Saruparib

氨基观察-创新药组原创出品 作者 | 黄恺 mRNA肿瘤疫苗的重磅节点，可能近了。 3月5日，Moderna在投资者会议上表示，该公司有望于2027年推出首个mRNA肿瘤疫苗V940。 安进继续押注减肥药。 3月5日，据全球临床试验收录网站clinicaltrials，安进启动了AMG 133的两项减重III期临床试验，标志着AMG 133进入III期开发阶段。 京东健康发布成绩单，营收、利润增速均低于10% 3月6日，京东健康发布2024年全年业绩公告。2024年公司总收入为人民币582亿元，同比增速8.6%；非国际财务报告准则指标下（Non-IFRS）净利润47.9亿元，同比增长4.9%。 在过去的一天里，国内外医药市场还有哪些热点值得关注？让氨基君带你一探究竟。 / 01 / 资本信息 1）京东健康营收、利润增速均低于10% 3月6日，京东健康发布2024年全年业绩公告。2024年公司总收入为人民币582亿元，同比增速8.6%；非国际财务报告准则指标下（Non-IFRS）净利润47.9亿元，同比增长4.9%。 / 02 / 医药动态 1）和誉医药ABSK131胶囊获临床许可 3月6日，据CDE官网，誉医药ABSK131胶囊获临床许可，拟开展治疗晚期/转移性实体瘤的研究。 2）神州细胞SCTT11注射液获临床许可 3月6日，据CDE官网，神州细胞SCTT11注射液获临床许可，拟开展治疗甲状腺眼病的研究。 3）联馨药业SAR107375E片获临床许可 3月6日，据CDE官网，联馨药业SAR107375E片获临床许可，拟用于预防深静脉血栓形成。 4）阿斯利康Baxdrostat片获临床许可 3月6日，据CDE官网，阿斯利康Baxdrostat片获临床许可，拟联合达格列净用于降低心力衰竭高风险患者的心血管死亡和心力衰竭的风险。 5）魁特迪生物注射用QD202获临床许可 3月6日，据CDE官网，魁特迪生物注射用QD202获临床许可，拟开展治疗缺血性脑卒中的研究。 6）民为生物MWN105注射液获临床许可 3月6日，据CDE官网，民为生物MWN105注射液获临床许可，拟开展治疗缺血性脑卒中的研究。 7）凡恩世PT886获临床许可 3月6日，据CDE官网，凡恩世PT886获临床许可，拟开展治疗晚期实体瘤的研究。 8）寻百会生物GV20-0251注射液获临床许可 3月6日，据CDE官网，寻百会生物GV20-0251注射液获临床许可，拟开展治疗晚期实体瘤的研究。 9）核新生物XY003片获临床许可 3月6日，据CDE官网，核新生物XY003片获临床许可，拟开展治疗晚期实体瘤的研究。 10）泰比棣医药注射用TPD3310获临床许可 3月6日，据CDE官网，泰比棣医药注射用TPD3310获临床许可，拟用于标准治疗失败、不耐受标准治疗或缺乏有效标准治疗的MET异常的晚期恶性实体瘤患者的治疗。 11）阿斯利康AZD5305获临床许可 3月6日，据CDE官网，阿斯利康AZD5305获临床许可，拟联合AZD5305联合或不联合 AZD2936用于治疗晚期或转移性实体恶性肿瘤。 12）云顶新耀mRNA个性化肿瘤治疗性疫苗EVM16完成首例患者给药 3月6日，云顶新耀宣布，自主研发的首款新型mRNA个性化肿瘤治疗性疫苗EVM16已在北京大学肿瘤医院顺利完成首例患者给药，标志着此项临床试验项目的里程碑进展。 13）双鹭药业注射用重组人促卵泡激素未获批准 3月6日，据NMPA官网，双鹭药业注射用重组人促卵泡激素收到药品通知件，意味着未获批准。 / 03 / 器械跟踪 1）维力医疗产品获得美国FDA批准注册 3月6日，维力医疗公告，维力浸水式间歇性导尿管、维力预润滑间歇性导尿管获得美国FDA批准注册。 2）微创脊柱椎板固定板系统获注册许可 3月6日，据NMPA官网，微创脊柱椎板固定板系统获注册许可。 3）微创医疗冠脉雷帕霉素靶向洗脱支架系统获注册许可 3月6日，据NMPA官网，微创医疗冠脉雷帕霉素靶向洗脱支架系统获注册许可。 4）迈瑞生物彩色多普勒超声诊断系统获注册许可 3月6日，据NMPA官网，迈瑞生物彩色多普勒超声诊断系统获注册许可。 5）科曼医疗半自动体外除颤器获注册许可 3月6日，据NMPA官网，科曼医疗半自动体外除颤器获注册许可。 6）东软医疗X射线计算机体层摄影设备获注册许可 3月6日，据NMPA官网，东软医疗X射线计算机体层摄影设备获注册许可。 7）瑞龙诺赋胸腹腔内窥镜手术器械控制系统获注册许可 3月6日，据NMPA官网，瑞龙诺赋胸腹腔内窥镜手术器械控制系统获注册许可。 8）柳叶刀机器人口腔种植手术导航设备获注册许可 3月6日，据NMPA官网，柳叶刀机器人口腔种植手术导航设备获注册许可。 / 04 / 数字医疗日报 1）医准医疗乳腺超声影像辅助检测软件获注册许可 3月6日，据NMPA官网，医准医疗乳腺超声影像辅助检测软件获注册许可。 / 05 / 海外药闻 1）首个肿瘤mRNA疫苗有望在2027年推出 3月5日，Moderna在投资者会议上表示，该公司有望于2027年推出首个mRNA肿瘤疫苗V940。 2）安进AMG 133启动减重III期临床 3月5日，据全球临床试验收录网站clinicaltrials，安进启动了AMG 133的两项减重III期临床试验，标志着AMG 133进入III期开发阶段。 PS：欢迎扫描下方二维码，添加氨基君微信号交流。

First and only next-generation oral SERD and complete ER antagonist to demonstrate 1st-line benefit in combination with widely approved CDK4/6 inhibitors LONDON, UK I February 26, 2025 I Positive high-level results from a planned interim analysis of the SERENA-6 Phase III trial showed that AstraZeneca’s camizestrant in combination with a cyclin-dependent kinase (CDK) 4/6 inhibitor (palbociclib, ribociclib or abemaciclib) demonstrated a highly statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS). The trial evaluated switching to the camizestrant combination versus continuing standard-of-care treatment with an aromatase inhibitor (AI) (anastrozole or letrozole) in combination with a CDK4/6 inhibitor in the 1st-line treatment of patients with hormone receptor (HR)-positive, HER2-negative advanced breast cancer whose tumours have an emergent ESR1 mutation. The key secondary endpoints of time to second disease progression (PFS2) and overall survival (OS) were immature at the time of this interim analysis. However, the camizestrant combination demonstrated a trend toward improvement in PFS2. The trial will continue as planned to further assess key secondary endpoints. SERENA-6 is the first global, double-blind, registrational Phase III trial to use a circulating tumour DNA (ctDNA)-guided approach to detect the emergence of endocrine resistance and inform a switch in therapy before disease progression. The novel trial design used ctDNA monitoring at the time of routine tumour scan visits to identify patients for early signs of endocrine resistance and the emergence of ESR1 mutations. Following detection of an ESR1 mutation without disease progression, the endocrine therapy of patients was switched to camizestrant from ongoing treatment with an AI, while continuing combination with the same CDK4/6 inhibitor. François-Clément Bidard, MD, PhD, Professor of Medical Oncology at Institut Curie & UVSQ/Université Paris-Saclay, France, and co-principal investigator for the trial, said: “Patients have an urgent need for new treatments that delay disease progression on 1st-line endocrine-based therapies. The results from SERENA-6 show that switching from an aromatase inhibitor to camizestrant in combination with any of the three CDK4/6 inhibitors after emergence of an ESR1 mutation delays progression of disease and extends the benefit of 1st-line treatment, representing an important step forward for patients, and a potential shift in clinical practice.” Susan Galbraith, Executive Vice President, Oncology Haematology R&D, AstraZeneca, said: “These impressive results demonstrate the versatility of camizestrant in combination with all the widely approved CDK4/6 inhibitors to provide a well-tolerated new potential treatment option in the first-line setting for the one in three patients with HR-positive, HER2-negative advanced breast cancer whose tumours develop ESR1 mutations during treatment with an aromatase inhibitor in combination with a CDK4/6 inhibitor. This critical read-out moves us one step closer to realising the potential of camizestrant to become a new standard-of-care as we look to shift the treatment paradigm and establish this new endocrine therapy backbone in HR-positive breast cancer.” The safety profile of camizestrant in combination with palbociclib, ribociclib or abemaciclib in SERENA-6 was consistent with the known safety profile of each medicine. No new safety concerns were identified and discontinuations were very low and similar in both arms. Globally, approximately 200,000 patients with HR-positive breast cancer are treated with a medicine in the 1st-line setting; most frequently with endocrine therapies that target estrogen receptor (ER)-driven disease, which are often paired with CDK4/6 inhibitors. 1-3 However, resistance to CDK4/6 inhibitors and current endocrine therapies develops in many patients with advanced disease. 3 Mutations in the ESR1 gene are a key driver of endocrine resistance and are widely tested for in clinical practice. 4,5 Thesemutations develop during treatment of the disease, becoming more prevalent as the disease progresses and are associated with poor outcomes. 4,5 Approximately 30% of patients with endocrine sensitive HR-positive disease develop ESR1 mutations during 1st-line treatment without disease progression. 1 Data will be presented at a forthcoming medical meeting and shared with global regulatory authorities. Notes HR-positive breast cancer Breast cancer is the second most common cancer and one of the leading causes of cancer-related deaths worldwide. 6 More than two million patients were diagnosed with breast cancer in 2022, with more than 665,000 deaths globally. 6 While survival rates are high for those diagnosed with early breast cancer, only about 30% of patients diagnosed with or who progress to metastatic disease are expected to live five years following diagnosis. 7 HR-positive breast cancer, characterised by the expression of estrogen or progesterone receptors, or both, is the most common subtype of breast cancer with 70% of tumours considered HR-positive and HER2-negative. 7 ERs often drive the growth of HR-positive breast cancer cells. 8 Once resistance to the treatment of HR-positive breast cancer with CDK4/6 inhibitors and current endocrine therapies occurs, treatment options are limited and survival rates are low with 35% of patients anticipated to live beyond five years after diagnosis. 3,7,9 The optimisation of endocrine therapy and overcoming resistance to enable patients to continue benefiting from these treatments, as well as identifying new therapies for those who are less likely to benefit, are active areas of focus for breast cancer research. SERENA-6 SERENA-6 is a Phase III, double-blind, randomised trial evaluating the efficacy and safety of camizestrant in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib ) versus treatment with an AI (anastrozole or letrozole) in combination with a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib) in patients with HR-positive, HER2-negative advanced breast cancer (patients with either locally advanced disease, or metastatic disease) whose tumours have an emergent ESR1 mutation. The global trial enrolled 315 adult patients with histologically confirmed HR-positive, HER2-negative advanced breast cancer, undergoing treatment with an AI in combination with a CDK4/6 inhibitor as 1st-line treatment. The primary endpoint of the SERENA-6 trial is PFS as assessed by investigator, with secondary endpoints including OS, and PFS2 by investigator assessment. Camizestrant Camizestrant is an investigational, potent, next-generation oral selective estrogen receptor degrader (SERD) and complete ER antagonist that is currently in Phase III trials for the treatment of HR-positive breast cancer. AstraZeneca’s broad, robust and innovative clinical development programme, including the SERENA-6, SERENA-4, CAMBRIA-1 and CAMBRIA-2 trials, is evaluating the safety and efficacy of camizestrant when used as a monotherapy or in combination with other agents to address a number of areas of unmet need in this specific type of breast cancer. Camizestrant has demonstrated anti-cancer activity across a range of preclinical models, including those with ER-activating mutations. In the SERENA-2 Phase II trial, camizestrant demonstrated PFS benefit versus Faslodex (fulvestrant) irrespective of ESR1 mutation status or prior treatment with CDK4/6 inhibitors in patients with ER-positive locally advanced or metastatic breast cancer, previously treated with endocrine therapy. The SERENA-1 Phase I trial demonstrated that camizestrant is well tolerated and has a promising anti-tumour profile when administered alone or in combination with palbociclib, ribociclib and abemaciclib; three widely used CDK4/6 inhibitors. Combinations with other agents are ongoing in SERENA-1. AstraZeneca in breast cancer Driven by a growing understanding of breast cancer biology, AstraZeneca is challenging, and redefining, the current clinical paradigm for how breast cancer is classified and treated to deliver even more effective treatments to patients in need – with the bold ambition to one day eliminate breast cancer as a cause of death. AstraZeneca has a comprehensive portfolio of approved and promising compounds in development that leverage different mechanisms of action to address the biologically diverse breast cancer tumour environment. With Enhertu (trastuzumab deruxtecan), a HER2-directed ADC, AstraZeneca and Daiichi Sankyo are aiming to improve outcomes in previously treated HER2-positive, HER2-low and HER2-ultralow metastatic breast cancer, and are exploring its potential in earlier lines of treatment and in new breast cancer settings. In HR-positive breast cancer, AstraZeneca continues to improve outcomes with foundational medicines Faslodex and Zoladex (goserelin) and aims to reshape the HR-positive space with first-in-class AKT inhibitor, Truqap (capivasertib), the TROP-2-directed ADC, Datroway (datopotamab deruxtecan) and next-generation oral SERD and potential new medicine camizestrant. PARP inhibitor Lynparza (olaparib) is a targeted treatment option that has been studied in early and metastatic breast cancer patients with an inherited BRCA mutation. AstraZeneca with MSD (Merck & Co., Inc. in the US and Canada) continue to research Lynparza in these settings and to explore its potential in earlier disease. AstraZeneca is also exploring the efficacy and safety of saruparib, a potent and selective inhibitor of PARP1, in combination with camizestrant in BRCA-mutated, HR-positive, HER2-negative advanced breast cancer. To bring much-needed treatment options to patients with triple-negative breast cancer, an aggressive form of breast cancer, AstraZeneca is collaborating with Daiichi Sankyo to evaluate the potential of Datroway alone and in combination with immunotherapy Imfinzi (durvalumab). AstraZeneca in oncology AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and deliver life-changing medicines to patients. The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience. AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death. AstraZeneca AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @ AstraZeneca . Contacts For details on how to contact the Investor Relations Team, please click here . For Media contacts, click here . References SOURCE: AstraZeneca