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Associated Press
4 days ago
- Business
- Associated Press
CARsgen Presents Research Results on Satri-cel in The Lancet and at the 2025 ASCO Annual Meeting
SHANGHAI, June 1, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: a company focused on developing innovative CAR T-cell therapies, announces that the results of the pivotal Phase II clinical trial in China (CT041-ST-01, NCT04581473) investigating satricabtagene autoleucel ('satri-cel', CT041) (a Claudin18.2-specific autologous CAR T-cell product candidate) in patients with Claudin18.2-positive, advanced gastric/gastroesophageal junction cancer refractory to at least two prior lines of treatment, have been published in The Lancet and were orally presented at the 2025 ASCO Annual Meeting. Further details have been posted on the corporate website The article in The Lancet was titled 'Claudin-18 isoform 2-specific CAR T-cell therapy (satri-cel) versus treatment of physician's choice for previously treated advanced gastric or gastro-oesophageal junction cancer (CT041-ST-01): a randomised, open-label, phase 2 trial'. Full article available at: The oral presentation at the 2025 ASCO Annual Meeting (Abstract 4003) was titled 'Claudin18.2-specific CAR T cells (Satri-cel) versus treatment of physician's choice (TPC) for previously treated advanced gastric or gastroesophageal junction cancer (G/GEJC): Primary results from a randomized, open-label, phase II trial (CT041-ST-01)'. Professor Lin Shen from Beijing Cancer Hospital, the principal investigator of this study, said, 'The CT041-ST-01 trial represents the world's first randomized controlled clinical study of CAR-T cell therapy for solid tumors. In patients with heavily pretreated, advanced gastric/gastroesophageal junction cancer who have extremely limited treatment options and poor prognosis, satri-cel has demonstrated breakthrough efficacy with significant clinical benefits, including much improved progression-free survival (PFS), overall survival (OS), and tumor response rates. This brings new hope to patients with otherwise medically untreatable conditions. We are further exploring satri-cel's potential in adjuvant settings and as first-line sequential therapies, aiming to intervene earlier in the disease course, extend patients' survival, and ultimately pursue potential cures.' Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics, said, 'We are honored that the CT041-ST-01 study results were published in The Lancet—a premier, global medical journal—and presented at the 2025 ASCO Annual Meeting. The positive result of this randomized controlled trial marks a major milestone in solid tumor CAR-T therapy. These achievements are a testament to the whole research team's years of dedication, and we extend our deepest gratitude to patients and their families for their trust and participation. This year, satri-cel has been granted Breakthrough Therapy Designation and Priority Review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced gastric/gastroesophageal junction adenocarcinoma (G/GEJA) in patients who have failed at least two prior lines of therapy. We plan to submit a New Drug Application (NDA) for satri-cel to the NMPA this month and anticipate its approval as the world's first commercially available CAR-T product for solid tumors, bringing benefits to patients.' About Satri-cel Satri-cel is an autologous CAR T-cell product candidate against the protein Claudin18.2 that has the potential to be the first-in-class globally. Satri-cel targets the treatment of Claudin18.2-positive solid tumors with a primary focus on G/GEJA and pancreatic cancer (PC). Initiated trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced G/GEJA in China (CT041-ST-01, NCT04581473), a Phase Ib clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), an investigator-initiated trial for satri-cel be used as consolidation treatment following adjuvant therapy in patients with resected G/GEJA (CT041-CG4010, NCT06857786), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel has been granted Priority Review by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in May 2025. Satri-cel has been granted Breakthrough Therapy Designation by the CDE of China's NMPA for the treatment of Claudin18.2-positive advanced G/GEJA in patients who have failed at least two prior lines of therapy in March 2025. Satri-cel was granted Regenerative Medicine Advanced Therapy designation by U.S. FDA for the treatment of advanced G/GEJA with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in September 2020 for the treatment of G/GEJA. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company focusing on developing innovative CAR T-cell therapies to address the unmet clinical needs including but not limited to hematologic malignancies, solid tumors and autoimmune diseases. CARsgen has established end-to-end capabilities for CAR T-cell research and development covering target discovery, preclinical research, product clinical development, and commercial-scale production. CARsgen has developed novel in-house technologies and a product pipeline with global rights to address challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs, etc. CARsgen's mission is to be a global biopharmaceutical leader that provides innovative and differentiated cell therapies for patients worldwide and makes cancer and other diseases curable. Forward-looking Statements All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group's current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group's control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading 'Principal Risks and Uncertainties' in our most recent annual report and interim report and other announcements and reports made available on our corporate website, No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release. Contact CARsgen For more information, please visit View original content to download multimedia: SOURCE CARsgen Therapeutics
Medscape
5 days ago
- Business
- Medscape
CAR T-Cell Therapy Boosts PFS in Advanced Gastric Cancer
In patients with advanced Claudin-18 isoform 2 (CLDN18.2) -positive gastric or gastroesophageal junction cancers, satricabtagene autoleucel (satri-cel) chimeric antigen receptor (CAR) T-cell therapy significantly extended progression-free survival (PFS) compared with treatment of physician's choice (TPC). METHODOLOGY CLDN18.2, a tight-junction protein, is overexpressed in patients with gastric and gastroesophageal junction (GEJ) cancers. Satri-cel, an autologous CLDN18.2-specific CAR T-cell therapy, showed promise in previously treated patients with advanced disease, but further validation is needed. The new phase 2 randomized controlled trial involved 156 patients with pathologically confirmed CLDN18.2-positive advanced gastric or GEJ cancer who were refractory to two or more previous lines of treatment. The study was conducted in multiple centers in China, and the median age of participants was 52 years. Participants were randomly assigned in a 2:1 ratio to receive either satri-cel (IV infusion, up to three times at 250 × 10 6 cells; n = 104) or TPC (n = 52) that included nivolumab, paclitaxel, docetaxel, irinotecan, or rivoceranib. cells; n = 104) or TPC (n = 52) that included nivolumab, paclitaxel, docetaxel, irinotecan, or rivoceranib. In the satri-cel group, 85% of patients received at least one infusion of satri-cel, 31% received a second infusion, and 6% received a third infusion. In the TPC group, 92% of patients received at least one dose of their treatment. The primary endpoint was PFS assessed by a blinded independent review committee. The key secondary endpoint was overall survival (OS). The median follow-up time for PFS was 9.07 months in the satri-cel group and 3.45 months in the TPC group. The median follow-up time for OS was 14.42 months and 11.33 months in the satri-cel and TPC groups, respectively. TAKEAWAY In the intention-to-treat population, the median PFS was 3.25 months in the satri-cel group and 1.77 months in the TPC group. Satri-cel reduced the risk for progression or death by 63% (hazard ratio [HR], 0.37; P < .0001). Median OS showed improvement with satri-cel vs TPC (7.92 vs 5.49 months), although it did not reach statistical significance (HR, 0.69; P = .0416). < .0001). Median OS showed improvement with satri-cel vs TPC (7.92 vs 5.49 months), although it did not reach statistical significance (HR, 0.69; = .0416). The objective response rate was notably higher in the satri-cel group than in the TPC group (22% vs 4%), with disease control rates of 63% and 25%, respectively. The median duration of response was 5.52 months in the satri-cel group. Only two patients in the TPC group showed a partial response, with durations of 4.47 months and 5.42 months, respectively. The median duration of disease control was 3.61 months and 4.27 months in the satri-cel and TPC groups, respectively. All patients in the satri-cel group experienced treatment-emergent adverse events compared with 92% in the TPC group. Grade 3 or higher adverse events occurred in 99% of patients in the satri-cel group and 63% of those in the TPC group; the most common ones were decreased lymphocyte count (99%), decreased white blood cell count (98%), and cytokine release syndrome (95%). IN PRACTICE In this randomized, phase 2 study, "satri-cel was associated with a statistically significant increase in progression-free survival and clinically meaningful increase in overall survival compared with TPC, along with a manageable safety profile in patients with previously treated, advanced, CLDN18.2-positive gastric or gastroesophageal junction cancer," the authors write. SOURCE The study, led by Changsong Qi, MD, Beijing Key Laboratory of Cell & Gene Therapy for Solid Tumour, State Key Laboratory of Holistic Integrative Management of Gastrointestinal Cancers, Department of Early Drug Development Centre, Peking University Cancer Hospital & Institute in Beijing, China, was published online May 31 in The Lancet . LIMITATIONS The sample size — powered for PFS — might be insufficient to yield definitive conclusions from the subgroup analyses. Some patients in the satri-cel group could not receive CAR T-cell infusion after apheresis, making them ineligible for treatment. The time between apheresis and CAR T-cell infusion remains a significant limiting factor, particularly in the case of those experiencing rapid disease progression. DISCLOSURES The study was funded by CARsgen Therapeutics, the National Key Research and Development Program of China, the National Natural Science Foundation of China, Beijing Hospitals Authority Youth Programme, Science Foundation of Peking University Cancer Hospital, Clinical Medicine Plus X—Young Scholars Project of Peking University, and the Peking University Clinical Scientist Training Program. Five authors declared being employees of CARsgen Therapeutics. The other authors declared no competing interests.
