Invasive Mammary Carcinoma

近日，华东医药股份有限公司（以下简称“公司”）全资子公司杭州中美华东制药有限公司（以下简称“中美华东”）收到国家药品监督管理局（NMPA）核准签发的《药物临床试验批准通知书》，由中美华东申报的HDM2006片临床试验申请获得批准，适应症为晚期实体瘤。 关于HDM2006片 HDM2006片是由中美华东自主研发的靶向HPK1（造血祖激酶 1）的新型、强效、高选择性、可口服吸收的蛋白降解靶向嵌合体（PROTAC）1类化学药品，中美华东拥有全球知识产权。临床前研究结果显示， HDM2006具有良好的成药性、安全性和有效性；HDM2006可特异性与人HPK1、E3连接酶结合形成三元复合物，进一步被泛素化和蛋白降解，从而解除HPK1对人T淋巴细胞、B淋巴细胞、DC细胞的负调控，激活免疫细胞、逆转肿瘤微环境中的免疫抑制和T细胞耗竭，进而发挥抗肿瘤作用；HDM2006在多个肿瘤模型中表现出显著的抗肿瘤效果，与PD-1/PD-L1抗体联用具有协同抗肿瘤作用。 2024年8月，中美华东向NMPA递交HDM2006片的临床试验申请获受理，并于近日获得NMPA批准，同意本品开展临床试验。 对公司的影响 HPK1（Hematopoietic Progenitor Kinase-1）是一种造血特异性蛋白丝氨酸－苏氨酸激酶，是哺乳动物Ste20相关蛋白激酶MAP4K家族的成员之一，在调节细胞存活、细胞迁移、细胞凋亡和自噬中发挥重要作用。HPK1主要在造血细胞和免疫细胞中表达，如造血祖细胞、T淋巴细胞、B淋巴细胞、树突状细胞（Dendritic cells，DC）等，是T细胞受体、B细胞受体和树突状细胞的负调节因子。HPK1激酶功能的丧失增加了细胞因子的分泌，增强了T细胞信号传导、病毒清除和肿瘤生长抑制。研究表明，HPK1的表达水平与多种肿瘤患者的生存时间呈负相关，如脑低级别胶质瘤、肾透明细胞癌、胰腺癌以及浸润性乳腺癌等。 本次HDM2006片临床试验获批，是该款产品研发进程中的重要里程碑，将进一步提升公司在肿瘤免疫治疗领域的核心竞争力。 未来，公司将持续秉承“以科研为基础，以患者为中心”的理念，以具有“临床价值、药物经济学价值、商业价值”为出发点，以临床需求和患者为先，依托于公司现有的研发平台加大生物药产品的研发投入，不断丰富创新管线，最终实现公司在创新药领域的差异化布局及领先的市场竞争力。 声明 1、本新闻旨在分享公司（或合作伙伴）研发工作的前沿进展资讯，非广告用途，相关信息并非针对患者，仅供医疗卫生专业人士参考使用； 2、本新闻稿中内容不涉及对任何药品和/或适应症作推荐； 3、本新闻稿中涉及的信息仅供参考，不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议。若您想了解具体疾病诊疗信息，请遵从医生或其他医疗卫生专业人士的意见或指导。 4、截止本文发布，HDM2006片尚未被国家药品监督管理局批准上市； 5、本新闻稿中可能会包含某些前瞻性表述。这些表述本质上具有相当风险和不确定性。在使用“预期”、“相信”、“预测”、“期望”、“打算”及其他类似词语进行表述时，凡与本公司有关的，均属于前瞻性表述。本公司并无义务不断地更新这些预测性陈述。 这些前瞻性表述是基于本公司管理层在做出表述时对未来事务的现有看法、假设、期望、估计、预测和理解。这些表述并非对未来发展的保证，会受到风险、不确性及其他因素的影响，有些是超出本公司的控制范围，难以预计。因此，受我们的业务、竞争环境、政治、经济、法律和社会情况的未来变化及发展的影响，实际结果可能会与前瞻性表述所含资料有较大差别。 本公司、本公司董事及雇员代理概不承担 (a) 更正或更新本网站所载前瞻性表述的任何义务;及 (b) 若因任何前瞻性表述不能实现或变成不正确而引致的任何责任。

Roche’s PI3K inhibitor Itovebi (inavolisib) has been approved by the US Food and Drug Administration (FDA) as part of a combination treatment for advanced breast cancer. The drug has been authorised for use alongside Pfizer’s CDK4/6 inhibitor Ibrance (palbociclib) and fulvestrant hormone therapy to treat adults with endocrine-resistant, PIK3CA-mutated, hormone receptor (HR)-positive, human epidermal growth factor receptor 2-negative, locally advanced or metastatic breast cancer. The FDA’s decision was supported by positive results from the late-stage INAVO120 study, in which the Itovebi-based regimen reduced the risk of disease worsening or death by 57% compared with Ibrance and fulvestrant alone in the first-line setting. Overall survival (OS) data was immature at the time of primary analysis, but a “clear positive trend” was observed with the triplet therapy, Roche said, adding that OS will continue to be assessed. Approximately 310,720 women are expected to be diagnosed with invasive breast cancer in the US this year. HR-positive breast cancer is the most common subtype of the disease and PIK3CA mutations, which have been linked to tumour growth, disease progression and treatment resistance, are found in approximately 40% of HR-positive metastatic breast cancers. Roche said that Itovebi will be available in the US in the coming weeks, adding that results from INAVO120 are also being submitted to other global health authorities, including the European Medicines Agency. The company’s chief medical officer and head of global product development, Levi Garraway, said: “With the approval of this Itovebi-based regimen, we continue our long-standing track record of cancer therapeutic discovery by offering an important new first-line option for people living with HR-positive breast cancer with a PIK3CA mutation. “Despite the high prevalence of PIK3CA mutations in this setting, treatment options have thus far remained limited, which makes [this] approval all the more significant.” The authorisation comes less than a month after the FDA approved Roche’s injectable monoclonal antibody Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq) to treat both relapsing and primary progressive multiple sclerosis. The company was also recently granted breakthrough device designation by the US regulator for its Alzheimer’s disease blood test Elecsys pTau217, which is being developed in collaboration with Eli Lilly.

TUESDAY, Oct. 1, 2024 -- While women overall are less likely to die of breast cancer now, some alarming disparities remain, a new American Cancer Society (ACS) analysis warns. Death rates for American Indian and Alaska Native women haven't changed for the past 30 years, according to the new report. And breast cancer incidence continues to grow -- rising 1% a year between 2012-2021. The biggest increases were among women under 50 (1.4% a year) and Asian American/Pacific Islander women of any age (2.5%-2.7% per year). "These gaps need to be rectified through systematic efforts to ensure access to high-quality screening and treatment for every woman," said Dr. William Dahut , chief scientific officer for the ACS. Overall, death rates due to breast cancer have dropped 44% since 1989, saving about 517,900 lives since that time, the ACS estimates. However, breast cancer remains the leading cause of cancer death in Hispanic women and is second only to skin cancer among all U.S. women. The findings are reported in Breast Cancer Statistics 2024, the cancer society's biennial update on U.S. breast cancer trends. They were published Oct. 1 in CA: A Cancer Journal for Clinicians . "The encouraging news is breast cancer [death] rates continue to decrease, thanks to advances in early detection and treatment," said lead study author Angela Giaquinto , an associate scientist at the ACS. "But future progress may be thwarted by increasing incidence, especially among younger women, and consequences of the COVID-19 pandemic, such as delayed diagnosis due to interruptions in screening," she added in an ACS news release. Researchers project that 310,720 new cases of invasive breast cancer will be diagnosed in the United States this year and that 42,250 women will die from the disease. They also project that 2,790 men will receive a breast cancer diagnosis and 530 will die. Other takeaways: "Building upon the progress we have made in reducing breast cancer [death] rates requires ensuring more individuals have access to cancer screenings," said Lisa Lacasse , president of the American Cancer Society Action Network. She called on Congress to pass the Screening for Communities to Receive Early and Equitable Needed Services (SCREENS) for Cancer Act. It would reauthorize a nationwide program for early detection of breast and cervical cancer and expand its reach to more people who might otherwise not be screened. Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.