Trastuzumab

临床试验资讯研究交流群（点击） 恶性肿瘤治疗还是要看免疫治疗，而不是每一个患者都能从PD-1抑制剂获益，最近兴起的肿瘤浸润淋巴细胞治疗（TILS），以及癌症治疗疫苗让大家重新燃起对肿瘤治疗的期望。癌度将最近刊登的一篇文献编译一下，看看目前对于乳腺癌来说，最近的癌症治疗疫苗有什么临床研究，治疗的效果和预期是什么？ 本文参考文献刊例示意图 一、为什么晚期乳腺癌患者要使用“疫苗”的治疗？ 对于乳腺癌来说，常规疗法（外科手术、放化疗、内分泌药物、靶向药和PD-1抑制剂等）可明显提高局限期乳腺癌患者的预后，但对于复发或转移性乳腺癌来说仍不够让人满意。今天我们癌度给大家着重接受癌症治疗疫苗，癌症治疗疫苗的目的在于活化或使免疫系统对特定的肿瘤抗原进行长期的识别和杀灭，所以理论上： 由于肿瘤细胞有与正常细胞不一样的特别抗原，癌症治疗疫苗可以增强免疫细胞对特定肿瘤抗原的免疫记忆； 联合其他免疫治疗药物，如PD-1/PD-L1抑制剂等，可打破肿瘤的免疫耐受； 癌症治疗疫苗属于免疫治疗，患者治疗的总体是耐受的，因此使用癌症治疗疫苗可以实现持久的病情控制。 所以，很多临床研究集中在针对已经发生转移和复发的晚期乳腺癌的治疗上，对于这部分患者使用癌症治疗疫苗能不能让患者获益。 图片来自：摄图网 二、目前的临床试验告诉了我们什么？ 癌度今天给大家介绍的内容，属于一项包括了19项临床试验，747例晚期/转移性乳腺癌综合分析，研究的结果如下： ① 目前的乳腺癌治疗疫苗的临床研究主要集中在早期（一期或二期），几乎没有三期随机对照的临床试验。 ② 临床试验主要采用开放标签、单臂或小样本的随机对照临床试验，主要探索使用癌症治疗疫苗之后的患者体内的一些免疫指标，以及对患者生存时间的改善。 ③ 疫苗的种类多样，包括肽疫苗、树突状细胞疫苗、全细胞/细胞裂解物疫苗、病毒载体疫苗及糖类疫苗等。在不同的癌症治疗疫苗，自然相关的免疫学指标和临床指标存在很大的差别。所以也没办法说谁更好。 ④ 大部分临床试验均能诱发出明显的 免疫T细胞或抗体的应答，患者体内出现免疫反应率的范围为44%~100%。 ⑤ 少数临床研究显示了一些喜人的趋势，如癌症疫苗与化疗、曲妥珠单抗或免疫检查点抑制剂联合可以显著提高疾病控制率，延长无进展生存期。 ⑥ 大多数癌症疫苗的副反应以注射部位反应、发热和乏力为主（1-2级）；整体的耐受性较好，因癌症疫苗而停药的情况较少。 总结一下， 疫苗的种类很多，所以结果无可比性，初步结果显示有希望，但临床试验证据不够充分，需要大型三期临床试验验证。 来自：摄图网 三、目前19项临床试验给到的启示 癌症治疗疫苗大部分是安全的，并且能够引起免疫应答，但是“激发免疫”并不总是意味着“使肿瘤消失或存活时间更长”。目前看总体获益的病人不是很多。 1、哪些患者最有可能从中获益？ 现有研究结果表明，部分亚型（例如HER2阳性乳腺癌、特定免疫微环境）使用癌症疫苗的治疗效果更佳，但缺乏统一的标准筛选谁最可能受益。  2、什么时候可以考虑癌症疫苗？ 肿瘤治疗疫苗还在临床试验阶段。对于晚期乳腺癌病人来说，参加就要选择规范化的临床试验，着重看癌症治疗疫苗的治疗机制，不是每一个癌症治疗疫苗的临床试验都值得参加。  3、未来的治疗方向很明确 开展更多规模的三期 临床试验，将癌症治疗疫苗与其他药物联合，如免疫检查点抑制剂，靶向药或小剂量化疗。更加个性化的癌症治疗疫苗可能会更好，如果基于肿瘤基因突变设置的mRNA治疗疫苗。 四、耐心地等待，癌症治疗疫苗来证实自己 癌症疫苗是一种极具吸引力的免疫疗法：它能激发患者身体的免疫系统对癌细胞进行长期的免疫监视。目前的研究结果表明该方法是有效的和安全的，但是还没有大型三期临床试验证实有效性，或直接批准为临床用药。但是对于所有治疗方法用过之后的患者，参加癌症疫苗联合其他药物的组合用药临床试验是值得的。也欢迎大家联系癌度参加筛选适合您的临床试验！ 关注癌度，了解全球肿瘤诊疗的最新进展！ （咨询癌度请扫描下面图片二维码） 参考文献： Anna Charalampopoulou, et al., A systematic review of the efficacy of cancer vaccines in advanced breast cancer, breast cancer,2025.  往期推荐  体内建造“抗癌兵工厂”：科学家成功改造干细胞，源源不断生成抗癌斗士 别再误解双抗了！常见误区 “扫雷”+答疑指南，肺癌患者必看 解锁大自然的抗癌“工具包”，绿茶、白藜芦醇、红酒和姜黄皆入选, 一文解读它们如何辅助癌症治疗？ “从无到有”，常规基因检测没有任何突变，换用RNA测序能找出87%的突变！

STAFFORD, Texas, Aug. 11, 2025 (GLOBE NEWSWIRE) -- Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GLSI-100, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, today provided the following update on CEO interviews and corporate events. The following videos, which include CEO interviews, are now available on the Company’s website at the bottom of the Welcome page: https://greenwichlifesciences.com/ Jun 28, 2025 – Interview on Bloomberg TV (recorded April 2025)Jun 4, 2025 – Live Fireside Chat with Research Analyst at Noble Virtual ConferenceApr 29, 2025 – Live Interview on Charles Schwab Network with Diane King HallIntroductory Video The Company's recent prior events are listed below: Nov 19 - 21, 2024 – Jefferies London Healthcare ConferenceDec 10 - 13, 2024 – San Antonio Breast Cancer Symposium (SABCS) with Flamingo-01 Poster, Booth, & Conference Room Dec 19, 2024 – Annual Meeting of StockholdersFeb 10 - 11, 2025 – BIO CEO & Investor ConferenceMar 6 - 7, 2025 – German Breast Group Annual Scientific MeetingMay 14 - 16, 2025 – ESMO Breast Conference in Germany with Flamingo-01 Poster & BoothMay 20, 2025 – H.C. Wainwright 3rd Annual BioConnect Investor Conference at NasdaqJun 2, 2025 – American Society of Clinical Oncology (ASCO) with Flamingo-01 PosterJun 4, 2025 – Noble Emerging Growth Virtual ConferenceJun 5, 2025 – Jefferies Global Healthcare ConferenceJun 16 - 19, 2025 – BIO International Convention (partnering conference) About FLAMINGO-01 and GLSI-100 FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients will be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types will be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater. For more information on FLAMINGO-01, please visit the Company's website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the "Contacts and Locations" section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: flamingo-01@greenwichlifesciences.com About Breast Cancer and HER2/neu Positivity One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. About Greenwich LifeSciences, Inc. Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company's website at www.greenwichlifesciences.com and follow the Company's Twitter at https://twitter.com/GreenwichLS. Forward-Looking Statement Disclaimer Statements in this press release contain "forward-looking statements" that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.'s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled "Risk Factors" in Greenwich LifeSciences' Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law. Company ContactSnehal PatelInvestor RelationsOffice: (832) 819-3232Email: info@greenwichlifesciences.com Investor & Public Relations Contact for Greenwich LifeSciencesDave GentryRedChip Companies Inc.Office: 1-800-RED CHIP (733 2447)Email: dave@redchip.com