Aldesleukin

48 岁的毛先生享受着重生后的幸福生活—— 谁能想到，两年前的此刻，他正蜷缩在病床上用手机给自己拍 "遗照"。幸运的是，在接受国研新型免疫疗法后，他的肿瘤病灶不断缩小，直至丧失代谢活性，他兴奋地说： 我这是细胞治疗治好了，什么药都不用吃了 。 胰腺癌，素有 “癌中之王” 的恶名，其恶性程度极高，病情进展迅猛，现有的治疗手段往往难以取得理想疗效，患者的预后极差，总体 5 年生存率不足 10%。 值得振奋的是，全新免疫疗法--TIL的问世，为这类患者点亮了新的希望之光，目前世界各地已有成功治疗的患者肿瘤得到有效控制。近期，中国也报道了一位接受国研TIL 疗法后肿瘤靶病灶迅速消退的案例，引起巨大轰动！ 国研创新TIL 疗法改写晚期胰腺癌生命剧本，重回正常生活 2021年，毛先生不幸被这头 “病魔巨兽” 盯上，确诊为胰腺癌。尽管他果断接受了手术治疗，可命运似乎并未就此放过他，癌症很快复发，化疗、免疫治疗、中药…… 能尝试的方法都尝试了，病情却依旧每况愈下，毛先生的生活陷入了无边的黑暗，绝望如影随形。 “胰头部位复发病灶已接近 10 厘米 ，有橙子那么大了，还发生了肝转移。那一刻，我觉得自己的时间可能真的不多了。我当时躲在病房厕所，用手机给自己拍了张照片 —— 想着万一没机会了，也算给家人留个念想。” 回忆起 2022 年那段至暗时刻，毛先生的声音仍带着一丝颤抖，眼中满是劫后余生的感慨。当时的他，饭吃不下，路走不动，身体极度虚弱，生活自理都成了奢望，每一次呼吸都伴随着病痛的折磨，生命之火如风中残烛，摇摇欲熄。 幸运的是，在他几乎要放弃希望之时，国内一家知名的肿瘤中心正在开展一项 新型细胞免疫疗法-- TIL 的临床试验，像一道希望之光，穿透阴霾照进了他的世界。2022 年 8 月，毛先生怀着忐忑的心情接受了TIL 疗法，这是他最后的希望，也是他与命运的一场豪赌。 奇迹，在悄然间降临。2022 年 10 月，TIL 回输后 仅仅 6 周 ，复查影像显示，他胰头部位的复发病灶竟快速 缩小至 3 厘米 ，残余的肝转移病灶更是消失得无影无踪。不仅如此，多个原本居高不下的肿瘤标记物也奇迹般地恢复至正常水平。此后的每一次复查，他的肿瘤病灶都在不断缩小，直至丧失代谢活性。 专家介绍到：传统治疗手段对他而言几乎失效。但 TIL 疗法就像从肿瘤 “内部” 招募了一支 “特种部队” —— 我们从他的肿瘤组织中提取淋巴细胞，在体外扩增到百亿级，这些细胞带着对癌细胞的 “记忆”，回输后精准清除病灶。如果把免疫系统比作军队，TIL 就是从战场（肿瘤组织）里挑出的老兵，它们熟悉癌细胞的 “ 长相 ”（抗原），归巢能力强，杀伤精准。而且源自患者自身，几乎没有排异反应，还能形成长期免疫记忆 —— 毛先生回输两年后，病灶仍无代谢活性，这就是 “ 记忆士兵 ” 在持续巡逻。 如今的毛先生，早已摆脱了病魔的纠缠，重新回归了正常生活。他的脸上洋溢着健康的笑容，身形矫健，很难想象他曾在死亡边缘徘徊。“现在生活挺正常的，饭量比以前还多一点，每天就骑着三轮车装货、卸货、拉石材，日子过得踏实又自在。” 毛先生笑着说道，眼中满是对生活的热爱和对未来的憧憬。他的康复，不仅仅是一个人的重生，更是 TIL 疗法神奇疗效的有力见证，为无数在黑暗中挣扎的癌症患者点燃了希望之火。 喜讯！中国成功研发全球首款无需清淋TIL疗法，国内多家中心启动招募！ 相信看完上面振奋人心的案例，病友们都想了解张先生接受的这款疗法究竟是何方神圣。 GC101是 上海君赛生物已成功研发 全球首款无需清淋，无需IL-2注射的天然TIL细胞疗法 ，并于2022年4月经国家药监局批准进入临床I期。目前，它已进入关键 II 期临床（MIZAR - 003），正在全国 20 个省（直辖市、自治区）的 24 个中心进行患者招募。 临床数据显示： 针对肺癌、黑色素瘤、宫颈癌等多种晚期恶性实体肿瘤，GC101的客观缓解率（ORR）超38%，并且已有4例患者肿瘤完全清除，达到完全缓解（CR），其中无瘤生存最久时间已超2年，另有6例患者获得PR疗效（肿瘤缩小＞30%）。 这种国研创新型TIL疗法与美国上市的AMTAGVI™（Lifileucel）不同，所有患者仅需入住普通病房即可接受治疗，TIL细胞回输前 无需接受高强度非清髓性清淋预处理，TIL细胞回输后无需输注任何剂量的IL-2。 简化后的临床方案仍可保证TIL细胞在患者体内有效增殖， 极大避免AMTAGVI™黑框警告相关不良反应 （如：治疗相关死亡事件、持续性严重细胞减少症、严重感染、心肺功能和肾功能损伤等）发生风险， 大幅提高TIL疗法安全性、便捷性及可及性。 2025年 ASGCT 上公布的研究成果显示，国研自主创新的DeepTIL®细胞富集扩增平台(Dual-frEE Platform (feeder cell free and IL-2 free))，无需滋养细胞和高浓度IL-2即可成功从多种实体瘤组织(包括 脑胶质瘤、肉瘤、卵巢癌、结直肠癌、胃癌、胰腺癌等 免疫细胞浸润少的“冷肿瘤”)中扩增出足量高活性的非IL-2依赖型TIL细胞，并且在无需联用任何剂量IL-2的情况下，体内和体外均展现出良好的肿瘤杀伤能力。 患者回输前无需清淋级化疗预处理，治疗后无需联用任何剂量IL-2，治疗期间无需入住无菌病房并施行重症护理等临床方案上的创新得到受试者和研究者的双重认可，亲身实证这项创新研究成果的科学性和实用性。 申请国研TIL疗法 好消息是，目前GC101针对晚期黑色素瘤及实体瘤的临床试验仍在进行中，很多患者已通过全球肿瘤医生网成功入组。 主要入组条件 18-75岁，男女不限，无严重基础疾病； 仅患一种恶性实体肿瘤，恶性黑色素瘤、肺癌、头颈部鳞癌、食管鳞癌、宫颈癌、子宫内膜癌等优先； 经标准治疗失败或缺乏有效治疗方法； 至少有2个病灶，身体情况可支持手术取材，取材病灶未接受过局部治疗（如放疗、射频治疗、溶瘤病毒、溶瘤细菌等）。 想寻求TILs及其他国内外新抗癌治疗帮助，且经济条件允许的情况下，可以先将病历提交至全球肿瘤医生网医学部进行初步评估，一旦审核通过，有机会获得”天价“疗法免费治疗的机会。 专家提醒！手术后保存组织是一场“生命接力” 99%的肿瘤患者都不知道，自己手术切除的肿瘤组织中深藏着杀癌能力最强的一群免疫细胞，肿瘤浸润淋巴细胞（TIL）。 而几乎所有患者的肿瘤组织在手术后仅取一小部分做成病理蜡块，其余部分就直接作为医疗垃圾处理掉，浪费了我们自身宝贵的抗癌资源！ 建议大家在手术前争得手术医生的同意，将新鲜手术组织保存，交由专业机构将TIL细胞提取，可以在术后回输预防复发，或者是先冻存起来，以备未来不时之需。因为手术后未经其他治疗时新鲜组织中的TIL细胞对肿瘤的杀伤能力才是最强的，一旦接受化疗和放疗，免疫细胞的杀伤能力会被削弱。具体的方法和冻存流程大家可以提交病历至全球肿瘤医生网医学部。 复旦大学附属肿瘤医院妇瘤科主任吴小华教授接受采访时说到：肿瘤患者初次手术时，肿瘤组织中的 TIL 细胞如同 “年轻士兵”，数量充足、活性最强。