Anzutresgene Autoleucel

建有CGT产业交流群，请加：emworld7788，暗号：CGT 建有肿瘤战友公益互助群，请加：emworld7788，暗号：CA 2025年10月20日，Immatics N.V（纳斯达克股票代码：IMTX），一家临床阶段生物制药公司，也是PRAME精准靶向治疗领域的全球领导者，今日宣布公布16例接受anzu-cel PRAME细胞疗法治疗的转移性葡萄膜黑色素瘤患者的最新数据。 这项正在进行的1b期临床试验的葡萄膜黑色素瘤数据将于今日在2025年欧洲肿瘤内科学会（ESMO）年会第三届主席研讨会上由科罗拉多大学癌症中心医学教授Sapna Patel医学博士公布。 “转移性葡萄膜黑色素瘤患者的预后不佳，鉴于目前可用的治疗选择有限，他们代表着一个亟需更好治疗结果的群体，”医学博士Sapna Patel表示。“我相信今天公布的anzu-cel研究结果标志着转移性葡萄膜黑色素瘤患者急需的突破。这些发现凸显了anzu-cel重新定义葡萄膜黑色素瘤治疗模式的潜力，并为迫切需要更有效治疗方案的患者带来新的希望。” “我们的目标是抓住一切机会，为治疗选择有限的患者提供创新的PRAME疗法，”Immatics首席医疗官医学博士Cedrik Britten表示。“今天公布的持续强劲临床数据坚定了我们最大限度地发挥PRAME细胞疗法anzu-cel潜力的信念，并将其拓展至转移性葡萄膜黑色素瘤——一种罕见的、医疗需求极高的癌症。我们很高兴能够进一步推进我们的PRAME专营权，并为有需要的患者带来有意义的进展。” Anzu-cel 1b期试验患者入选群体：难治性转移性葡萄膜黑色素瘤患者群体 截至2025年9月24日，作为anzu-cel 1b期剂量扩展试验的一部分，16例转移性葡萄膜黑色素瘤患者接受了一次性输注anzu-cel，剂量为推荐的2期剂量（RP2D，总TCR T细胞10亿至100亿）。患者输注的TCR T细胞中位剂量约为40亿，且既往接受过2线全身治疗。患者靶病灶总直径中位值为103毫米，81%的患者出现肝脏和肝外转移。 抗肿瘤活性及持久性：anzu-cel PRAME 细胞疗法持续保持强劲的抗肿瘤活性及持久性 anzu-cel PRAME细胞疗法一次性输注的最新数据显示，其在难治性且有效治疗方案有限的患者群体中具有显著疗效： 确认客观缓解率(cORR)为67%； 疾病控制率(DCR)为88%； 中位缓解持续时间(mDOR) 为11个月（最短4.4个月，最长31.6个月） 中位无进展生存期(mPFS)为8.5个月（最短1.4个月，最长32.9个月），mFU 为10.4个月。6个月无进展生存率为69%，12个月无进展生存率为39%。 中位总生存期（mOS）未达到（最低4.3个月，最高34.2个月），mFU为14.3个月。12个月总生存率为71%。 在肝脏和肝外转移灶（包括肺、淋巴结、腹部/腹膜等）中均观察到抗肿瘤活性。16例患者中有14例存在肝脏靶病灶，接受anzu-cel治疗后，肝脏靶病灶大小中位数缩小了49.6%。 值得注意的是，16例患者中有11例接受了TCR双特异性抗体（10例靶向gp-100，1例靶向PRAME）作为既往全身治疗方案，其中6例获得确认的部分缓解，1例获得部分缓解，3例病情稳定。这些结果证明了anzu-cel在既往接受过基于TCR疗法的患者中具有抗肿瘤活性。 安全性：葡萄膜黑色素瘤患者耐受性良好，与anzu-cel的耐受性基本一致。 最常见的治疗中出现的不良事件(TEA)是预期的与淋巴细胞清除相关的血细胞减少症。预期且可控的细胞因子释放综合征 (CRS)大多为1级或2级，与作用机制一致（1级：37.5%，2级：43.8%，3级：18.8%，4级：0%）。无患者出现长期CRS，大多数CRS在第14天前消退。未观察到与anzu-cel相关的5级事件。 Anzu-cel在转移性葡萄膜黑色素瘤中的研发路径 基于转移性葡萄膜黑色素瘤患者中取得的良好临床数据，Immatics已启动一项II期临床试验，计划招募约30名葡萄膜黑色素瘤患者。该临床试验由美国和德国在葡萄膜黑色素瘤领域拥有深厚专业知识的指定研究中心开展。鉴于PRAME在葡萄膜黑色素瘤中的高表达率，临床试验纳入不再需要进行前瞻性PRAME检测。 anzu-cel在葡萄膜黑色素瘤和皮肤黑色素瘤中均表现出一致的耐受性、抗肿瘤活性和药代动力学特征，这为开展并行的后期研发策略以服务于这两类患者群体提供了强有力的依据。 关于PRAME靶点 PRAME是50多种癌症中均有表达的靶点。Immatics是PRAME精准靶向领域的全球领导者，拥有最广泛的 PRAME 特许经营权，涵盖最多的PRAME适应症和治疗模式。 Immatics PRAME特许经营权目前包括三种靶向PRAME的候选产品、两种治疗模式和一种联合疗法：anzu-cel (IMA203)PRAME细胞疗法、IMA203CD8 PRAME细胞疗法(GEN2)、IMA402 PRAME双特异性疗法以及anzu-cel与Moderna的PRAME细胞疗法增强剂的联合疗法。 关于Anzu-cel (IMA203) PRAME 细胞疗法 Anzu-cel(anzutresgene autoleucel;IMA203)是一种靶向PRAME的TCR T细胞疗法，旨在识别细胞表面HLA-A*02:01呈递的细胞内PRAME衍生肽，并启动强效且特异性的抗肿瘤反应。Anzu-cel PRAME细胞疗法目前正在一项名为“SUPRAME”的注册性随机对照3期临床试验中进行评估，该试验针对的是无法切除或转移性皮肤黑色素瘤患者，这些患者在接受至少一种检查点抑制剂治疗期间或之后病情进展。与此同时，针对PRAME阳性癌症患者的1b期临床试验也在进行中，重点关注葡萄膜黑色素瘤。 -END- ◆ 版权声明：本文由「CGT前哨」原创出品，未经授权谢绝任何形式的截取或商业转载。原创不易，感谢尊重知识与创作！加CGT产业群和肿瘤战友互助群emworld7788。 ⚠️注：本平台部分内容（包括但不限于数据、图片等）来自互联网，仅供学习参考之用，数据如有需要纠正之处请后台联系。另外如无意中侵犯版权，烦请联系，我们将第一时间作出处理。 ◆ 以上声明内容的最终解释权归本公众号所有，本声明将适用本公众号所有文章，感谢合作！

One-time infusion of anzu-cel (anzutresgene autoleucel, IMA203) PRAME cell therapy in 16 patients with metastatic uveal melanoma in the ongoing Phase 1b trial continues to show strong clinical benefit with more mature data: cORR of 67%, mDOR of 11.0 months, mPFS of 8.5 months and mOS not reached at 14.3 months mFUAnzu-cel maintains a favorable tolerability profile in metastatic uveal melanomaAnti-tumor activity observed across metastases throughout the body, including liver lesions, and in patients who received prior treatment with TCR-based therapiesGiven the promising clinical activity of anzu-cel and high PRAME prevalence in uveal melanoma, a Phase 2 cohort has been initiated in patients with metastatic uveal melanoma Houston, Texas and Tuebingen, Germany, October 20, 2025 – Immatics N.V. (NASDAQ: IMTX, “Immatics” or the “Company”), a clinical-stage biopharmaceutical company and the global leader in precision targeting of PRAME, today announced the presentation of updated data from 16 patients with metastatic uveal melanoma treated with anzu-cel PRAME cell therapy. The uveal melanoma data from the ongoing Phase 1b trial will be presented today at the European Society for Medical Oncology (ESMO) Congress 2025 during the Presidential Symposium III by Sapna Patel, M.D., Professor of Medicine, University of Colorado Cancer Center. The slides are accessible in the ‘Events & Presentations’ section of the Investors & Media section of the Company’s website. “Patients with metastatic uveal melanoma face a poor prognosis and represent a population in need of better outcomes, given the limited options currently available,” said Sapna Patel, M.D. “I believe the results with anzu-cel presented today signal a much-needed breakthrough for patients with metastatic uveal melanoma. These findings highlight the potential of anzu-cel to redefine the treatment paradigm for uveal melanoma and bring new hope to patients who urgently need more effective options.” “Our goal is to leverage every opportunity to bring innovative PRAME therapies to patients with limited treatment options,” said Cedrik Britten, M.D., Chief Medical Officer at Immatics. “The continued strong clinical data presented today reinforce our conviction in maximizing the potential of our PRAME cell therapy, anzu-cel, and expanding its development into metastatic uveal melanoma, a rare cancer with very high unmet medical need. We are excited to further execute on our PRAME franchise and bring meaningful progress to patients in need.” Presidential Symposium III Presentation Summary – Anzu-cel Phase 1b Trial Patient Population: Difficult-to-treat patient population with metastatic uveal melanoma As of September 24, 2025, 16 patients with metastatic uveal melanoma were administered a one-time infusion of anzu-cel at the recommended Phase 2 dose (RP2D, 1 to 10 billion total TCR T cells) as part of the anzu-cel Phase 1b dose expansion. Patients received a median infused TCR T-cell dose of ~4 billion (range 1.62 - 8.43 billion TCR T cells) and had a median of 2 lines of prior systemic treatments. Patients had a median target lesion sum of a diameter of 103 mm (ranging from 31 to 210 mm), and 81% of patients had liver and extrahepatic metastasis. Anti-tumor Activity and Durability: Continued strong anti-tumor activity and durability of anzu-cel PRAME cell therapy Updated data of a one-time infusion of anzu-cel PRAME cell therapy demonstrated promising benefit in a difficult-to-treat population with limited effective treatment options: Confirmed objective response rate (cORR) of 67% (10/151)Disease control rate (DCR) of 88% (14/16)Median duration of response (mDOR) of 11 months (min 4.4, max 31.6 months)Median progression-free survival (mPFS) of 8.5 months (min 1.4, max 32.9) at a mFU of 10.4 months. The PFS rate was 69% at six months and 39% at 12 monthsMedian overall survival (mOS) not reached (min 4.3+, max 34.2+ months) at a mFU of 14.3 months. The OS rate was 71% at 12 months Anti-tumor activity was observed in liver and extrahepatic metastases, including lung, lymph node, abdomen/peritoneum and others. 14/16 patients had target lesions in the liver and treatment with anzu-cel led to a median shrinkage in liver target lesion size of 49.6%. Notably, 11 out of the 16 patients received a TCR bispecific (ten gp-100-targeting, one PRAME-targeting) as prior systemic treatment line, and thereof, six achieved a confirmed partial response, one a partial response and three stable disease. These results demonstrate anti-tumor activity of anzu-cel in patients who received prior TCR-based therapies. aPatient out of study at data cutoff (withdrew consent); BL, baseline; (c)PR, (confirmed) partial response; PD, progressive disease; SD, stable disease. aMaximum change of target lesions and RECIST1.1 response at different timepoints. bPatient off study at data cutoff date (withdrew consent). 14/16 patients had liver target lesions with median best change of longest diameter of liver target lesions (range) of -49.6% (-100, 10). BOR, best overall response; cPR, (confirmed) partial response; RECIST, Response Evaluation Criteria in Solid Tumors; SD, stable disease; PD, progressive disease. Safety: Favorable tolerability in uveal melanoma, generally consistent with full anzu-cel tolerability profile The most frequent treatment-emergent adverse events (TEAs) were anticipated cytopenias associated with lymphodepletion. Expected and manageable cytokine release syndrome (CRS) was mostly Grade 1 or 2, which is consistent with the mechanism of action (Grade 1: 37.5%, Grade 2: 43.8%, Grade 3: 18.8%, Grade 4: 0%). No patients experienced long-term CRS, and most CRS was resolved by day 14. No anzu-cel-related Grade 5 events were observed. Tolerability in the uveal melanoma subset was generally consistent with the full anzu-cel tolerability profile in the Phase 1b. Development Path for Anzu-cel in Metastatic Uveal Melanoma Based on the promising clinical data in patients with metastatic uveal melanoma, Immatics has initiated a Phase 2 cohort with approximately 30 uveal melanoma patients planned. The cohort is being conducted at select centers in the U.S. and Germany with deep expertise in uveal melanoma. Given the high prevalence of PRAME expression in uveal melanoma, prospective PRAME testing is no longer required for inclusion in the clinical trial. The consistent tolerability, anti-tumor activity and pharmacokinetic profile of anzu-cel across both uveal and cutaneous melanoma provide a strong rationale for pursuing a parallel late-stage development strategy to serve both patient populations. About PRAMEPRAME is a target expressed in more than 50 cancers. Immatics is the global leader in precision targeting of PRAME and has the broadest PRAME franchise with the most PRAME indications and modalities. The Immatics PRAME franchise currently includes three product candidates, two therapeutic modalities and a combination therapy that target PRAME: anzu-cel (IMA203) PRAME cell therapy, IMA203CD8 PRAME cell therapy (GEN2), IMA402 PRAME bispecific, anzu-cel in combination with Moderna’s PRAME cell therapy enhancer. About Anzu-cel (IMA203) PRAME Cell TherapyAnzu-cel (anzutresgene autoleucel; IMA203) is a PRAME-directed TCR T-cell therapy engineered to recognize an intracellular PRAME-derived peptide presented by HLA-A*02:01 on the cell surface and initiate a potent and specific anti-tumor response. Anzu-cel PRAME cell therapy is currently being evaluated in a registration-enabling randomized controlled Phase 3 trial, “SUPRAME,” in patients with unresectable or metastatic cutaneous melanoma who have disease progression on or after treatment with at least one checkpoint inhibitor. In parallel, the Phase 1b clinical trial in patients with PRAME cancers is ongoing with a focus on uveal melanoma. About ImmaticsImmatics is committed to making a meaningful impact on the lives of patients with cancer. We are the global leader in precision targeting of PRAME, a target expressed in more than 50 cancers. Our cutting-edge science and robust clinical pipeline form the broadest PRAME franchise with the most PRAME indications and modalities, spanning TCR T-cell therapies and TCR bispecifics. Immatics intends to use its website www.immatics.com as a means of disclosing material non-public information. For regular updates, you can also follow us on LinkedIn and Instagram. Forward-Looking StatementsCertain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or the Company’s future financial or operating performance. For example, statements concerning timing of data read-outs for product candidates, the timing, outcome and design of clinical trials, the nature of clinical trials (including whether such clinical trials will be registration-enabling), the timing of IND, CTA or BLA filings, estimated market opportunities of product candidates, the Company’s focus on partnerships to advance its strategy, and other metrics are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expect”, “plan”, “target”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Immatics and its management, are inherently uncertain. New risks and uncertainties may emerge from time to time, and it is not possible to predict all risks and uncertainties. Factors that may cause actual results to differ materially from current expectations include, but are not limited to, various factors beyond management's control including general economic conditions and other risks, uncertainties and factors set forth in the Company’s Annual Report on Form 20-F and other filings with the Securities and Exchange Commission (SEC). Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Company undertakes no duty to update these forward-looking statements. All the scientific and clinical data presented within this press release are – by definition prior to completion of the clinical trial and a clinical study report – preliminary in nature and subject to further quality checks including customary source data verification. For more information, please contact: MediaTrophic CommunicationsPhone: +49 151 74416179immatics@trophic.eu Immatics N.V.Jordan SilversteinHead of StrategyPhone: +1 346 319-3325InvestorRelations@immatics.com - END - 1Excluding one patient who withdrew consent with ongoing unconfirmed response. Attachment PDF Version