Taxane

今日（5月16日），中国国家药监局药品审评中心（CDE）官网最新公示，科伦博泰申报的注射用芦康沙妥珠单抗拟纳入优先审评，用于既往接受过内分泌治疗且在晚期或转移性阶段接受过其他系统治疗的不可切除的局部晚期或转移性激素受体阳性（HR+）且人表皮生长因子受体2阴性（HER2-）乳腺癌成人患者。芦康沙妥珠单抗是一款新型TROP2靶向抗体偶联药物（ADC），此前已经在中国获批两项适应症。截图来源：CDE官网公开资料显示，芦康沙妥珠单抗通过重组抗TROP2人源化单克隆抗体特异性识别肿瘤细胞表面的TROP2，其后被肿瘤细胞内吞并于细胞内释放KL610023。KL610023作为拓扑异构酶I抑制剂，可诱导肿瘤细胞DNA损伤，进而导致细胞周期阻滞及细胞凋亡。此外，其亦于肿瘤微环境中释放KL610023。鉴于KL610023具有细胞膜渗透性，其可实现旁观者效应，即杀死邻近的肿瘤细胞。2022年5月，科伦博泰授予默沙东（MSD）在大中华区以外的所有地区开发、使用、制造及商业化芦康沙妥珠单抗的独家权利。芦康沙妥珠单抗的2项适应症已于中国获批上市，分别用于治疗既往至少接受过2种系统治疗（其中至少1种治疗针对晚期或转移性阶段）的不可切除的局部晚期或转移性三阴性乳腺癌和经EGFR-TKI和含铂化疗治疗后进展的EGFR突变阳性的局部晚期或转移性非鳞状非小细胞肺癌。此外，该产品用于治疗经EGFR-TKI治疗后进展的EGFR突变局部晚期或转移性非小细胞肺癌的新药上市申请（NDA）已获NMPA受理，并被纳入优先审评。本次芦康沙妥珠单抗又一项新适应症被拟纳入优先审评，既往接受过内分泌治疗且在晚期或转移性阶段接受过其他系统治疗的不可切除的局部晚期或转移性HR+/HER2-乳腺癌成人患者。在2023年的ESMO大会上，研究人员公布了芦康沙妥珠单抗治疗经治的HR+/HER2-转移性乳腺癌（mBC）的1/2期临床研究结果。HR+/HER2- mBC患者以5mg/kg Q2W的剂量接受SKB264治疗，直到出现进展或不可接受的毒性。入选条件包括内分泌治疗进展和至少一次既往mBC化疗。根据研究者评估的RECIST v1.1每8周进行一次肿瘤评估。截至数据截止日期（2023年4月12日），纳入41例患者。中位随访时间为8.2个月。在38名可评估疗效的患者中，47%的患者有原发性内分泌抵抗；79%的患者既往因转移性疾病接受过≥2次化疗，既往治疗包括紫杉烷（100%）和CDK4/6抑制剂（65.8%）。客观缓解率（ORR）为36.8%（14/38,12例确定PR，2例未确定PR)， 疾病控制率（DCR）为89.5%，中位缓解持续时间（DOR）为7.4个月（范围，4.2~14.9+），6个月DoR率为80%。中位无进展生存期（PFS）为11.1个月， 6个月PFS率为61.2%。研究人员认为，5mg/kg的芦康沙妥珠单抗在经治的HR+/HER2- mBC患者中显示出可控的安全性和有希望的抗肿瘤活性。本次芦康沙妥珠单抗拟纳入优先审评，意味着该产品又一项适应症有望加速惠及患者。参考资料：[1]中国国家药监局药品审评中心（CDE）官网. Retrieved May 16，2025, From https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c[2]380MO - SKB264 (MK-2870) in previously treated hormone receptor-positive (HR+)/ HER2-negative metastatic breast cancer (mBC): Results from a phase I/II, single-arm, basket trial. Retrieved Oct 22，2023, From https://cslide.ctimeetingtech.com/esmo2023/attendee/confcal/presentation/list?q=380MO&c=pnr免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。

NATALEE subanalysis evaluates Kisqali in pre-menopausal early breast cancer patients, amid rising diagnosis rates in younger patients Pluvicto analysis and Scemblix ASC4START primary endpoint results provide insights into use in earlier settingsFabhalta APPULSE-PNH full results build on Phase III program, reporting new data from expanded PNH population in adults switching from anti-C5Ianalumab Phase II data in immune thrombocytopenia and longer-term pelabresib Phase III data in myelofibrosis show breadth of pipeline in hematologic diseases Basel, May 15, 2025 – Novartis will present data from 60 company or investigator sponsored abstracts that have the potential to change clinical practice, at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2025 Congress. “The breadth of our oncology and hematology portfolio – anchored by Kisqali, Pluvicto, Scemblix and Fabhalta – demonstrates our leadership in both solid tumors and hematologic diseases,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “At ASCO and EHA, we will present new data on these priority medicines as well as updates from our pipeline and our industry-leading radioligand therapy research.” Novartis will also highlight its US partnerships with the National Football League (NFL), Alliance for Breast Cancer Policy, and ZERO Prostate Cancer, which encourage people to make proactive decisions about their health and advance patient-centered policy solutions to help improve outcomes. “We're witnessing a profound shift in how people move through their cancer journey, with cancer diagnoses occurring at younger ages and, simultaneously, older patients living longer and approaching aging with new vigor,” said Victor Bultó, President, US, Novartis. “As a leader in driving medical advances in oncology, we have the responsibility to also make a difference in areas beyond treatment innovation. By partnering across the ecosystem, our goal is to advance the conversation around earlier detection and meet the evolving needs of this next generation of cancer patients.” Key highlights of data accepted by ASCO include: Medicine Abstract Title Abstract Number/ Presentation Details Kisqali®(ribociclib)* Efficacy and safety of ribociclib (RIB) + nonsteroidal aromatase inhibitor (NSAI) in NATALEE: Analysis across menopausal status and age Abstract #516Rapid OralJune 1, 8:00 – 9:30am CDT Kisqali®(ribociclib) Real-world (RW) analysis of characteristics and risk of recurrence (ROR) in Black patients (pts) with HR+/HER2− early breast cancer (EBC) eligible for NATALEE Abstract #527Poster PresentationJune 2, 9:00am – 12:00pm CDT Kisqali®(ribociclib) Adjuvant WIDER: A phase 3b trial of ribociclib (RIB) + endocrine therapy (ET) as adjuvant treatment (tx) in a close-to-clinical-practice patient (pt) population with HR+/HER2− early breast cancer (EBC) Abstract #TPS617Poster PresentationJune 2, 9:00am – 12:00pm CDT Kisqali®(ribociclib) First-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in clinically aggressive hormone receptor (HR)+/HER2− advanced breast cancer (ABC): A subgroup analysis of patients (pts) with or without liver metastases (mets) from RIGHT Choice Abstract #1069Poster PresentationJune 2, 9:00am – 12:00pm CDT Scemblix®(asciminib) Efficacy and safety of asciminib (ASC) in patients (pts) with chronic-phase chronic myeloid leukemia (CML-CP) after 1 tyrosine kinase inhibitor (TKI): Interim analysis (IA) of the phase 2 ASC2ESCALATE trial Abstract #6516Rapid OralMay 30, 1:00 – 2:30pm CDT Scemblix® (asciminib) Primary endpoint results of the phase 3b ASC4START trial of asciminib (ASC) vs nilotinib (NIL) in newly diagnosed chronic phase chronic myeloid leukemia (CML-CP): Time to treatment discontinuation due to adverse events (TTDAE) Abstract #6501Oral PresentationJune 2, 3:00 – 6:00pm CDT Pluvicto®(lutetium Lu 177 vipivotide tetraxetan) Clinical outcomes of prompt versus deferred 177Lu-PSMA-617 initiation for metastatic castration-resistant prostate cancer (mCRPC) based on prior androgen receptor pathway inhibitor (ARPI) and taxane chemotherapy exposure: a real-world PRostatE Cancer dISease observatION (PRECISION) data platform analysis Abstract #e17030Online Publication Pluvicto®(lutetium Lu 177 vipivotide tetraxetan) Real-world outcomes among patients with metastatic castration-resistant prostate cancer (mCRPC) receiving guideline-recommended therapies after treatment with 177Lu-PSMA-617: a real-world PRostatE Cancer dISease observatION (PRECISION) data platform analysis Abstract #e17035Online Publication Pluvicto®(lutetium Lu 177 vipivotide tetraxetan) PSMA-delay castration (DC): An open-label, multicenter, randomized phase 3 study of [177Lu]Lu-PSMA-617 versus observation in patients with metachronous PSMA-positive oligometastatic prostate cancer (OMPC) Abstract #TPS5127Poster PresentationJune 2, 9:00am – 12:00pm CDT Key highlights of data accepted by EHA include: Medicine Abstract Title Abstract Number/ Presentation Details Fabhalta®(iptacopan) APPULSE-PNH: Oral iptacopan monotherapy demonstrates clinically meaningful hemoglobin (Hb) increases in patients (pts) with paroxysmal nocturnal hemoglobinuria (PNH) and Hb ≥10 g/dL on anti-C5 therapy Abstract #S183Oral PresentationJune 13, 5:00 – 6:15pm CEST Fabhalta®(iptacopan) The 2-year safety and efficacy of iptacopan monotherapy in patients with paroxysmal nocturnal hemoglobinuria (PNH) from APPLY- and APPOINT-PNH studies who entered the roll-over extension program (REP) Abstract #PF660Poster PresentationJune 13, 6:30 – 7:30pm CEST Scemblix®(asciminib) Asciminib (ASC) shows superior tolerability vs nilotinib (NIL) in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP): Primary endpoint results of the phase (Ph) 3b ASC4START trial Abstract #S166Oral PresentationJune 13, 5:00 – 6:25pm CEST Scemblix®(asciminib) Improved patient-reported outcomes (PROs) with asciminib (ASC) vs investigator-selected tyrosine kinase inhibitors (IS-TKIs) in newly diagnosed chronic myeloid leukemia (CML): ASC4FIRST wk 48 analysis Abstract #PS1588Poster PresentationJune 14, 6:30 – 7:30pm CEST Scemblix®(asciminib) Interim analysis (IA) results from ASC2ESCALATE support asciminib (ASC) as a treatment (Tx) option in chronic-phase chronic myeloid leukemia (CML-CP) after 1 tyrosine kinase inhibitor (TKI) Abstract #PF595Poster PresentationJune 13, 6:30 – 7:30pm CEST Pelabresib(DAK539) Pelabresib in combination with ruxolitinib for janus kinase inhibitor-naive patients with myelofibrosis: 72-week follow-up with long-term efficacy outcomes of the phase III MANIFEST-2 study Abstract #S223Oral PresentationJune 12, 5:00 – 6:15pm CEST Ianalumab(VAY736) A Phase 2 Study of Ianalumab in patients with primary immune thrombocytopenia previously treated with at least two lines of therapy (VAYHIT3) Abstract #S312Oral PresentationJune 15, 11:00am – 12:15pm CEST Rapcabtagene autoleucel (YTB323) Rapcabtagene Autoleucel (YTB323) in patients with relapsed/refractory diffuse large B-cell lymphoma: A phase II trial clinical update Abstract #PF1152Poster PresentationJune 13, 6:30 – 7:30pm CEST Novartis in oncologyThe Novartis oncology strategy focuses on people living with cancer and those who care for them, from loved ones to clinical care teams, including their providers. For the past 30+ years, the aim has been to extend and improve lives by discovering differentiated, innovative and practice-changing medicines for patients. As Novartis reimagines medicine, it collaborates with a wide range of patient advocacy groups and supports education, early cancer screening and diagnosis, all while innovating at a rate that is unparalleled in the industry. With approximately 35 research and development projects across solid tumors, hematology and radioligand therapy (RLT), Novartis is committed to using technology, leading science and patient-centered research to deliver pioneering cancer care for all those in need. DisclaimerThis press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. 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In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise. About Novartis Novartis is an innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach nearly 300 million people worldwide. Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram. # # # *Kisqali was developed by Novartis under a research collaboration with Astex Pharmaceuticals. Novartis Media RelationsE-mail: media.relations@novartis.com Novartis Investor RelationsCentral investor relations line: +41 61 324 7944E-mail: investor.relations@novartis.com