Le Lézard
Classified in: Health
Subject: TRI

First patient dosed in Phase III GEMSTONE-303 study for CS1001 in combination with chemotherapy in first-line gastric adenocarcinoma and gastro-esophageal junction adenocarcinoma


SHANGHAI, April 16, 2019 /PRNewswire/ -- CStone Pharmaceuticals (the "Company" or "CStone"; HKEX: 2616) announces that the first patient has been successfully enrolled and dosed in a Phase III clinical trial assessing CS1001, China's first fully human, full-length anti-PD-L1 antibody, in combination with chemotherapy for the treatment of gastric adenocarcinoma (GC) or gastro-esophageal junction (GEJ) adenocarcinoma. The multi-center, placebo-controlled clinical trial GEMSTONE-303 will evaluate efficacy and safety of CS1001 plus oxaliplatin and capecitabine (XELOX) chemotherapy as first-line treatment in patients with unresectable, locally advanced, or metastatic gastric adenocarcinoma or GEJ adenocarcinoma.

According to data from Chinese National Cancer Center, gastric cancer is the second most common cause of cancer-related death after lung cancer. In 2015, gastric cancer accounted for approximately 679,100 new cancer cases in China, and approximately 498,000 patients died from the disease. Gastric adenocarcinoma comprises in excess of 90% of malignant neoplasms of the stomach, while incidence of GEJ has been rising in recent years. Currently, chemotherapy is still the primary treatment option for both gastric adenocarcinoma and GEJ, while the only available biologic drug therapy for the indication is restricted to HER2-positive cases, which make up only 12% to 13% of total patient numbers.

"We are pleased to get this Phase III clinical study under way with the first patient enrolled and dosed," Dr. Frank Jiang, Chairman and CEO of CStone, commented. "For the past few decades, gastric cancer incidence rate and mortality rate have decreased in most areas of the world. However, in China the number of cases of gastric cancer keeps increasing and both gastric adenocarcinoma and GEJ still represent major healthcare problems with serious unmet medical needs. We hope CS1001 can prove successful in this registration study and provide an important new treatment option for Chinese patients."

Dr. Jason Yang, CStone's Chief Medical Officer, commented: "Around 40%-60% of patients with gastric adenocarcinoma are diagnosed at the advanced stage, for which treatment options are limited. Current clinical studies have shown that anti-PD-1/PD-L1 drugs when paired with chemotherapy are highly efficacious in multiple cancer types including gastric cancer. We expect that CS1001 in combination with oxaliplatin and capecitabine will generate significantly better efficacy than chemotherapy alone in patients with gastric cancer."

About CS1001

CS1001 is an investigational monoclonal antibody directed against PD-L1 being developed by CStone. Authorized by the U.S.-based Ligand Corporation, CS1001 is developed by the OMT transgenic animal platform, which can generate fully human antibodies in one step. As a fully human, full-length anti-PD-L1 monoclonal antibody, CS1001 mirrors natural G-type immune globulin 4 (IgG4) human antibody, which can reduce the risk of immunogenicity and potential toxicities in patients, potentially representing a unique advantage over similar drugs.

CS1001 has completed a Phase I dose-escalation study in China, in which CS1001 showed good tolerance and produced sustained clinical benefit during the Phase Ia stage of the study. In addition, two pivotal Phase II studies and three Phase III studies have been initiated in China.

About CStone

CStone Pharmaceuticals (HKEX: 2616) is a biopharmaceutical company focused on developing and commercializing innovative immuno-oncology and precision medicine to address the unmet medical needs of cancer patients in China and worldwide. Established in 2015, CStone has assembled a world-class management team with extensive experience in innovative drug development, clinical research, and commercialization. The company has built an oncology-focused pipeline with a strategic emphasis on immune-oncology combination therapies. Currently, 4 late-stage candidates are at or near pivotal trials. With an experienced team, a rich pipeline, a robust clinical development-driven business model, and substantial funding, CStone's vision is to become globally recognized as a leading Chinese biopharmaceutical company by bringing innovative oncology therapies to cancer patients worldwide.

For more information about CStone Pharmaceuticals, please visit: www.cstonepharma.com.

Forward-looking Statement

The forward-looking statements made in this article relate only to the events or information as of the date on which the statements are made in this article. Except as required by law, we undertake no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events. You should read this article completely and with the understanding that our actual future results or performance may be materially different from what we expect. In this article, statements of, or references to, our intentions or those of any of our Directors or our Company are made as of the date of this article. Any of these intentions may alter in light of future development.

SOURCE CStone Pharmaceuticals


These press releases may also interest you

at 10:05
The "Distribution Deals in Diagnostics 2016 to 2024" report has been added to ResearchAndMarkets.com's offering. Distribution Deals in Diagnostics provides a detailed understanding and analysis of how and why companies enter distribution deals....

at 10:00
Driving is the leading cause of work-related death each year in the United States, with nearly 40% of deaths on the job occurring on American roads according to the U.S. Bureau of Labor Statistics. A major contributing factor to road deaths each...

at 10:00
Upsher-Smith Laboratories, LLC (Upsher-Smith) today announced the recent launch of Methimazole Tablets, USP, 5 mg and 10 mg. The Methimazole Tablet market had U.S. sales of approximately $36.8 million for the 12 months ending December 2023 according...

at 10:00
NastLaw LLC announces: If you purchased certain named generic pharmaceutical drugs directly from certain pharmaceutical manufacturers from May 1, 2009 through December 31, 2019, your rights may be affected by proposed class action settlements.A...

at 09:48
Perspire Sauna Studio, one of the country's largest sauna franchises specializing in full spectrum infrared (IR) and red-light therapy (RLT), is rolling out a new sauna design and member experience through the brand's long-standing partnership with...

at 09:38
The Kinetix Group (TKG) and Pfizer Inflammation and Immunology received a PM360 Pharma Choice Award for their recent health equity initiative. The award recognized Pfizer's atopic dermatitis interactive guide for varying skin tones....



News published on and distributed by: