Docetaxel

中国上海，2025年5月23日，科济药业（股票代码：2171.HK），一家专注于开发创新CAR-T细胞疗法的生物制药公司宣布，舒瑞基奥仑赛注射液（产品编号：CT041，一款靶向Claudin18.2蛋白的自体CAR-T细胞治疗候选产品）在中国开展的针对晚期胃癌/食管胃结合部癌的确证性II期临床试验（CT041-ST-01, NCT04581473）的研究结果摘要已于ASCO网站公布。···研究名称靶向Claudin18.2 CAR-T细胞（舒瑞基奥仑赛注射液）对比研究者选择治疗用于既往治疗失败的晚期胃/食管胃结合部癌患者：随机、开放标签、II期试验（CT041-ST-01）的主要结果 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)摘要编号4003会议类型与名称口头摘要会议——胃肠癌专题：胃食管癌、胰腺癌与肝胆癌 Oral Abstract Session— Gastrointestinal Cancer— Gastroesophageal, Pancreatic, and Hepatobiliary口头报告日期及时间美国中部（夏令时）5月31日 下午3:00-6:00，即北京时间 2025年6月1日 凌晨4:00-7:00这是一项在中国开展的开放标签、多中心、随机对照临床试验，旨在对比舒瑞基奥仑赛注射液与现有标准治疗在Claudin18.2表达阳性、至少二线治疗失败晚期胃/食管胃结合部癌（G/GEJC）患者中的有效性和安全性。主要终点为独立评审委员会（IRC）评价的无进展生存期（PFS），关键次要终点为总生存期（OS）。数据截止日期为2024年10月18日。入组患者以2:1的比例随机分配至舒瑞基奥仑赛组（satri-cel/CT041组）或研究者选择治疗组（TPC组）。舒瑞基奥仑赛组受试者将接受CT041输注（250×106 /次，最多3次输注）。TPC组受试者将根据研究者评估，接受一种标准治疗（SOC）药物（包括阿帕替尼、紫杉醇、多西他赛、伊立替康或纳武利尤单抗）。TPC组受试者如出现疾病进展或药物不耐受，根据研究者判断可接受后续的CT041治疗。从2022年3月29日至2024年8月16日，共有156例受试者被随机分配至CT041组（n=104）或TPC组（n=52）。其中，TPC组中有20例受试者接受了后续的CT041治疗。所有受试者既往均接受过至少二线治疗，CT041组和TPC组分别有26.9% vs 19.2%受试者接受过至少三线治疗；Lauren弥漫型/混合型比例71.2% vs 65.4%；腹膜转移比例69.2% vs 59.6%。在ITT即所有随机人群中：基于IRC评价，CT041较标准治疗可显著延长PFS（mPFS 3.25个月 vs 1.77个月；HR 0.366，95% CI：0.241，0.557；p<0.0001），达到本试验的主要终点，患者疾病进展/死亡风险显著下降达63%。同时OS显示出明显的获益趋势（mOS 7.92个月 vs 5.49个月；HR 0.693，95%CI：0.457，1.051；单侧p=0.0416），即便在CT041组15.4%（16例）未能接受细胞输注、TPC组近40%（20例）后续接受CT041输注的情况下，CT041组患者死亡风险下降仍超过30%。更为重要的是，在mITT即实际用药人群中：两组接受试验药物的受试者共136例，其中CT041组88例和TPC组48例。CT041组和TPC组基于IRC评价的mPFS为4.37个月 vs 1.84个月，HR 0.304（95%CI：0.195，0.474），患者疾病进展/死亡风险下降70%；mOS为8.61个月 vs 5.49个月，HR 0.601（95%CI：0385，0.939），死亡风险下降40%。以上结果显示，在实际接受了细胞输注的患者中，CT041的治疗获益更加明显。值得注意的是，TPC组20例接受CT041输注受试者的mOS达到9.20个月。两组所有接受CT041输注的108例受试者（其中CT041组88例，TPC组20例）mOS达9.17个月，而TPC组28例未使用CT041治疗者mOS仅3.98个月（HR 0.288；95%CI：0169，0.492）。由此进一步提示，CT041输注可以为患者带来明显的生存获益。安全性方面，舒瑞基奥仑赛注射液治疗的整体耐受性良好，仅4例发生3级细胞因子释放综合症（CRS），无4-5级CRS，无任何免疫效应细胞相关神经毒性综合征（ICANS）发生。这是全球范围内实体瘤CAR-T领域首个开展的确证性随机对照试验。研究结果显示，在CLDN18.2表达阳性、至少二线治疗失败的G/GEJC患者中，舒瑞基奥仑赛对比标准治疗可显著改善PFS，并展现出有临床意义的OS获益，同时具有可控的安全性特征。上述结果支持舒瑞基奥仑赛成为晚期G/GEJC患者新的标准治疗方案。关于舒瑞基奥仑赛注射液舒瑞基奥仑赛注射液是一款潜在全球同类首创的、靶向Claudin18.2蛋白的自体CAR-T细胞治疗候选产品，用于治疗Claudin18.2阳性实体瘤，主要治疗胃癌/食管胃结合部腺癌及胰腺癌。已开展的试验包括在中国开展的研究者发起的临床试验（CT041-CG4006, NCT03874897），在中国开展的针对晚期胃癌/食管胃结合部腺癌的确证性II期临床试验（CT041-ST-01, NCT04581473），在中国开展的针对胰腺癌辅助治疗的I期临床试验（CT041-ST-05, NCT05911217），在中国开展的用于胃癌/食管胃结合部腺癌患者术后辅助治疗后巩固治疗的研究者发起的临床试验（CT041-CG4010，NCT06857786）以及在北美开展的针对晚期胃癌或胰腺癌的1b/2期临床试验（CT041-ST-02, NCT04404595）。2025年3月，舒瑞基奥仑赛注射液获得了中国国家药品监督管理局药品审评中心授予的突破性治疗药物品种认定，拟定适应症为既往接受过至少二线治疗失败的Claudin18.2表达阳性的晚期胃癌/食管胃结合部腺癌。2022年1月，舒瑞基奥仑赛注射液被美国FDA授予“再生医学先进疗法”（RMAT）认定用于治疗Claudin18.2阳性的晚期胃癌/食管胃结合部腺癌。2020年9月，舒瑞基奥仑赛注射液被美国FDA授予“孤儿药”认定用于治疗胃癌/食管胃结合部腺癌。（模块内滑动，了解更多）关于科济药业科济药业（股票代码：2171.HK）是一家生物制药公司，专注于开发创新CAR-T细胞疗法，以满足未满足的临床需求，包括但不限于血液恶性肿瘤、实体瘤及自身免疫性疾病。公司形成了从靶点发现、临床前研究、产品临床开发到商业规模生产的CAR-T细胞研究与开发的端到端能力。公司通过自主研发新技术以及拥有全球权益的产品管线，以解决现有CAR-T细胞疗法的挑战，比如提高安全性，提高实体瘤治疗的疗效和降低治疗成本等。科济药业的使命是成为全球生物制药领域的领导者，为全球癌症及其他疾病的患者提供创新和差异化的细胞疗法，使癌症及其他疾病可治愈。（模块内滑动，了解更多）前瞻性声明本新闻稿中所有不属于历史事实或与当前事实或当前条件无关的陈述都是前瞻性陈述。此类前瞻性声明表达了本集团截至本新闻稿发布之日对未来事件的当前观点、预测、信念和预期。此类前瞻性声明是基于本集团无法控制的一些假设和因素。因此，它们受到重大风险和不确定性的影响，实际事件或结果可能与这些前瞻性声明有重大差异，本新闻稿中讨论的前瞻性事件可能不会发生。这些风险和不确定性包括但不限于我们最近的年度报告和中期报告以及在我们公司网站https://www.carsgen.com 上发布的其他公告和报告中「主要风险和不确定性」标题下的详细内容。对于本新闻稿中的任何预测、目标、估计或预测的实现或合理性，我们不作任何陈述或保证，也不应依赖这些预测。（模块内滑动，了解更多）联系科济药业更多信息，请访问公司网站：https://www.carsgen.com/公共关系：PR@carsgen.com投资者关系：IR@carsgen.com往期推荐科济药业CT071的摘要已公布于EHA网站科济药业通用型BCMA CAR-T产品CT0596初步临床数据公布，显示安全性和有效性“创·在上海 创TALK”丨对话科济药业控股有限公司创始人、董事长、CEO李宗海博士CAR-T助力22岁骨髓瘤患者生命再起航光明启，“泽”未来 | 钱文斌教授谈CAR-T细胞治疗：从临床实践到血液肿瘤治疗未来展望

SHANGHAI, May 22, 2025 /PRNewswire/ -- CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on developing innovative CAR T-cell therapies, announces that an abstract of the research results of the confirmatory Phase II clinical trial of satricabtagene autoleucel ("satri-cel", CT041) (an autologous CAR T-cell product candidate against protein Claudin18.2) for advanced gastric/gastroesophageal junction cancer (G/GEJC) in China (CT041-ST-01, NCT04581473) is available on the American Society of Clinical Oncology ("ASCO") website. Title 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) Abstract Number 4003 Session Type and Title Oral Abstract Session – Gastrointestinal Cancer— Gastroesophageal, Pancreatic, and Hepatobiliary Session Date and Time May 31, 2025, 3:00–6:00 PM CDT This open-label, multicenter, randomized controlled trial (RCT) was conducted in China to compare the efficacy and safety of satri-cel versus standard of care (SOC) in CLDN18.2 positive, advanced G/GEJC patients with failure to at least 2 prior lines of treatment. The primary endpoint was PFS assessed by the Independent Review Committee (IRC). Key secondary endpoint was OS. Data cutoff date was Oct 18, 2024. Patients were randomized (2:1) to satri-cel arm or TPC arm. For satri-cel arm, satri-cel dose of 250×106 cells were infused up to 3 times. For TPC arm, one of the standard of care (SOC) drugs (apatinib, paclitaxel, docetaxel, irinotecan or nivolumab) was given per physician's decision. Those who experienced disease progression or drug intolerance in TPC arm could receive subsequent satri-cel, if eligible. From Mar 29, 2022 to Aug 16, 2024, a total of 156 patients were randomized to satri-cel arm (n = 104) or TPC arm (n = 52). Twenty patients in TPC arm received subsequent satri-cel. Median number of prior systemic therapies was 2 in both arms, and 26.9% vs 19.2% had received ≥3 lines. 71.2% vs 65.4% were Lauren diffuse/mixed type. 69.2% vs 59.6% had peritoneal metastasis. In ITT population (i.e., all randomized patients), satri-cel arm showed significant improvement in mPFS by IRC (3.25m vs 1.77m; HR 0.366, 95% CI:0.241, 0.557; p < 0.0001) meeting the primary endpoint with a 63% reduction in risk of disease progression or death. Even with 15.4% (n=16) patients in satri-cel arm failing to receive infusion and nearly 40% (n=20) patients in TPC arm receiving subsequent satri-cel, satri-cel arm still demonstrated a clear trend toward OS benefit (mOS 7.92m vs 5.49m; HR 0.693, 95% CI: 0.457, 1.051; one-sided p = 0.0416) , showing over 30% reduction in mortality risk. More importantly, in mITT population (i.e. patients who were actually treated), 136 patients received study drug (satri-cel 88 patients vs TPC 48 patients), mPFS by IRC was 4.37m vs 1.84m, HR 0.304 (95% CI: 0.195, 0.474), representing a 70% reduction in risk of disease progression or death. The mOS was 8.61m vs 5.49m, HR 0.601 (95%CI: 0.385, 0.939), corresponding to 40% reduction in mortality risk. These results demonstrate that satri-cel treatment benefits were pronounced in patients who actually received CAR-T infusion. Of particular note, 20 TPC patients with subsequent satri-cel infusion achieved an mOS of 9.20 months. When analyzing all 108 patients who received satri-cel infusion (88 patients in satri-cel arm and 20 patients in TPC arm), the mOS reached 9.17 months, while the mOS of 28 patients in TPC arm who did not receive satri-cel treatment was only 3.98 months (HR 0.288; 95% CI: 0.169-0.492). These findings provide further evidence that satri-cel infusion can deliver substantial survival benefits for patients. Furthermore, satri-cel demonstrated a favorable overall safety profile. Only 4 cases of Grade 3 cytokine release syndrome (CRS) were reported, and no Grade 4-5 CRS events were observed. No immune effector cell-associated neurotoxicity syndrome (ICANS) was reported. This is the first confirmatory RCT of CAR-T therapy in solid tumors. Satri-cel demonstrated significant PFS improvement and a clinically meaningful OS benefit with a manageable safety profile in CLDN18.2 positive G/GEJC patients with failure to at least 2 prior lines of treatment, compared to standard therapy. These results support satri-cel as a potential new SOC for advanced G/GEJC. 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 I 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 Breakthrough Therapy Designation by the Center for Drug Evaluation of China's National Medical Products Administration 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. 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