CARsgen's Satri-cel Abstract Available on ASCO Website

Core Viewpoint - CARsgen Therapeutics announced the availability of research results from a confirmatory Phase II clinical trial of satricabtagene autoleucel ("satri-cel") for advanced gastric/gastroesophageal junction cancer, highlighting its potential as a new standard of care in this indication [1][9]. Group 1: Clinical Trial Overview - The Phase II trial (CT041-ST-01) was a multicenter, randomized controlled trial conducted in China, comparing satri-cel to standard of care in patients with CLDN18.2 positive advanced G/GEJC who had failed at least two prior treatments [2][4]. - The primary endpoint was progression-free survival (PFS) assessed by an Independent Review Committee (IRC), with overall survival (OS) as a key secondary endpoint [2][4]. Group 2: Patient Demographics and Treatment - A total of 156 patients were randomized (2:1) to receive either satri-cel (n=104) or treatment of physician's choice (TPC) (n=52), with a median of 2 prior systemic therapies in both arms [3][4]. - In the TPC arm, patients could receive subsequent satri-cel if they experienced disease progression or drug intolerance [3]. Group 3: Efficacy Results - In the intention-to-treat (ITT) population, the satri-cel arm showed a median PFS of 3.25 months compared to 1.77 months in the TPC arm, representing a 63% reduction in the risk of disease progression or death [5]. - The median OS for the satri-cel arm was 7.92 months versus 5.49 months for the TPC arm, indicating over a 30% reduction in mortality risk [5]. Group 4: Treatment Benefits in mITT Population - In the modified intention-to-treat (mITT) population, the median PFS was 4.37 months for satri-cel versus 1.84 months for TPC, showing a 70% reduction in risk of disease progression or death [6]. - The median OS in the mITT population was 8.61 months for satri-cel compared to 5.49 months for TPC, corresponding to a 40% reduction in mortality risk [6]. Group 5: Safety Profile - Satri-cel demonstrated a favorable safety profile, with only 4 cases of Grade 3 cytokine release syndrome (CRS) reported and no Grade 4-5 CRS events observed [8]. - No immune effector cell-associated neurotoxicity syndrome (ICANS) was reported [8]. Group 6: Significance of Findings - This trial represents the first confirmatory randomized controlled trial of CAR-T therapy in solid tumors, demonstrating significant PFS improvement and clinically meaningful OS benefits for patients with advanced G/GEJC [9]. - The results support the potential of satri-cel as a new standard of care for this patient population [9]. Group 7: About Satri-cel - Satri-cel is an autologous CAR T-cell product candidate targeting Claudin18.2, with ongoing trials for various indications including advanced gastric/gastroesophageal junction cancer and pancreatic cancer [10]. - The product has received Breakthrough Therapy Designation in China and Regenerative Medicine Advanced Therapy designation from the U.S. FDA, indicating its potential significance in treating advanced G/GEJC [10]. Group 8: About CARsgen Therapeutics - CARsgen Therapeutics is focused on developing innovative CAR T-cell therapies to address unmet clinical needs across various malignancies and diseases [11]. - The company has established comprehensive capabilities for CAR T-cell research and development, aiming to enhance safety and efficacy while reducing treatment costs [11].