Leiomyosarcoma

招募受试者 正大天晴药业集团股份有限公司正在全国开展一项“评价盐酸安罗替尼胶囊联合TQB2450注射液对比化疗治疗非微卫星高度不稳定（非MSI-H）或非DNA错配修复缺陷（非dMMR）的复发性或转移性子宫内膜癌的随机、对照、开放、多中心III期临床试验”。这项研究已得到国家药品监督管理总局的批准（批件号：2021LP02007、2021LP02013、2021LP02014、2021LP02015）并通过中心伦理，现在全国招募受试者。 试验药物简介 TQB2450注射液（通用名：贝莫苏拜单抗注射液）是正大天晴自主研发的一款全新序列的创新人源化PD-L1单克隆抗体，于2024年5月获国家药品监督管理局（NMPA）批准上市，首个适应症是联合盐酸安罗替尼胶囊、卡铂和依托泊甘用于广泛期小细胞肺癌（ES-SCLC）患者的一线治疗。 2024年2月，贝莫苏拜单抗联合盐酸安罗替尼胶囊治疗复发性或转移性子宫内膜癌的上市申请获CDE受理，并被纳入优先审评审批程序。 主要入选标准 （1）经组织病理学证实的复发性或转移性晚期子宫内膜癌； （2）既往接受1线含铂为基础的双药治疗失败。允许前期进行新辅助和/或辅助化疗（单用化疗、同步放化疗或者作为序贯疗法），如新辅助/辅助治疗期间或充分治疗结束后6个月以内出现疾病进展/复发，则可视为一线化疗治疗失败； （3）提供生物样本进行MMR/MSI状态检测，且检测结果为非微卫星高度不稳定（非MSI-H）或非DNA错配修复缺陷（非dMMR）； （4）无法进行手术/放疗根治的患者； （5）年龄：≥18周岁（签署知情同意书时）；ECOG PS评分：0-1分；预计生存期超过3个月； （6）至少具有一个可测量病灶（RECIST 1.1）； （7）主要器官功能良好。 主要排除标准 （1）既往使用过贝伐珠单抗、恩度、安罗替尼、阿帕替尼、仑伐替尼、索拉非尼、舒尼替尼、瑞戈非尼、呋喹替尼等抗血管生成药物或针对PD-1、PD-L1等相关细胞和免疫治疗药物； （2）研究治疗开始前2周内接受过NMPA批准药物说明书中明确具有抗肿瘤适应症的中成药（包括复方斑蝥胶囊、康艾注射液、康莱特胶囊/注射剂、艾迪注射液、鸦胆子油注射剂/胶囊、消癌平片/注射剂、华蟾素胶囊等）治疗； （3）病理提示有癌肉瘤（恶性mullerian混合肿瘤）、子宫内膜平滑肌肉瘤或其它高等级肉瘤，或子宫内膜间质肉瘤； （4）首剂试验药物治疗前1周内曾接受过针对子宫内膜癌的激素治疗； （5）研究治疗开始前4周内曾接受过手术、化疗、放疗或其它抗癌疗法（从末次治疗结束时间开始计算洗脱期）。口服靶向药不足 5 个药物半衰期； （6）有已知中枢神经系统转移和/或癌性脑膜炎的受试者；除非无症状，或接受过治疗且稳定，在脑转移治疗后至少2周未发现新发脑转移或脑转移扩大的影像学证据，并在研究治疗开始之前停止了类固醇或抗惊厥药物治疗至少14天； （7）3年内出现过或当前同时患有其它恶性肿瘤； （8）不能控制的需要反复引流的胸腔积液、心包积液或腹水（研究者判断）。 研究中心信息 如果您符合以上条件或有意向参加该项研究，请扫描下方二维码报名。 正大天晴药业集团是集药品的科研、生产和销售为一体的创新型医药集团企业，员工14000多人，是国内抗肿瘤、肝病、呼吸领域的知名企业，位列中国医药工业百强榜第12位，为中国医药研发产品线最佳工业企业。 正大天晴始终将科技创新作为企业可持续发展的重要战略，为积极研制创新和高品质药品不懈努力，重点打造肿瘤、肝病、呼吸等产品集群。公司年研发投入占销售收入的17%，在研项目148个，其中创新药80个，先后承担国家重大专项课题33项，累计有效申请及专利3080项，拥有有效授权专利1137项，形成了“上市一代、储备一代、研发一代”的良性格局。 健康科技，温暖更多生命。为社会提供优质产品是我们不变的初心，正大天晴希望为患者提供更佳的健康解决方案，为提高公众健康水平与药品可及性不懈努力。 注：以上数据来自正大天晴内部报表，统计时间截至2023年底

