Luo, Changjiang ; Dong, Chi ; Wang, Keshen ; Yu, Zeyuan ; Gu, Qianlin ; Long, Bo ; Jiang, Xiangyan ; Cao, Hongtai ; Gan, Shiying ; Shi, Wengui ; Zhou, Huinian ; Jiao, Zuoyi ; Guan, Xiaoying ; Yang, Hanteng ; Li, Long ; Zhang, Wenjuan ; Zhang, Gengyuan ; Qin, Long ; He, Qichen

462

News (Medical) associated with Sintilimab

08 Oct 2024

·www.prnewswire.com

Innovent and Ask Pharm Announce Strategic Collaboration for Limertinib, a Third-generation EGFR TKI for the Treatment of Lung Cancer

SAN FRANCISCO and SUZHOU, China, Oct. 7, 2024 /PRNewswire/ -- Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of oncologic, autoimmune, cardiovascular and metabolic, ophthalmologic and other major diseases, and Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm, 002755.SZ), announced that the two parties have entered into a strategic collaboration regarding limertinib, a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) for the treatment of lung cancer. Under the agreement, Innovent will obtain the exclusive commercialization rights for limertinib in mainland China, and will be entitled to receive a commercialization service fee based on the product's net sales in the region. Ask-Pharm as the MAH holder, will be responsible for the production and commercial supply of limertinib and will be eligible for upfront, regulatory and sales milestone payments. Limertinib is an orally administrated, third-generation novel EGFR TKI with proprietary rights. Two New Drug Applications (NDAs) for limertinib have been accepted and are under review by China's National Drug Administration (NMPA): (1) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, confirmed by a validated diagnostic test, whose disease has progressed after EGFR TKI therapy; and (2) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. In a multi-center, randomized, double-blind, controlled Phase 3 clinical trial, limertinib's efficacy and safety were compared with gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. The Phase 3 clinical trial met its primary endpoint, and detailed data and analysis will be presented at future academic conferences or published in academic journals. Previously, results of limertinib from a Phase 2b clinical study were presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Dr. Michael Yu, Founder, Chairman and CEO of Innovent, stated: "We are delighted to enter this strategic collaboration with ASK Pharm, one of the most innovative biopharmaceutical companies in China, which will further strengthen Innovent's leadership in oncology. Together with our partners, Innovent has successfully developed a series of high-quality innovative medicines for lung cancer treatments, including TYVYT® (sintilimab Injection), BYVASDA® (bevacizumab Injection), Retsevmo® (selpercatinib), Dupert® (fulzerasib) and Taletrectinib (ROS1 Inhibitor, NDA under review). The addition of limertinib will offer a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer. Innovent remains committed to investing in innovation and collaborative partnerships, aiming to enhancing the accessibility and affordability of innovative therapies in China to benefit even more patients." Mr. Jingfei Ma, Director and General Manager of ASK Pharm, stated: "We are pleased to form a strategic partnership with Innovent Biologics. Oncology is one of the four core areas of focus for ASK Pharm, and our oncology product line spans chemotherapy drugs, small molecule targeted drugs, and biologics. Limertinib, ASK Pharm's first innovative drug, targets the cancer type with the highest incidence and mortality rates in China. Focused on addressing the most common mutations in lung cancer, Ask-Pharm is committed to providing effective drugs for the vast number of patients with EGFR-mutated lung cancer. Innovent has a rich product pipeline in the field of lung cancer, which can form advantageous synergies with limertinib. In addition, with Innovent's professional and efficient marketing team and proven commercialization capabilities, we are confident that this cooperation will help limertinib to fully realize its clinical value, so that more patients can benefit from it." About EGFR mutation-positive non-small-cell lung cancer (NSCLC) Lung cancer is the leading cause of cancer-related death and the second more common cancer worldwide. In China, it has both the highest incidence and mortality rates among malignant tumors. Non-small cell lung cancer (NSCLC) accounts for approximately 80% to 85% of all lung cancers, and approximately 70% of NSCLC patients are diagnosed with locally advanced or metastatic disease that is not eligible to surgical resection. EGFR is the most frequent driver mutation in NSCLC, with 30% to 50% of Asian NSCLC patients having EGFR mutations. EGFR-TKIs are the recommended