Esophageal Squamous Cell Carcinoma

This approval marks the second international marketing authorization for sugemalimab outside of China, following its recent approval by the European Commission. The approval is based on results from the Phase 3 GEMSTONE-302 clinical trial, which demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) in treatment-naive patients with metastatic NSCLC. Long-term survival data from the GEMSTONE-302 study were presented at the 2024 European Society for Medical Oncology (ESMO) Annual Meeting. CStone is actively communicating with regulatory authorities, including the European Medicines Agency (EMA) for marketing authorization applications for additional indications of sugemalimab. CStone has entered into a strategic commercialization partnership with Ewopharma for sugemalimab in Central & Eastern Europe and Switzerland, with further collaborations expected soon in regions including Western Europe, Latin America, the Middle East, and Southeast Asia. SUZHOU, China, Oct. 31, 2024 /PRNewswire/ -- CStone Pharmaceuticals (HKEX: 2616), an innovation-driven biopharmaceutical company focused on the research and development of anti-cancer therapies, today announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved sugemalimab in combination with platinum-based chemotherapy as a first-line treatment for adult patients with metastatic non-small cell lung cancer (NSCLC) without EGFR-sensitive mutations or ALK, ROS1, RET genomic alterations. This marks the second overseas approval for sugemalimab following its recent authorization by the European Commission. Dr. Jason Yang, CEO, President of R&D and Executive Director of the Board at CStone, said, "This approval is a significant milestone in our global expansion strategy. Sugemalimab is the first domestic anti-PD-L1 antibody to receive approval outside of China and has already entered the world's second-largest pharmaceutical market, the EU. Now, with the UK approval, sugemalimab continued to expand its presence in the European market. The long-term survival data, recently presented at this year's ESMO Congress, further confirmed sugemalimab's value in the frontline treatment landscape for metastatic NSCLC." Dr. Yang added, "We are actively pursuing additional partnerships across Western Europe, Latin America, the Middle East, Southeast Asia, and Canada, and expect to finalize some of these agreements shortly. Meanwhile, we are communicating with the European Medicines Agency (EMA) and other agencies for additional regulatory applications for other sugemalimab indications, including Stage III NSCLC, first-line gastric cancer, and first-line esophageal squamous cell carcinoma, aiming to bring innovative treatment options to more patients globally." The MHRA's approval is primarily based on the data from GEMSTONE-302, a multicenter, randomized, double-blind phase 3 trial. The study demonstrated that sugemalimab in combination with chemotherapy significantly prolonged progression-free survival (PFS) and overall survival (OS) compared to placebo combined with chemotherapy in treatment-naïve patients with metastatic NSCLC. Study results have been published in The Lancet Oncology and Nature Cancer, and have been presented at multiple international academic conferences in both oral and poster sessions. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

BeiGene’s Tevimbra (tislelizumab) has been recommended by the European Medicines Agency’s human medicines committee as a first-line treatment for gastric and oesophageal cancer patients. The Committee for Medicinal Products for Human Use (CHMP) has recommended that the PD-1 inhibitor be used in combination with platinum- and fluoropyrimidine-based chemotherapy to treat adults with HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma, and in combination with platinum-based chemotherapy to treat adults with unresectable, locally advanced or metastatic oesophageal squamous cell carcinoma (ESCC). Those eligible for the drug will also have tumours that express PD-L1 with a tumour area positivity (TAP) score of at least 5%, according to the recommendations. Gastric cancer is the fifth leading cause of cancer-related deaths globally, while oesophageal cancer is the sixth. Tevimbra is already approved in the EU for certain cases of advanced or metastatic ESCC after prior platinum-based chemotherapy, and for three non-small cell lung cancer indications covering both the first- and second-line settings. The CHMP’s decision for Tevimbra in G/GEJ cancer was based on positive results from the late-stage RATIONALE-305 trial, in which BeiGene’s drug in combination with investigator’s choice of chemotherapy resulted in a 20% reduction in the risk of death compared to placebo plus chemotherapy in patients with advanced unresectable or metastatic G/GEJ cancer. This benefit rose for patients expressing PD-L1 with a TAP score of at least 5%, with Tevimbra-chemotherapy demonstrating a 29% reduction in the risk of death compared to the placebo arm in this population. The committee’s recommendation in ESCC was supported by results from the phase 3 RATIONALE-306, which showed a 34% reduction in the risk of death for Tevimbra in combination chemotherapy versus placebo plus chemotherapy for patients unresectable, locally advanced recurrent or metastatic ESCC. Three-year overall survival in patients expressing PD-L1 with a TAP score of at least 5% was also substantially improved in favour of the Tevimbra arm, demonstrating a 38% reduction in the risk of death. Mark Lanasa, chief medical officer, solid tumours at BeiGene, said: “With these CHMP opinions, we are one step closer to bringing this innovative therapy to eligible patients with untreated G/GEJ cancer and ESCC, who face a poor prognosis and limited treatment options.” The European Commission will now consider the CHMP’s recommendations as it makes a final decision on Tevimbra in these indications.

National Cancer Institute Phase II STTR funding will further the development of a non-endoscopic diagnostic for the detection of esophageal cancer in the US and East Africa. BALTIMORE, Oct. 22, 2024 /PRNewswire/ -- Previse, maker of Esopredict, a clinically available epigenetic test to assess the risk of esophageal cancer developing in patients with Barrett's esophagus was awarded a prestigious and highly competitive $1.8M STTR (Small Business Technology Transfer) grant by the National Cancer Institute (NCI) of the National Institutes of Health (NIH). The grant will further support Previse's collaboration with investigators at the Johns Hopkins University School of Medicine and clinical sites in East Africa. The funding will accelerate the development of a non-endoscopic screening test for esophageal squamous cell carcinoma (ESCC), a highly lethal form of esophageal cancer. The funds will also underpin early commercialization efforts in the U.S. and establish a commercialization pathway in East Africa, ensuring global access to accurate, affordable, and practical ESCC detection. Previse CEO Daniel Lunz said: "ESCC accounts for >80% of esophageal cancer deaths worldwide, including one-third of esophageal cancer cases occurring in the United States. Asian and Black populations are disproportionately affected by ESCC, representing a significant unmet need from a global public health perspective. These funds will advance this critically needed research, with the goal of bringing a highly effective and affordable non-endoscopic solution to market to expand access to earlier detection in the US and worldwide." About Previse and Esopredict Established in 2018, Previse is a gastrointestinal health company with a primary focus on chronic acid reflux related diseases, including esophageal cancer. Previse's mission is to save lives and improve patient health through prevention and early detection. Previse leverages groundbreaking biomarker technology developed by Stephen Meltzer, M.D., and his GI Early Detection Biomarker Lab at the Johns Hopkins University School of Medicine. This technology, backed by funding from the National Institutes of Health (NIH) and decades of research, forms the foundation of Previse's commitment to combating GI diseases, including cancer. At the forefront is Esopredict, a highly sensitive DNA methylation-based test designed to predict the risk of progression to high-grade dysplasia or esophageal adenocarcinoma in patients with precancerous Barrett's esophagus. With a turnaround time of about two weeks after a sample is received, Esopredict empowers gastroenterologists to tailor effective treatment strategies, marking a pivotal advancement in the battle against esophageal cancer. For additional information about Esopredict and full study details, please visit . SOURCE Previse WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED