Ensartinib Hydrochloride

Dr. Selvaggi was instrumental in the development and approval of lung cancer drugs Zykadia for Novartis and Opdivo for Bristol Myers Squibb CEL-SCI’s Multikine immunotherapy improves the 5-year survival of head and neck cancer patients to 73% compared to 45% in controls and cuts the 5-year risk of death by 50% FDA has given CEL-SCI the go-ahead to commence a confirmatory Registration Study for Multikine for the target population in head and neck cancer Dr. Selvaggi will be supporting CEL-SCI to bring Multikine to patients through a confirmatory registrational path that has been agreed with regulatory authorities and that has a potential for cure VIENNA, Va.--(BUSINESS WIRE)-- CEL-SCI Corporation (NYSE American: CVM) today announced Dr. Giovanni Selvaggi, an oncology key opinion leader instrumental in successfully bringing several drugs to market has joined CEL-SCI as a Clinical Advisor. Dr. Selvaggi joins CEL-SCI as the Company recently received its go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of head and neck cancer. This press release features multimedia. View the full release here: (Graphic: Business Wire) Multikine is the first investigational pre-surgical cancer drug in newly diagnosed head and neck cancer. Multikine is a copy of the pro-inflammatory cytokine immune response human bodies produce every day and is designed to empower a person’s intact immune system cells to attack their own cancer. Patients are treated with Multikine right after diagnosis, before any other standard of care treatment (surgery and radiation therapy) since that is when the immune system is strongest. There is robust safety and efficacy data from 750 patients who have been treated with Multikine. Based on the following efficacy data, the FDA has agreed to CEL-SCI’s 212-person Registration Study to confirm the findings for regulatory approval: No safety signals vs standard of care 73% survival for Multikine vs 45% in the control arm at 5 years Statistically significant p = 0.0015 5-year risk of death cut in half from 55% to 27% (Hazard ratio = 0.35 (95% CIs [0.19, 0.66]) More detailed results may be viewed here: LINK Dr. Selvaggi is a US-based drug developer, cancer researcher, and strategic advisor to big pharma and early-to-late stage biotech companies. He is currently Chief Medical Officer at Xcovery Holdings, where he manages an ongoing New Drug Application with the FDA for ensartinib, an ALK-TKI for non-small cell lung cancer (NSCLC). He is also a Clinical Consultant to Tubulis GmBH for a first-in-class ADC program in solid tumors, and Clinical Strategy Senior Advisor to Alira Health. He formerly served as Medical Director, Cancer Immunotherapy, in the MAGE-A3 lung cancer vaccine program at GSK. Later, Dr. Selvaggi played an instrumental role in the successful development and approval of ceritinib (Zykadia) in ALK-translocated NSCLC at Novartis. At Oncolytics he was VP of Clinical Development. Most recently, Dr. Selvaggi was part of the immunotherapy team at Bristol-Myers Squibb, serving as a program lead in thoracic malignancies, with a focus on SCLC and mesothelioma, leading to the approval of nivolumab (Opdivo) in third line small cell lung cancer. Dr. Selvaggi received his medical degree at the University of Torino School of Medicine, in Torino, Italy, and served as staff physician of thoracic oncology at the University Hospital in Torino, participating in several clinical trials in lung cancer and mesothelioma over a span of 20 years. Dr. Selvaggi commented, “Multikine is a first in class immunotherapy that has demonstrated to meaningfully and safely prolong survival in a selected orphan population of newly diagnosed head and neck cancer. The importance of tackling cancer at the earliest stages to guarantee the most relevant impact in patients’ lives is undeniable, especially in head and neck cancer which has no approved therapeutic options before surgery. I am fully committed to supporting CEL-SCI leadership to bring this asset to patients through an expedited registrational path that has been agreed with regulatory authorities and that