first-line standard of care for this group, with third-generation EGFR inhibitors offering the broadest applicability. About Limertinib Limertinib is an orally-administrated, third-generation EGFR TKI with proprietary rights, classified as a new molecular entity. Two New Drug Applications (NDAs) of limertinib are currently under review by China's National Drug Administration (NMPA): (1) for the treatment of adult patients with locally advanced or metastatic EGFR T790M mutation-positive NSCLC, confirmed by an approved test, whose disease has progressed following EGFR TKI therapy; and (2) for the first-line treatment of adult patients with locally advanced or metastatic NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations. In a multi-center, randomized, double-blind, controlled Phase 3 clinical trial, the efficacy and safety of limertinib were compared to gefitinib in the first-line treatment of patients with locally advanced or metastatic NSCLC harboring EGFR mutations. The Phase 3 clinical trial met its primary endpoint, and the results will be presented at future academic conferences or published in academic journals. Results from a Phase 2b clinical study were presented in a poster session at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. In October 2024, Innovent and ASK Pharm entered into a strategic collaboration and license agreement regarding limertinib in mainland China. About Innovent Innovent is a leading biopharmaceutical company founded in 2011 with the mission to empower patients worldwide with affordable, high-quality biopharmaceuticals. The company discovers, develops, manufactures and commercializes innovative medicines that target some of the most intractable diseases. Its pioneering therapies treat cancer, cardiovascular and metabolic, autoimmune and eye diseases. Innovent has launched 11 products in the market. It has 5 new drug applications (NDA) under regulatory review, 3 assets in Phase III or pivotal clinical trials and 18 more molecules in early clinical stage. Innovent partners with over 30 global healthcare companies, including Eli Lilly, Sanofi, Incyte, Adimab, LG Chem and MD Anderson Cancer Center. Guided by the motto, "Start with Integrity, Succeed through Action," Innovent maintains the highest standard of industry practices and works collaboratively to advance the biopharmaceutical industry so that first-rate pharmaceutical drugs can become widely accessible. For more information, visit , or follow Innovent on Facebook and LinkedIn. About Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) Founded in January 2003, Jiangsu Aosaikang Pharmaceutical Co. Ltd. (ASK Pharm) is a research-based pharmaceutical enterprise that integrates and streamlines innovative research and development with manufacture, marketing promotion and sales of proprietary pharmaceuticals, fine chemicals and health-care products. ASK Pharm specializes in digestive disease, multidrug resistant infection, oncology and chronic disease areas. ASK Pharm focuses on the R&D of small-molecule targeted innovative drugs and immuno-oncology biologic drugs. Currently, there are 48 major research projects, including 11 disclosed key projects focused on innovative chemical and biologic drugs. Among these, the innovative anti-tumor drug Limertinib are in the NDA stage, while ASKC109 (maltol iron capsules) and ASKB589 (Claudin18.2 monoclonal antibody) are in Phase III clinical trials. ASK Pharm has Ranked among the top 20 best industrial enterprises in China's pharmaceutical R&D pipeline for 14 consecutive years and it has also received numerous honors such as "Top Ten National R&D Innovators", "Best National Enterprise for Investment", and "National Torch Program High-Tech Enterprises". For more information, visit . Innovent's Forward-Looking Statements This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", "intend" and similar expressions, as they relate to Innovent, are intended to identify certain of such forward-looking statements. Innovent does not intend to update these forward-looking statements regularly. These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections and understandings of the management of Innovent with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties and other factors, some of which are beyond Innovent's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Innovent's competitive environment and political, economic, legal and social conditions. Innovent, the Directors and the employees of Innovent assume (a) no obligation to correct or update the forward-looking statements contained in this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turn out to be incorrect. SOURCE Innovent Biologics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2Phase 3License out/inClinical ResultNDA

