MAGEA3

近日，BioNTech 在2025年AACR大会上首次展示了mRNA疫苗BNT116联合cemiplimab（西米普利单抗，PD1）用于无法接受铂类化疗作为一线治疗的虚弱患者的初期临床研究数据。这项研究名为LuCa-MERIT-1，是一项开放标签、多组别的I期临床试验，致力于考察BNT116单药及其联合用药的疗效与安全性。在此次会上公布的数据集中在BNT116联合西米普利单抗的效果，特别针对不适合进行一线化疗且TPS ≥1%的患者。截至 2024年12月1日，共有20名患者参与了BNT116联合西米普利单抗的治疗方案。结果显示，所有患者都经历了一些与BNT116治疗相关的不良事件，其中13名（65%）的不良事件与西米普利单抗有关，而有3名（15%）患者出现了≥G3级的不良事件，这些事件与BNT116的使用有关，涉及症状包括心动过速、缺氧和高血压。另有2名（10%）患者的≥G3级不良事件仅与BNT116有关。严重不良事件在7名患者（35%）中出现，其中3名（15%）仅与BNT116有关，另外3名仅与西米普利单抗有关。此外，未发现致使患者死亡的不良事件。在疗效方面，数据显示，在接受治疗的 20位患者中，有9名（45%）实现了部分缓解（PR），另外有7名（35%）患者的疾病状态保持稳定。在部分缓解的9名患者中，有2名的PD-L1TPS小于50%。经过确认的客观缓解率为45%，而疾病控制率则达到了80%，同时，中位无进展生存期为9.9个月。ctDNA分析显示，患者在治疗的第3周便已有显著的分子应答反应。BNT116联合西米普利单抗治疗表现出在虚弱的晚期非小细胞肺癌患者中良好的抗肿瘤活性，并能持续引导免疫应答，且安全性可控。BNT116 是由 BioNTech 研制的一种通过静脉注射的未经修饰的 RNA-脂质体治疗性癌症疫苗。它由六种 mRNA 组成，包括CLDN6 、KK-LC-1、MAGE-A3、MAGE-A4、MAGE-C1 和 PRAME ，每种 mRNA 均在非小细胞肺癌中编码一种常见的肿瘤相关抗原（TAA）。识别微信二维码，可添加药时空小编请注明：姓名+研究方向！

来源：RNAScript近日，BioNTech 在2025年AACR大会上首次展示了mRNA疫苗BNT116联合cemiplimab（西米普利单抗，PD1）用于无法接受铂类化疗作为一线治疗的虚弱患者的初期临床研究数据。这项研究名为LuCa-MERIT-1，是一项开放标签、多组别的I期临床试验，致力于考察BNT116单药及其联合用药的疗效与安全性。在此次会上公布的数据集中在BNT116联合西米普利单抗的效果，特别针对不适合进行一线化疗且TPS ≥1%的患者。截至 2024年12月1日，共有20名患者参与了BNT116联合西米普利单抗的治疗方案。结果显示，所有患者都经历了一些与BNT116治疗相关的不良事件，其中13名（65%）的不良事件与西米普利单抗有关，而有3名（15%）患者出现了≥G3级的不良事件，这些事件与BNT116的使用有关，涉及症状包括心动过速、缺氧和高血压。另有2名（10%）患者的≥G3级不良事件仅与BNT116有关。严重不良事件在7名患者（35%）中出现，其中3名（15%）仅与BNT116有关，另外3名仅与西米普利单抗有关。此外，未发现致使患者死亡的不良事件。在疗效方面，数据显示，在接受治疗的 20位患者中，有9名（45%）实现了部分缓解（PR），另外有7名（35%）患者的疾病状态保持稳定。在部分缓解的9名患者中，有2名的PD-L1TPS小于50%。经过确认的客观缓解率为45%，而疾病控制率则达到了80%，同时，中位无进展生存期为9.9个月。ctDNA分析显示，患者在治疗的第3周便已有显著的分子应答反应。BNT116联合西米普利单抗治疗表现出在虚弱的晚期非小细胞肺癌患者中良好的抗肿瘤活性，并能持续引导免疫应答，且安全性可控。BNT116 是由 BioNTech 研制的一种通过静脉注射的未经修饰的 RNA-脂质体治疗性癌症疫苗。它由六种 mRNA 组成，包括CLDN6 、KK-LC-1、MAGE-A3、MAGE-A4、MAGE-C1 和 PRAME ，每种 mRNA 均在非小细胞肺癌中编码一种常见的肿瘤相关抗原（TAA）。免责声明：文章内容仅供参考，不构成投资建议。投资者据此操作，风险自担, 关于对文中陈述、观点判断保持中立，不对所包含内容的准确性、可靠性或完整性提供任何明示或暗示的保证。请读者仅作参考，并请自行承担全部。联系我们I-RNA 2025展位火热预定中！扫码立即咨询电话：13816031174（同微信）赞助形式包括但不仅限于演讲席位、会场展位、会刊彩页、晚宴赞助、会议用品宣传等。点击此处“阅读全文”咨询更多！

PDC*lung01, in combination with pembrolizumab, demonstrates the potential to provide meaningful clinical benefit compared to pembrolizumab alone in stage IV Non-Small Cell Lung Cancer patients with PD-L1 ≥ 50% and is associated with mild safety profile. Combination of high dose PDC*lung01 vaccine with pembrolizumab in 42 evaluable patients resulted in confirmed objective response rate of 55%, achieving predefined objective of trial, and median progression-free survival of 8.9 months. A higher immune response is significantly associated with better clinical outcomes (Progression-Free Survival) LIÈGE, Belgium & GRENOBLE, France I December 12, 2024 I PDC*line Pharma, a clinical-stage biotech company developing a new class of immunotherapies for cancers, presented the primary results of its phase I/II clinical trial for PDC*lung01, an innovative off-the-shelf therapeutic cancer vaccine, at the ESMO-IO 2024 conference today. PDC*lung01, when combined with pembrolizumab, demonstrated significant clinical benefits for stage IV Non-Small Cell Lung Cancer (NSCLC) patients with PD-L1 ≥ 50%, along with a mild safety profile. “PDC*lung01 in combination with anti-PD-1 showed a very promising and durable response as well as a significant immune response with indications of a relationship with clinical outcome in cohort B2. The data suggest that this combination could offer a clinically meaningful tumor response in stage IV NSCLC patients, along with a compelling safety profile,” said Prof Johan Vansteenkiste, emeritus professor in respiratory oncology at KU Leuven in Belgium and chair of the Data and Safety Monitoring Board. The phase I/II trial (PDC-LUNG-101, NCT03970746) evaluated the safety, tolerability, immunogenicity, and preliminary clinical activity of PDC*lung01 in NSCLC patients. The trial included 67 HLA-A02:01-positive NSCLC patients across five European countries. Patients received six weekly doses of PDC*lung01 through subcutaneous and intravenous administration. It assessed the vaccine in two doses both as a single agent (cohorts A1, A2 for stage II & IIIa NSCLC) and in combination with pembrolizumab (cohorts B1, B2 for stage IV NSCLC). Key clinical activity parameters, such as ORR and PFS, were analyzed in the B1 and B2 cohorts, with primary results reported from the high-dose, B2 cohort. With a database cut-off date on July 18, 2024, the patients’ median follow-up was 19.5 months (95% CI 13.8-25.6). Highlights: https://www.pdc-line-pharma.com/sites/default/files/images/2412PDC-LUNG-101-slides-ESMO-IO2024-final.pdf Further data from the trial will become available at the end of 2025, once all patients have reached two years of follow-up. Based on these very encouraging findings, PDC*line Pharma is preparing a randomized phase IIb study in untreated stage IV NSCLC (and PD-L1 ≥50%) in combination with pembrolizumab, with initiation planned in 2026. “We are thrilled by these promising results, which position PDC*lung01 as the first cancer vaccine of its kind tested in metastatic NSCLC with high PD-L1 expression. Its unique mechanism of action and favorable safety profile make it an excellent complement to pembrolizumab and other existing or emerging therapies for this patient population. Moreover, our off-the-shelf technology has significant potential for expansion into other clinical settings and indications. Our upcoming randomized Phase IIb trial is a critical step toward confirming clinical proof of concept and fostering collaborations with industrial partners to bring our innovative technology to market,” said Eric Halioua, CEO of PDC*line Pharma. About PDC*lung01: PDC*lung01 is an off-the-shelf cancer vaccine composed of irradiated human Plasmacytoid Dendritic Cells (PDC*line) loaded with peptides derived from key tumor antigens (NY-ESO-1, MAGE-A3, MAGE-A4, Multi-MAGE-A, MUC1, Survivin, Melan-A). These professional antigen-presenting cells prime and boost cytotoxic CD8+ T-cells, making the vaccine synergistic with checkpoint inhibitors like pembrolizumab. About PDC*line Pharma: Founded in 2014 as a spin-off of the French Blood Bank, PDC*line Pharma develops innovative cancer immunotherapies based on its proprietary PDC*line technology. The company focuses on PDC*lung01 for NSCLC and PDC*neo with neoantigens. It has raised more than €62M in equity and non-dilutive funding, and it collaborates with LG Chem for the development and commercialization of PDC*lung01 in Asia. The company’s off-the-shelf technology has potential applications across various cancer types and complements existing and emerging therapies. www.pdc-line-pharma.com SOURCE: PDC*line Pharma