但晚期复发时，肿瘤微环境恶化，TIL 细胞可能 “疲惫不堪”。我们曾对比过早期与复发期的 TIL 细胞 —— 早期样本的杀伤活性是复发期的 3 倍以上。 每位癌症患者术后，如果保存 5-10 克肿瘤组织，在 - 196℃液氮罐中可保存 20 年以上。就像给未来的自己存下 “免疫保险”，一旦复发，这份 “生命种子” 能快速唤醒免疫系统，重续生命契约！ 专家强调，这不是 “锦上添花”，而是 “雪中送炭”。当 TIL 疗法成为晚期癌症的 “标配武器”，手术时保存的组织就是启动武器的 “钥匙”。我们希望用 5 年时间，让 90% 的癌症患者知道这份 “生命备份” 的重要性。这将是复发后战胜癌症最宝贵的机会之一。这是现代医学最温暖的 “未雨绸缪”，也是科技对生命最庄重的承诺。 毛先生并非个例，随着医学研究的不断深入，TIL 疗法正逐渐成为癌症治疗领域的新兴力量，为越来越多的晚期癌症患者改写命运。2024 年 2 月，美国 IOVANCE 公司全球首个 TIL 疗法 Lifileucel 经 FDA（美国食品药品监督管理局）批准上市，用于治疗 PD - 1 抗体治疗失败的晚期黑色素瘤。这一里程碑事件，标志着 TIL 疗法正式迈入商业化阶段，为全球癌症治疗格局带来了新的变革，为那些对传统治疗手段耐药的患者打开了一扇新的生命之门。 案例来源：君赛生物 本文为全球肿瘤医生网原创，未经授权严禁转载

June 02, 2025 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today announced that the Journal of Clinical Oncology has published the final analysis from the Phase 2 C-144-01 clinical trial evaluating the individualized T cell therapy Amtagvi® (lifileucel) in patients with advanced melanoma. These five-year follow-up results are being simultaneously presented during an oral session today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. This five-year analysis of the C-144-01 trial represents unprecedented durability and duration of follow-up in advanced melanoma patients previously treated with anti-PD-1 and targeted therapy, where applicable. The analysis includes 153 patients from cohorts 2 and 4 of the C-144-01 trial. One-time Amtagvi treatment demonstrated long-term benefit in heavily pretreated patients, including deep and durable responses, meaningful overall survival without further treatment, and no new or late-onset adverse events at a median follow-up of 57.8 months. The objective response rate was 31.4% with a median time to response of 1.4 months and a median duration of response of 36.5 months. Nearly one third of responders (31.3%) completed the five-year assessment with ongoing responses. The median overall survival (mOS) was 13.9 months with a five-year survival rate of 19.7%. Survival outcomes were consistent among responders, regardless of time of onset of response to Amtagvi therapy. The observed safety profile was consistent with that of nonmyeloablative lymphodepletion and interleukin-2 administration. The incidence of AEs decreased rapidly within the first two weeks after Amtagvi infusion, and there were no new or late-onset treatment-related AEs. Theresa Medina, M.D., medical oncologist at the University of Colorado Cancer Center on the Anschutz Medical Campus, stated, “Amtagvi has demonstrated long-term benefit and meaningful overall survival in a difficult-to-treat melanoma patient population resistant to immune checkpoint inhibitor therapy. Five years following one-time Amtagvi treatment, responses persisted or deepened during an extended treatment-free interval for some patients. Amtagvi offers a new standard of care for the advanced melanoma community and sets a new bar for one-time cell therapies with curative intent in solid tumors.” In February 2024, the U.S. Food and Drug Administration