08 Oct 2024

·www.pharmaceutical-technology.com

Innovent and ASK Pharm to commercialise limertinib for lung cancer

Limertinib is intended for the treatment of patients with lung cancer. Credit: New Africa/Shutterstock. Innovent Biologics and Jiangsu Aosaikang Pharmaceutical (ASK Pharm) have signed a strategic partnership agreement for the commercialisation of limertinib to treat lung cancer. Limertinib is an orally administrated third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI). This collaboration will grant Innovent exclusive rights to commercialise the asset within mainland China, and entitles the company to a service fee based on net sales. ASK Pharm will serve as the marketing authorisation holder and will oversee the manufacturing and commercial distribution of the product. ASK Pharm is entitled to upfront payments and milestone payments contingent on meeting regulatory and sales goals. See Also: Activist investor Starboard forges $1bn stake in Pfizer to swing profits Healthcare Payers for the Pharmaceutical Industry Two new drug applications for limertinib are currently under review by China’s National Medical Products Administration. One application is for an indication to treat adults with locally advanced or metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC), post-EGFR TKI therapy progression. The other is for the first-line treatment of NSCLC with EGFR exon 19 deletions or exon 21 L858R mutations in adults. The efficacy and safety of limertinib were evaluated in a randomised, multicentre, double-blind, controlled Phase III clinical trial comparing it to gefitinib for the first-line treatment of patients with locally advanced or metastatic NSCLC with EGFR mutations. The trial successfully met its primary endpoint, indicating a potential new option for patients with this form of lung cancer. Innovent founder, chairman and CEO Dr Michael Yu stated: “We are delighted to enter this strategic collaboration with ASK Pharm, one of the most innovative biopharmaceutical companies in China, which will further strengthen Innovent’s leadership in oncology. “Together with our partners, Innovent has successfully developed a series of high-quality innovative medicines for lung cancer treatments, including TYVYT (sintilimab Injection), BYVASDA (bevacizumab Injection), Retsevmo (selpercatinib), Dupert (fulzerasib) and Taletrectinib (ROS1 Inhibitor). “The addition of limertinib will offer a valuable new treatment option for Chinese patients with EGFR-mutated lung cancer.” In August 2024, the company’s Kristen rat sarcoma G12C inhibitor, Dupert (fulzerasib), received China’s National Medical Products Administration (NMPA) approval to treat advanced non-small cell lung cancer (NSCLC) in adults.

License out/inPhase 3Drug ApprovalCSCO

23 Sep 2024

·www.globenewswire.com

Elevar Therapeutics Resubmits New Drug Application to FDA for Combination of Camrelizumab plus Rivoceranib as First-Line Treatment Option for Unresectable Hepatocellular Carcinoma Boosted by CARES-310 Leading Overall Survival Analysis

