Satricabtagene autoleucel

SHANGHAI, Dec. 30, 2024 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces the positive results from the pivotal Phase II clinical trial CT041-ST-01(NCT04581473). This study is an open-label, multicenter clinical trial evaluating the safety and efficacy of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against Claudin18.2) in subjects with Claudin18.2 expression-positive, advanced gastric/gastroesophageal junction cancers that have failed at least 2 prior lines therapy. Patients were 2:1 randomly assigned to receive treatment of satricabtagene autoleucel infusion or treatment of physician's choice (including paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). The primary endpoint of the trial is progression-free survival (PFS) assessed by the Independent Review Committee (IRC). The study met its primary endpoint of a statistically significant improvement in PFS assessed by IRC for patients treated with satri-cel infusion as compared to treatment of physician's choice (paclitaxel, docetaxel, irinotecan, apatinib, or nivolumab). Previous data demonstrates that the safety profile of satricabtagene autoleucel was manageable. "We are thrilled to see that satri-cel has achieved positive results in the pivotal Phase II clinical trial in China. The study demonstrates that satri-cel provides significant benefits to gastric cancer patients who have failed at least two prior lines of therapy. This represents a groundbreaking milestone for the field of CAR-T therapies against solid tumors. We anticipate submitting an NDA to the NMPA in the first half of 2025 and look forward to satri-cel becoming the world's first CAR-T product for solid tumors, bringing hope to more patients as soon as possible. Additionally, we will continue to explore the potential of satri-cel in adjuvant therapy for gastric and pancreatic cancers, aiming to deliver even greater benefits to patients," said Dr. Zonghai Li, Founder, Chairman of the Board, Chief Executive Officer, and Chief Scientific Officer of CARsgen Therapeutics. 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 gastric cancer/gastroesophageal junction cancer (GC/GEJ) and pancreatic cancer (PC). Ongoing trials include investigator-initiated trials (CT041-CG4006, NCT03874897), a confirmatory Phase II clinical trial for advanced gastric/gastroesophageal junction cancer in China (CT041-ST-01, NCT04581473), a Phase I clinical trial for PC adjuvant therapy in China (CT041-ST-05, NCT05911217), and a Phase 1b/2 clinical trial for advanced gastric or pancreatic adenocarcinoma in North America (CT041-ST-02, NCT04404595). Satri-cel was granted Regenerative Medicine Advanced Therapy (RMAT) designation by U.S. FDA for the treatment of advanced GC/GEJ with Claudin18.2-positive tumors in January 2022. Satri-cel received Orphan Drug designation from the U.S. FDA in 2020 for the treatment of GC/GEJ. About CARsgen Therapeutics Holdings Limited CARsgen is a biopharmaceutical company with operations in China and the U.S., focusing on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform that covers target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. Internally, CARsgen has developed novel technologies and a product pipeline with global rights to address significant challenges faced by existing CAR T-cell therapies. Efforts include improving safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen's mission is to become a global biopharmaceutical leader that provides innovative and differentiated cell therapies for cancer patients worldwide and makes cancer 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. 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78-Week results from Phase III randomized controlled trial (RCT) including switching data from reference denosumab to CT-P41 (biosimilar candidate of denosumab) demonstrate comparable efficacy and safety results; Results support the therapeutic equivalence of CT-P41 and reference denosumab in treating postmenopausal women with osteoporosis (PMO)[1] Data from the Phase III RCT showed comparable and sustained efficacy, safety and immunogenicity profile to the reference tocilizumab in patients with active moderate-to-severe rheumatoid arthritis (RA) over 1-year after single transition from Week 24[2] JERSEY CITY, N.J., Nov. 18, 2024 /PRNewswire/ -- Celltrion today presented additional data from a Phase III randomized controlled trial (RCT) for CT-P41, a biosimilar candidate referencing PROLIA®/XGEVA® (denosumab) in postmenopausal women with osteoporosis (PMO) and a Phase III RCT for CT-P47, a biosimilar candidate referencing ACTEMRA® (tocilizumab) in patients with moderate-to-severe active rheumatoid arthritis (RA) at the American College of Rheumatology (ACR) Convergence 2024 in Washington, D.C. The additional efficacy and safety results from Week 52 to Week 78 including switching data from reference denosumab to the CT-P41 (Treatment Period [TP] II) showed comparable and sustained efficacy results to reference denosumab in treating women with PMO after the single transition from reference denosumab to CT-P41. CT-P41 was well tolerated with a safety profile comparable to reference denosumab, and no notable safety issue was identified following the single transition compared with maintenance groups up to Week 78. The results further support the biosimilarity between CT-P41 and reference denosumab in treating women with PMO.[1] In addition, post-hoc impact analysis using data from the Phase III RCT was conducted to determine any correlation between immunogenicity and clinical outcomes in PMO between the treatment groups. According to the results, the impact of anti-drug antibody (ADA) on pharmacokinetics (PK), efficacy and safety and the treatment emergent adverse events (TEAE) incidences were comparable between the treatment groups in the ADA status groups.[3] Despite the high ADA incidence compared to the reference denosumab historical studies,[4] it can be suggested that ADA to CT-P41 and reference denosumab has no clinical impact considering the high sensitivity and specificity of the assay and further evaluation of immunogenicity impact. "We are excited to announce the additional evidence from the RCT that further supports the biosimilarity between CT-P41 and reference denosumab in treating PMO," said Hetal Patel, PharmD, MBA, Head of Medical Affairs at Celltrion USA. "These results further underline the capabilities of our dedicated biosimilar platform and anticipated diversification of our portfolio." Results of the single transition from the reference tocilizumab to CT-P47 from a Phase III RCT were also presented at the ACR. The 1-year results showed that CT-P47 had comparable and sustained efficacy, safety and immunogenicity profiles in patients with active moderate-to-severe rheumatoid arthritis (RA) compared to the reference tocilizumab even after switching. These data further support biosimilarity of CT-P47.[2] "Biosimilars offer cost savings and health gains for our patients and play an important role in treating rheumatic diseases," said Prof. Gerd-Rüdiger Burmester, MD, Professor of Medicine and Rheumatology, Senior Professor in the Department of Rheumatology and Clinical Immunology at Charité - Universitätsmedizin Berlin, Germany. "The RCT data of CT-P47 presented at ACR further establish the comparable safety and efficacy of biosimilars to their reference products." About Celltrion Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion currently has five biosimilars approved by the U.S. FDA: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd) and YUFLYMA®(adalimumab-aaty) as well as a novel biologic ZYMFENTRA®. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit: www.celltrionusa.com. About CT-P41 (biosimilar candidate of denosumab) CT-P41 is a proposed biosimilar of reference denosumab, a fully human monoclonal antibody that binds the cytokine receptor activator of NF-κb ligand (RANKL). Based on data from the Phase III clinical trial designed to evaluate the efficacy, safety, and immunogenicity of CT-P41 compared to the reference denosumab, CT-P41 was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in November 2023 and March 2024, respectively. About CT-P47 (biosimilar candidate of tocilizumab) CT-P47, containing the active ingredient tocilizumab, is a recombinant humanized monoclonal antibody that acts as an interleukin 6 (IL-6) receptor antagonist. Based on data from the global Phase III clinical trial designed to evaluate the efficacy, pharmacokinetics (PK), safety, and immunogenicity of CT-P47 compared to reference tocilizumab, CT-P47 was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in January and February 2024, respectively. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Inc./Celltrion USA that may constitute forward-looking statements, under pertinent securities laws. These statements may be identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing, "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Inc./Celltrion USA's management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements. Such Risks and uncertainties may include, among other things, uncertainties regarding the launch timing and commercial success of Celltrion in the United States; the uncertainties inherent in supply chain, manufacturing, research and development, and the possibility of unfavorable new clinical data and further analyses of existing clinical data as it relates to Celltrion products; intellectual property and/or litigation/settlement implications; decisions by the FDA impacting labeling, manufacturing processes, safety, promotion, and/or other matters that could affect the availability or commercial potential of Celltrion products; and uncertainties regarding access challenges for our biosimilar products where our product may not receive appropriate formulary access or remains in a disadvantaged position relative to competitive products; and competitive developments. A further description of risks and uncertainties can be found in Celltrion's Annual Report. Although forward-looking statements are based upon what management of Celltrion Inc./Celltrion USA believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion Inc./Celltrion USA undertakes no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements. Trademarks PROLIA® and XGEVA® are registered trademarks of Amgen Inc. ACTEMRA® is a registered trademark of Chugai Seiyaku Kabushiki Kaisha Corp., a member of the Roche Group. References [1] Jean-Yves Reginster et al., Efficacy and Safety Results of CT-P41 (Proposed Denosumab Biosimilar) Compared to Reference Denosumab in Postmenopausal Women with Osteoporosis: 78-Week Results from Phase 3 Randomized Controlled Trial. Oral Presentation (abstract no. 2563). Presented at ACR 2024 [2] Gerd Burmester et al., Similar Efficacy, PK, Safety, and Immunogenicity of Tocilizumab Biosimilar (CT-P47) and Reference Tocilizumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis: Week 52 Results from the Phase III Single Transition Study. Poster Presentation (abstract no. 0502). Presented at ACR 2024. [3] Jean-Yves Reginster et al., Impact of Immunogenicity on Clinical Outcomes in Postmenopausal Women with Osteoporosis: Results from a Randomized Controlled Phase 3 Study to Compare CT-P41 (Proposed Denosumab Biosimilar) and Reference Denosumab. Poster Presentation (abstract no. 2144). Presented at ACR 2024. [4] Denosumab U.S. Prescribing Information (2024)