granted accelerated approval to Amtagvi for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The approval was based on overall response rate and duration of response from the C-144-01 clinical trial. With this approval, Amtagvi became the first one-time T cell therapy for a solid tumor cancer as well as the first approved treatment option for patients with advanced melanoma after anti-PD-1 and targeted therapy. Iovance is also conducting TILVANCE-301, a Phase 3 trial in frontline advanced melanoma to confirm clinical benefit. C-144-01 is a global, multicenter Phase 2 study in which patients received treatment with lifileucel. The study enrolled patients with metastatic melanoma who were previously treated with at least one systemic therapy, including a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor. Efficacy was established on the basis of objective response rate (ORR) and duration of response (DOR) by Independent Review Committee (IRC) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. The pivotal Cohort 4 and supportive Cohort 2 of Study C-144-01 enrolled patients that met the same primary eligibility criteria, had the same assessments, and had received the same regimen and AMTAGVI that was produced using the same manufacturing process, and product formulation. The final five-year analysis of C-144-01 was published in the Journal of Clinical Oncology in 2025. AMTAGVI is a prescription medicine used to treat adults with a type of skin cancer that cannot be removed surgically or has spread to other parts of the body called unresectable or metastatic melanoma. AMTAGVI is used when your melanoma has not responded or stopped responding to a PD-1 blocking drug either by itself or in a combination, and if your cancer is BRAF mutation positive, a BRAF inhibitor drug with or without a MEK inhibitor drug that has also stopped working. The approval of AMTAGVI is based on a study that measured response rate. Continued approval for this use may depend on the results of an ongoing study to confirm benefit. Iovance Biotherapeutics, Inc. aims to be the global leader in innovating, developing, and delivering tumor infiltrating lymphocyte (TIL) therapies for patients with cancer. We are pioneering a transformational approach to cure cancer by harnessing the human immune system’s ability to recognize and destroy diverse cancer cells in each patient. The Iovance TIL platform has demonstrated promising clinical data across multiple solid tumors. Iovance’s Amtagvi® is the first FDA-approved T cell therapy for a solid tumor indication. We are committed to continuous innovation in cell therapy, including gene-edited cell therapy, that may extend and improve life for patients with cancer. Amtagvi® and its accompanying design marks, Proleukin®, Iovance®, and IovanceCares™ are trademarks and registered trademarks of Iovance Biotherapeutics, Inc. or its subsidiaries. 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