has a potential for cure.” “Dr. Selvaggi has a passion for bringing cancer drugs to market to save lives and lead clinical research toward a cure for cancer. We are excited to have him join CEL-SCI as a Clinical Advisor at this pivotal point for Multikine which is set to commence a confirmatory FDA Registration Study,” stated CEL-SCI CEO, Geert Kersten. “The data on Multikine is excellent, and as we proceed with and wrap up this final study, Dr. Selvaggi’s experience and successful track record in navigating late-stage development, clinical trials, and the regulatory approval process will be hugely valuable for us.” Dr. Selvaggi joins several other top-tier physician consultants and head and neck cancer key opinion leaders who are advisors to CEL-SCI. About CEL-SCI Corporation CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI’s target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually. The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland. Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use. View source version on businesswire.com: Contacts Gavin de Windt CEL-SCI Corporation (703) 506-9460 Source: CEL-SCI Corporation Smart Multimedia Gallery Photo (Graphic: Business Wire) Logo View this news release and multimedia online at:

关注并星标CPHI制药在线 2024 ASCO会议已顺利结束，今年据称约有44,000人聚集在美国芝加哥参加会议，这个数字远超去年的30,000人。在今年的ASCO会议上，实体瘤治疗迎来了有望载入史册的突破。 晚期NSCLC单药分子靶向治疗中最长的PFS 在转移性非小细胞肺癌（NSCLC）口头报告专场，辉瑞公布了III期CROWN研究的长期随访结果。该研究旨在评估洛拉替尼vs克唑替尼治疗ALK阳性晚期NSCLC初治患者的5年无进展生存期（PFS）和安全性。 既往中期分析显示，中位随访18.3个月，洛拉替尼组的中位PFS尚未达到，克唑替尼组为9.3个月（HR=0.28，P<0.001）。本次报道截至2023年10月31日的5年事后分析结果。 在这项III期CROWN研究5年分析中，中位随访60.2个月时，研究者评估的洛拉替尼组中位PFS仍尚未达到，对比克唑替尼组的中位PFS为NR vs 9.1个月，5年PFS率为60% vs 8%，也就是说60%的患者在五年后仍未发生疾病进展或死亡，这个数字在晚期肺癌领域史无前例，这是迄今为止晚期NSCLC单药分子靶向治疗中最长的PFS。该口头报告赢得了所有人的掌声。 而且在颅内疗效方面，无论患者基线是否存在脑转移，洛拉替尼均带来显著更优的PFS：洛拉替尼组 vs 克唑替尼组的中位PFS为NR vs 6.0个月（HR=0.08）；同时，洛拉替尼组至颅内进展的时间也较克唑替尼组更长，ITT人群中分别为NR vs 16.4个月（HR=0.06）；在基线无脑转移的患者中，接受洛拉替尼治疗的114例患者中仅有4人在治疗最初的16个月内出现脑转移，而接受克唑替尼治疗的109例患者中有39例出现这一情况。说明洛拉替尼具有很好的脑转移预防作用。安全性方面，洛拉替尼与既往分析中观察到的一致。 CROWN研究被称为有望载入史册的突破，肺癌领域的全球治疗格局或有望就此改写。 三代同堂的ALK抑制剂，持续迭代 洛拉替尼是辉瑞公司研发的第三代ALK抑制剂，它具有独特的环状结构，更容易穿透血脑屏障，并且可以抑制ALK靶点的耐药突变。洛拉替尼目前已获NMPA批准，用于ALK阳性的局部晚期或转移性NSCLC患者的治疗。 ALK（间变性淋巴瘤激酶）阳性是NSCLC的一种驱动基因突变，2007年，ALK融合基因首次被发现并证实为肺癌驱动基因，成为NSCLC的一个重要靶点。ALK阳性NSCLC约占全部NSCLC的3%-7%，由于患者基数庞大，ALK阳性NSCLC虽然占比不高，但每年新发病例数仍不容忽视。由于ALK阳性NSCLC患者使用相应的靶向药可以获得很好的疗效和更长的生存期，因此ALK融合基因突变又被称之为"钻石突变"。 目前已有三代ALK抑制剂上市，约有十款产品获批。其中克唑替尼（Crizotinib）是最早上市的ALK抑制剂，于2011年获FDA快速批准上市，2013年在中国获批上市。尽管与铂类化疗相比，克唑替尼疗效显著，但是经克唑替尼治疗的患者一般在12个月内会出现耐药现象，而且由于克唑替尼血脑屏障通过率低下，多数患者治疗复发后出现脑转移（50%）。 为了克服这些不足，第二代ALK抑制剂横空出世。目前已有阿来替尼（Alectinib）、布格替尼（Brigatinib）、塞瑞替尼（Ceritinib）、恩沙替尼（Ensartinib）获批上市，他们与ALK位点的亲和力及血脑屏障通过性均有明显提高，但是仍存在脑转移和耐药问题。 关键时刻，三代ALK抑制剂登场。第三代药物洛拉替尼（Lorlatinib）具有独特的分子结构，具有更高的选择性和更强的中枢神经系统（CNS）渗透性，在第一、二代药物治疗失败的情况下，仍具有抗肿瘤活性。同时洛拉替尼入脑效果较强，特别适合对其他ALK抑制剂耐药的晚期NSCLC患者。 2018年，洛拉替尼已在美国和日本获批上市，2019年在欧洲获批上市；2021年3月，FDA批准洛拉替尼用于ALK阳性NSCLC一线治疗。 如今ALK抑制剂已经迭代至第三代产品，给患者带来了更多选择。国内药企对ALK抑制剂的研发也充满激情。目前，已经有两款国产ALK创新药上市，分别是贝达药业的恩沙替尼和齐鲁制药的伊鲁阿克（商品名：启欣可）。同时，首药控股的第三代ALK抑制剂Ficonalkib也正处于上市前夕。 在三代ALK抑制剂如日中天的时候，第四代药物呼之欲出。 NVL-655 是由 Nuvalent 公司开发的一种第四代ALK-TKI。NVL-655兼顾了抗ALK 活性、脑渗透性、可避免TRK相关的神经毒性，用来应对第三代ALK-TKI 的耐药。体外研究显示，NVL-655对ALK 融合及其耐药突变具有强效的抑制作用。 目前已在针对ALK耐药NSCLC患者的I期试验中取得积极数据。研究结果显示：ORR 为 39%（20/51），中位治疗持续时间 3.4 个月，中位反应时间为 6.1 周。在安全性方面，NVL-655 耐受性良好，治疗相关不良事件较轻。 不完全统计，目前国内在研ALK抑制剂有十余款，希望在新一代ALK抑制剂的帮助下， 有更多患者能够跨过一个个5年生存大关。 主要参考资料：        1、Pan Yue, Deng Chao, Qiu Zhenhua, et al. The Resistance Mechanisms and Treatment Strategies for ALK-Rearranged Non-Small Cell Lung Cancer[J]. Front Oncol, 2021, 11: 713530.        2、Benjamin J. Solomon, et al. Lorlatinib vs crizotinib in treatment-na?ve patients with advanced ALK+ non-small cell lung cancer: 5-year progression-free survival and safety from the CROWN study. 2024 ASCO LBA8503.        3、Desai Aakash, Lovly Christine M. Strategies to overcome resistance to ALK inhibitors in non-small cell lung cancer: a narrative review[J]. Transl Lung Cancer Res, 2023, 12: 615-628. 【企业推荐】 【智药研习社直播预告】 来源：CPHI制药在线 声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。 投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~