FORT LEE, N.J., Sept. 23, 2024 (GLOBE NEWSWIRE) -- Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd., today announced the resubmission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its investigational drug rivoceranib, an oral VEGF-TKI, in combination with camrelizumab, a PD-1 inhibitor, as a first-line systemic treatment option for unresectable hepatocellular carcinoma (uHCC). In May, the FDA issued a Complete Response Letter (CRL) for the original NDA submitted in May 2023. The CRL cited GMP deficiencies at the Hengrui Pharma facility where camrelizumab is manufactured and incomplete Bioresearch Monitoring (BIMO) clinical inspections due to FDA travel restrictions. The FDA did not indicate any issues related to clinical data or with the manufacturing site for rivoceranib. During a Type A meeting with the FDA in July, the FDA confirmed the responses to observations at the Hengrui manufacturing site were sufficient, resubmission could occur without further delay and BIMO inspections may occur after resubmission. “Elevar’s timely resubmission of the NDA for the combination of camrelizumab and rivoceranib marks a critical milestone in our mission to bring a novel combination therapy for uHCC to patients and healthcare providers. HCC remains an area of significant unmet medical need,” said Dr. Saeho Chong, chief executive officer of Elevar Therapeutics. “This achievement would not have been realized without the extraordinary dedication of Elevar’s teams. We are eager to work with the FDA in the coming months as we focus on the commercialization of our combination therapy.” The resubmission is supported by the Phase 3 CARES-310 study landmark analysis presented during the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting on June 1, which reported median overall survival (mOS) of 23.8 months, the longest mOS for any treatment in a global Phase 3 trial for patients with uHCC, confirming the combination of camrelizumab and rivoceranib continued to show sustained long-term survival as a first-line treatment for uHCC. “The combination of camrelizumab and rivoceranib shows distinct promise as a potential therapy for patients suffering from advanced hepatocellular carcinoma with efficacy results generally consistent across all subgroups,” commented Ahmed Omar Kaseb, M.D., professor, Department of Gastrointestinal Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center in Houston. “The resubmission is strengthened by the recent CARES-310 landmark analysis, which reported the longest median overall survival for any treatment in a global Phase 3 trial in the uHCC setting.” About Hepatocellular Carcinoma Worldwide each year more than 800,000 people are diagnosed with liver canceri and the disease is the cause of more than 830,000 deaths.ii 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. About Rivoceranib Rivoceranib, a small-molecule tyrosine kinase inhibitor (TKI), is a highly potent inhibitor of vascular endothelial growth factor receptor (VEGFR), 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. 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 (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 in gastric cancer (U.S., EU and South Korea), in adenoid cystic carcinoma (U.S.) and in 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. 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 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 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 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab, an anti-PD-1 antibody, for commercialization from Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui Pharma) worldwide excluding Greater China and Korea. Media Contact Jeanette BressiHead, Corporate Communications, Elevar Therapeuticsjbressi@elevartherapeutics.com609-439-3997 Investor Relations Contact Wade SmithChief Financial & Business Officer, Elevar Therapeuticswsmith@elevartherapeutics.com i Key Statistics About Liver Cancer | American Cancer Societyii Key Statistics About Liver Cancer | American Cancer Society

Clinical ResultPhase 3Drug ApprovalOrphan DrugNDA

100 Deals associated with Sintilimab

External Link

KEGG	Wiki	ATC	Drug Bank
-	Sintilimab	L01XC	DB15765

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Classical Hodgkin's Lymphoma	MO	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2024
Gastroesophageal junction adenocarcinoma	MO	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2024
Non-Small Cell Lung Cancer	MO	Innovent Biologics (Suzhou) Co. Ltd.	22 Feb 2024
EGFR positive Non-squamous non-small cell lung cancer	CN	Innovent Biologics (Suzhou) Co. Ltd.	09 May 2023
Stomach Cancer	CN	Innovent Biologics (Suzhou) Co. Ltd.	24 Jun 2022
Esophageal Squamous Cell Carcinoma	CN	Innovent Biologics, Inc.	20 Jun 2022
Hepatocellular Carcinoma	CN	Innovent Biologics (Suzhou) Co. Ltd.	28 Jun 2021
Hodgkin's Lymphoma	CN	Innovent Biologics (Suzhou) Co. Ltd.	24 Dec 2018

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced Endometrial Carcinoma	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	02 Apr 2024
Non-squamous non-small cell lung cancer	NDA/BLA	US	Innovent Biologics (Suzhou) Co. Ltd.	11 Feb 2022
EGFR T790M Mutation Positive Non-Small Cell Lung Carcinoma	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	30 Jan 2022
Esophageal Carcinoma	NDA/BLA	CN	Innovent Biologics (Suzhou) Co. Ltd.	22 Sep 2021
Colorectal Cancer	Phase 3	-	Shenzhen Chipscreen Biosciences Co., Ltd.	30 Sep 2024
Small Cell Lung Cancer	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	07 Mar 2024
Locally Advanced Esophageal Squamous Cell Carcinoma	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	01 Nov 2022
Advanced Renal Cell Carcinoma	Phase 3	CN	Hutchison MediPharma Ltd.	27 Oct 2022
Locally Advanced Renal Cell Carcinoma	Phase 3	CN	Hutchison MediPharma Ltd.	27 Oct 2022
Metastatic Gastroesophageal Junction Adenocarcinoma	Phase 3	CN	Innovent Biologics (Suzhou) Co. Ltd.	10 Mar 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05017103 (CTgov)	Phase 2	Malignant Fibrous Histiocytoma	6	sintilimab	cfuvmytflm(zmcwjtaqfg) = wnczqqazgn npyneinfki (jcyjhxrxbo, unmjgxjczw - qlbkglorjk) View more	-	12 Nov 2024
NCT05400070 (TD-NeoFOUR, Pubmed) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	45	Sintilimab+Anlotinib+Chemotherapy (ITT)	faydzplvyp(bdqagpdkzi) = nvmacspftj styetxspri (sporkwfihs ) View more	Positive	28 Oct 2024
NCT05400070 (TD-NeoFOUR, Pubmed) Manual	Phase 2	Resectable Lung Non-Small Cell Carcinoma Neoadjuvant	45	Sintilimab+Anlotinib+Chemotherapy (per-protocol set)	faydzplvyp(bdqagpdkzi) = pucwzeceww styetxspri (sporkwfihs ) View more	Positive	28 Oct 2024
NEWS Manual	Phase 2	Primary Central Nervous System Lymphoma	27	信迪利单抗+甲氨蝶呤+替莫唑胺+利妥昔单抗	atkhkwsmhg(uzmsukvhjz) = pqbzjaldfx gxgqjyozvx (czjqniobtl ) View more	Positive	19 Sep 2024
NCT05753163 (ESMO2024) Manual	Phase 2	colon cancer liver metastasis Adjuvant	35	sintilimab+regorafenib	qpwufydfuf(ykdadnmvig) = gsyzxpvqxc fymkdafvcn (yvqckmhzag ) View more	Positive	16 Sep 2024
NCT05616390 (ESMO2024) Manual	Phase 2	Unresectable Hepatocellular Carcinoma	24	FOLOFOX-HAIC + Sintilimab + IBI305	fhyiqhbpzo(sczruhembe) = zarkekhzbd chygbjvcvd (hzjfyniqzd ) View more	Positive	16 Sep 2024
ChiCTR2100055071 (SINANLOSARC, ESMO2024) Manual	Phase 2	Sarcoma Second line	42	Sintilimab+anlotinib	yvhmkekkxw(sahjybussh) = mutnzbaqut yyrkqmvuba (iswjkzzatx, 19.07 - 46.03) View more	Positive	14 Sep 2024
WCLC2024 Manual	Phase 2	Neoplasms First line	30	Sintilimab plus gemcitabine and carboplatin	vmsoiqrvhb(kpmnoumhhs) = uxlmsrttpa ntqwbfkkij (dnyewgvsoi, 54.1 - 87.7) View more	Positive	10 Sep 2024
ChiCTR2000032266 (WCLC2024) Manual	Early Phase 1	KRAS mutant Non-small Cell Lung Cancer Second line KRAS mutation \| KRAS G12C mutations \| non-G12C subtypes	30	Sintilimab	zkxvnopmhh(xihhcbtsjt) = vohetkbbry vfxzmplogn (ymzzdhltel, 3.3 - 11.5) View more	Positive	09 Sep 2024
NCT04326153 (WCLC2024) Manual	Phase 2	Non-small cell lung cancer stage III Neoadjuvant ctDNA-MRD	30	Neoadjuvant chemoimmunotherapy (sintilimab combined with nab-paclitaxel and carboplatin)	jjupqlmbdk(hdbkhbcfuh) = napyyaywkk ogielnjqri (cwtswelnlb ) View more	Positive	07 Sep 2024
NCT04304209 (Pubmed) Manual	Phase 2	Locally Advanced Rectal Carcinoma Proficient DNA Mismatch Repair (pMMR)	134	NACRT	xcolpqxufr(hgbqbgwyuo) = etcoutuiar hnelfsxjem (ycrpdykdjn, 16.0 - 37.8)	Positive	24 Jul 2024
NCT04304209 (Pubmed) Manual	Phase 2		134	NACRT + PD-1 antibody sintilimab	xcolpqxufr(hgbqbgwyuo) = ucwnyqgfgu hnelfsxjem (ycrpdykdjn, 32.6 - 57.0)	Positive	24 Jul 2024

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