Capecitabine

NERLYNX® (neratinib) has been approved as a single agent for the treatment of early-stage HER2+ breast cancer, and in combination with capecitabine for the treatment of advanced or metastatic HER2+ breast cancer[1] Approval coincides with the first appointment of field force employees, signifying the growth of Specialised Therapeutics in Thailand SINGAPORE, Feb. 11, 2025 /PRNewswire/ -- A NEW breast cancer therapy shown to significantly reduce the risk of cancer recurrence and improve disease-free survival in women is now approved for use in Thailand.[1,2,3] NERLYNX® (neratinib), an oral medication, has been approved by the Thailand Food and Drug Administration (Thailand FDA) as a single agent "for the extended adjuvant treatment of adult patients with early-stage hormone receptor positive HER2-overexpressed/amplified breast cancer and who completed adjuvant trastuzumab-based therapy less than one year ago."[1] Additionally, NERLYNX has been approved in combination with capecitabine"for the treatment of adult patients with advanced or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2 based regimens in the metastatic setting."[1] In early breast cancer, NERLYNX has been shown to significantly reduce the ongoing risk of recurrence in women positive for human epidermal growth factor receptor 2 (HER2+), with the greatest benefit seen in women who are also hormone-receptor positive (HR+) and who commence therapy within 12 months of completing trastuzumab-based therapy.[2,3] For these women, the five-year risk of recurrence is reduced by up to 42%.[4] In women with advanced or metastatic HER2+ breast cancer, NERLYNX in combination with capecitabine (N+C) was found to significantly improve mean progression free survival (PFS) by 2.2 months over treatment with lapatinib plus capecitabine (L+C).[5] The duration of treatment response was longer for patients administered N+C (8.5 months) versus L+C (5.6 months), while the risk of disease progression or death was reduced by up to 24% among those treated with N+C at a median follow-up of 30 months.[5,6] NERLYNX is being made available in Thailand by independent pharmaceutical company, Specialised Therapeutics (ST), under exclusive license from Puma Biotechnology, Inc. ST Chief Executive Officer, Mr Carlo Montagner, said the approval of NERLYNX in Thailand was an important milestone for the company. "We are proud to have obtained approval of NERLYNX in Thailand for adults with HER2 positive breast cancer. This is a significant milestone for Specialised Therapeutics, but importantly also for women diagnosed with breast cancer in Thailand who will be presented with an opportunity to access a treatment that will help reduce the risk of disease recurrence and improve outcomes, in either the early or advanced stages of their disease." Breast cancer is the most common cancer diagnosed in Thai women, and the second leading cause of cancer mortality in females, behind liver cancer.[7] The incidence of breast cancer in Thailand has been rising at an alarming rate, with the annual age-standardised incidence rate doubling over the past 20 years (from 17.8/100,000 in 1998, to 35.7/100,000 in 2020).[8,9] In 2022, 21,628 Thai women were newly diagnosed with breast cancer, accounting for almost a quarter (23.2%) of all new cancer diagnoses in females.[7] Coinciding with the NERLYNX approval, ST is also pleased to announce the growth of its Thailand office, with new field force members due to join the company in March 2025. "We are extremely excited about the new journey we are undertaking in Thailand," said Mr Montagner. "Hiring our first field force employees, who have an extensive understanding of the local healthcare landscape, enables us to connect with oncologists around the country at the earliest opportunity, ahead of launching NERLYNX and making it available for eligible breast cancer patients as soon as possible. "As we continue to seek approvals for our strong pipeline of specialised medicines and technologies, we remain committed to meeting the needs of patients with rare diseases across Thailand, and making a difference to their lives. We look forward to working with the Thailand FDA and local specialists as we endeavour to provide timely access to these new treatments for the patients that need them." Ends. About NERLYNX NERLYNX (neratinib) is an irreversible tyrosine kinase inhibitor (TKI) that blocks signal transduction through the epidermal growth factor receptors, HER1, HER2 and HER4.[10] It is an oral tablet and works by binding to multiple receptors inside the cancer cell, blocking signals that tell cancer cells to grow and multiply.[11,12] NERLYNX has received approval for the treatment of certain patients with extended adjuvant and/or metastatic HER2-positive breast cancer in more than 40 countries outside the United States (US), including the European Union (EU), China, Latin America, Australia, Canada, and Hong Kong. About HER2-Positive (HER2+) Breast Cancer Approximately 20-25% of breast cancer tumours over-express the HER2 protein. HER2-positive (HER2+) breast cancer is a highly heterogeneous tumour that is often more aggressive than other types of breast cancer and has a poor prognosis, increasing the risk of disease progression and death.[10,13,14] While trastuzumab has helped to improve the survival and prognosis of patients with HER2+ breast cancer, around 20-30% of patients will experience recurrence and metastases after trastuzumab targeted therapy.[14] About the ExteNET Study[2-4,15] The ExteNET trial was a double-blind, placebo-controlled, Phase III trial of neratinib versus placebo after adjuvant treatment with trastuzumab (Herceptin) in patients with early-stage HER2-positive breast cancer. The ExteNET trial randomised 2,840 patients in 41 countries with early-stage HER2-positive breast cancer who had undergone surgery and adjuvant treatment with trastuzumab. After completion of adjuvant treatment with trastuzumab, patients were randomised to receive neratinib or placebo for a period of one year. Patients were then followed for recurrent disease, ductal carcinoma in situ (DCIS), or death for a period of five years after randomisation. The primary endpoint of the trial was invasive disease-free survival (iDFS). The trial demonstrated that after a median follow up of 5.2 years, treatment with neratinib resulted in a 27% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.73, p = 0.008). The 5-year iDFS rate for the neratinib arm was 90.2%, versus 87.7% for the placebo arm. An additional five-year sub-group analysis demonstrated a 42% reduction in risk of recurrence and 59% reduction in risk of CNS recurrence or death of any cause in women who were HR+ and who had commenced neratinib therapy within 12 months of completing treatment with trastuzumab. The most common adverse reactions (≥ 5%) were diarrhoea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increase, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased and urinary tract infection. About the NALA Study[5,6] The NALA trial was a randomised, active-controlled, Phase III trial investigating the efficacy of neratinib, an irreversible pan-HER tyrosine kinase inhibitor (TKI), plus capecitabine (N+C) against lapatinib, a reversible dual TKI, plus capecitabine (L+C) in patients with centrally confirmed HER2+ metastatic breast cancer who had received two or more prior anti-HER2 based regimens in the metastatic setting. 621 patients were enrolled at 203 sites in 28 countries across Europe, North and South America, Asia, and Australia. The primary outcome measures for the trial were progression-free survival (PFS), and overall survival (OS). Median PFS was 5.6 months for patients who received N+C and 5.5 months for those receiving L+C (hazard ratio = 0.76, p = 0.0059). The PFS rate at 12 months was 29% versus 15%, respectively. Median OS was 21 months for patients receiving N+C, compared to 18.7 months for those receiving L+C (hazard ratio = 0.88, p = 0.2086). The most common adverse reactions of any grade (>5%) in the N+C arm were diarrhoea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, decreased weight, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms. About Specialised Therapeutics Founded in 2007, Specialised Therapeutics is the region's largest independent specialty pharmaceutical company, providing new therapies and technologies to patients in Australia, New Zealand and across Southeast Asia. Headquartered in Singapore, ST partners with global pharmaceutical, biotech and diagnostic companies to bring novel healthcare opportunities to patients who are impacted by a range of diseases. ST has built a strong track record of success, navigating complex regulatory, reimbursement and commercialisation environments in its diverse regions. The ST mission is to provide specialty therapies where there is an unmet need. The company's broad therapeutic portfolio currently includes novel agents in oncology, haematology, CNS, neurology, endocrinology, ophthalmology and supportive care, although it is not confined to these areas. ST is a member of the World Orphan Drug Alliance (WODA). Additional information can be found at . References: SOURCE Specialised Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

编者按：2025年1月23日至25日，美国临床肿瘤学会胃肠肿瘤研讨会（ASCO GI）在美国旧金山举行，汇聚了全球消化道肿瘤最新进展。对于胃癌系统治疗而言，紫杉醇是最重要的化疗药物之一。传统紫杉醇注射液往往因其不良反应而饱受诟病，我国研究者持续对紫杉醇的结构及剂型不断优化，以期追求更好的疗效和安全性，并成功开发上市了全球首款紫杉醇口服溶液，为患者带来了更便捷的治疗选择。本次会议中，上海高博肿瘤医院李进教授与南京天印山医院秦叔逵教授共同领衔的紫杉醇口服溶液对比紫杉醇注射液二线治疗晚期胃癌的Ⅲ期临床研究结果闪耀发布，以更好的治疗效果和良好的安全性为全球患者带来了更便利的选择。 01 《肿瘤瞭望》：请您谈谈紫杉醇在胃癌治疗中的地位？ 李进教授：紫杉醇仍然是胃癌治疗中最重要的化疗药物之一。胃癌的化疗药物包括顺铂、奥沙利铂、紫杉类和氟尿嘧啶类。其中，氟尿嘧啶类药物包括卡培他滨、替吉奥等；紫杉类包括多西紫杉醇、普通紫杉醇以及白蛋白紫杉醇。目前紫杉醇联合氟尿嘧啶或者铂类联合氟尿嘧啶均为胃癌的一线治疗标准方案。 在中国，胃癌一线治疗通常采用奥沙利铂联合氟尿嘧啶方案， 是因为奥沙利铂的主要不良反应为具有蓄积性的外周神经毒性。该药的外周神经毒性在前几个疗程中毒性较低，患者耐受较好。因此相较于紫杉类药物，奥沙利铂在患者耐受性方面显然有更大优势。临床医生多倾向于让患者使用低毒可耐受的药物，以维持更长的治疗周期，从而更好地保护病人。 当铂类联合氟尿嘧啶治疗失败后，我们往往将多西紫杉醇或者紫杉醇作为二线治疗标准方案。相较于紫杉醇注射液，白蛋白紫杉醇效果不差，且过敏反应等急性毒副反应发生率明显降低，因此临床医生更倾向使用白蛋白紫杉醇，其在二线治疗中仍占有一席之地。此外，我们还可以选择雷莫西尤单抗联合方案进行二线治疗，尽管其在总生存期（OS）上的延长方面不尽人意，但是在无进展生存期（PFS）方面仍然具有优势。目前，雷莫西尤单抗目前还未纳入医保报销范围，因此，对于经济条件较好的患者可以考虑该方案；对于经济能力较弱患者，则可选择紫杉醇、白蛋白紫杉醇或者多西紫杉醇等药物。 02 《肿瘤瞭望》：此次ASCO GI大会上，您团队的一项紫杉醇口服溶液相关研究得以公布，请您介绍一下该研究的设计及结果。 李进教授：如前所述，紫杉醇、白蛋白紫杉醇、多西紫杉醇等都是胃癌二线治疗的标准化疗方案。由于此类药物均为静脉注射给药，往往需要安装化疗泵、外周静脉置管或输液港，于患者而言，相当于一种创伤性的治疗。在此背景下，我们希望能为患者提供一种方便在家中使用的治疗药物。因此，我们开展了一项标准紫杉醇注射液与紫杉醇口服溶液头对头对照用于晚期胃癌二线治疗的临床研究。 在研究最初，我们仅想将紫杉醇口服溶液作为静脉紫杉醇注射液非劣效的替代方案，对延长PSF也抱有一丝期待。因为紫杉醇口服溶液可以通过减量或停药的方式降低毒副作用，这与静脉紫杉醇注射液一次性注入人体是完全不同的。若静脉紫杉醇注射液出现不良反应，患者只有在承受住化疗毒性后，在下次化疗时才能通过减少剂量以减轻毒性；而紫杉醇口服溶液则可以随时减量或停药，从而为改善患者生活质量提供了患者自行操作的方法，及时控制住了不良反应，提升了患者依从性。患者的耐受性好了，PFS则有更大希望得到延长。 最终，本研究显示紫杉醇口服溶液较静脉紫杉醇注射液不仅在数值上改善了mPFS（3.02个月vs 2.89个月，HR 0.894，95% CI：0.719-1.112，P=0.311）； 也显著改善了mOS（9.13个月vs 6.54个月，HR=0.770,95.5% CI：0.635-0.934，P=0.006）； 同时降低了降低毒副反应，使患者耐受性更好，生存期更长。 因此我认为，紫杉醇口服溶液未来将成为中国胃癌的标准二线治疗方案。通过这项研究，我们可以看到，即使已经进入了靶向治疗时代或者免疫治疗时代，对于传统化疗药物的改良仍然可行，仍然可以为患者带来更长的生存和更好的生活质量。 03 《肿瘤瞭望》：请问紫杉醇口服溶液的优势机制是怎样的？ 李进教授：口服紫杉醇的机制是通过使用油乳的方式将其溶解在口服溶液中，在患者口服后可以通过消化道吸收。紫杉醇口服溶液只有在吸收到体内后才能产生抗肿瘤的效果，对患者的消化道毒性轻微，仅较静脉紫杉醇注射液略微提高，大多数患者均能耐受。紫杉醇口服溶液的半衰期更长，即可在体内血液中循环停留更长时间。作为细胞周期特异性药物，在维持一定有效浓度时，随着暴露的时间的延长，就能阻断更多的肿瘤细胞进入细胞增殖周期，进而发挥强效的抑制肿瘤作用。以上便是紫杉醇口服溶液能够给患者带来更多获益的基本原理。 04 《肿瘤瞭望》：您对未来紫杉醇口服溶液的临床应用有哪些展望？ 李进教授：我国国家药品监督管理局已经批准了紫杉醇口服溶液上市。我相信在不久的未来，紫杉醇口服溶液将实现临床可及。曾经对于无法反复到医院就诊打针的患者，在某些情况下我们会采用每周注射一次紫杉醇的方式予以治疗。如今若采用紫杉醇口服溶液的方法，患者即可以在家中正常完成每周期的化疗，无需反复返院，从而减轻患者的奔波成本。另外，胃癌患者体质较差，没有足够的精力往返医院，紫杉醇口服溶液为患者减少了体力损耗，带来了更多便利。我相信，未来国家医保局会批准紫杉醇口服溶液进入医保，我们也期待那一天的早日到来，从而为广大肿瘤患者带来更便利、更经济、更有效、更安全的治疗方案。 ▌参考文献： Xinyu Bi, Xiao Liang, Guang Tan, Haitao Zhao, Tao Huang, Ming Zhao, Jinzhang Chen, Xiao-Dong Zhu, Jianfeng Xue, Hui-Chuan Sun, Jianqiang Cai. Current status of physicians’ perception of HCC conversion/downstaging therapy: A nationwide survey in China. 2025 ASCO GI Abs 585, Poster Bd C11. 李进 教授 中国药科大学附属上海高博肿瘤医院院长 同济大学附属上海东方医院终身教授 亚洲肿瘤联盟（FACO）主席 CSCO副监事长 CSCO基金会理事长 中国药促会肿瘤临床研究专委会主任委员 国家卫健委能建与继教肿瘤专家委员会副主任委员 中国临床肿瘤学会（CSCO）前理事长 中国临床肿瘤学会胃癌专家委员会主任委员 中国临床肿瘤学会大肠癌专委会候任主任委员 Cancer Science副主编 （来源：《肿瘤瞭望》编辑部） 声 明 凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息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，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。