LEXINGTON, Mass.--( BUSINESS WIRE )--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, presented data today at the European Society for Medical Oncology (ESMO) Congress held in Barcelona, Spain. The data from a Phase 1 study of botensilimab (BOT), an investigational Fc-enhanced CTLA-4 inhibitor, in combination with balstilimab (BAL), an investigational PD-1 antibody, showed clinical activity in patients with refractory sarcomas, a population with limited treatment options. "The continued activity with additional patients and longer follow-up of BOT/BAL in this study reinforces it's potential as an important treatment option for patients with sarcomas," said Dr. Breelyn A Wilky, University of Colorado Cancer Center. "The deep and durable responses we are observing, particularly in late line patients with poorly immunogenic or ‘cold’ sarcomas like visceral angiosarcoma, leiomyosarcoma, and dedifferentiated liposarcoma, are significant. These findings highlight the potential of BOT/BAL to deliver extended survival and a meaningful clinical benefit for patients who previously had very limited options." Study Highlights 64 patients with relapsed/refractory sarcomas (median of 3 prior lines of therapy) were treated with 1 or 2 mg/kg BOT + 3 mg/kg BAL. 52 patients were efficacy evaluable with at least one post-baseline 6-week imaging scan. ORR and DOR reporting will be based on the unconfirmed response in this cohort. Majority of sarcoma subtypes included angiosarcoma (39%) and leiomyosarcoma (34%). Clinical Findings 23% overall response rate (ORR) was observed in the full sarcoma cohort, with a median duration of response (DOR) of 21.7 months. 12-month overall survival (OS) was 69% and the median OS was not reached. 39% ORR achieved in the angiosarcoma subtype (33% in cutaneous and 44% in visceral), with a median DOR of 21.7 months. 12-month OS was 64% and the median OS was not reached. A representative patient with visceral angiosarcoma achieved a durable response, ongoing beyond 3 years, that has been maintained off-therapy. The adverse event profile of BOT+ BAL was manageable and reversible with no new safety signals identified. "The updated sarcoma data presented at ESMO underscore the transformative potential of botensilimab and balstilimab for patients with refractory sarcomas who have exhausted other treatment options," said Dr. Steven O’Day, Chief Medical Officer at Agenus. "Seeing these metastatic sarcoma patients experience tumor reduction, with significant and durable responses is incredibly encouraging. BOT/BAL not only offers hope to patients with sarcoma but also holds promise for redefining the standard of care across other historically IO-resistant cancers." The presentation is available on the Agenus website at https://agenusbio.com/publications . About Botensilimab Botensilimab is an investigational human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2023, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.

LEXINGTON, Mass.--( BUSINESS WIRE )--Agenus Inc. (“Agenus”) (Nasdaq: AGEN), a leader in developing novel immunological agents to treat various cancers, today announced that updated data from the clinical trial of botensilimab and balstilimab in refractory sarcomas will be featured in a mini oral presentation at the European Society for Medical Oncology (ESMO) Congress, taking place September 13-17, 2024, in Barcelona, Spain. The presentation will feature updated efficacy and safety data from the large, ongoing Phase 1 trial, highlighting the potential of this combination therapy in treating patients with refractory sarcomas, including visceral angiosarcoma and leiomyosarcoma, populations with limited therapeutic options. Botensilimab, a novel investigational Fc-enhanced CTLA-4 inhibitor, and balstilimab, an investigational PD-1 antibody, have shown promising clinical responses in multiple tumor types, including "cold" tumors that are typically unresponsive to standard therapies. Presentation Details: Abstract Title: Updated efficacy and safety of botensilimab plus balstilimab in patients with refractory metastatic sarcoma from an expanded phase 1 study Abstract Number: 1726MO Presenting Author: Breelyn A. Wilky, MD, University of Colorado Cancer Center Session : Mini Oral Session, Sarcoma Session Date and Time: Friday, September 13 th , 2024, at 4:00 p.m. – 5:30 p.m. CEST (10:00 a.m. – 11:30 a.m. ET) Complete abstracts are available through the ESMO Congress program . The presentation will also be available in the publications section of the Agenus website following the ESMO Congress on Friday, September 13th. About Botensilimab Botensilimab is an investigational human Fc enhanced CTLA-4 blocking antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,100 patients have been treated with botensilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov with the identifiers NCT03860272, NCT05608044, NCT05630183, and NCT05529316. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission is to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2023, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement.