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Puma Biotechnology Presents Interim Results From Phase II SUMMIT Trial Of Neratinib For EGFR Exon 18-Mutated, Metastatic Non-Small Cell Lung Cancer At WCLC 2020

Puma Biotechnology Presents Interim Results From Phase II SUMMIT Trial Of Neratinib For EGFR Exon 18-Mutated, Metastatic Non-Small Cell Lung Cancer At WCLC 2020

彪马生物技术公司在2020年WCLC大会上公布奈拉替尼治疗EGFR外显子18突变、转移性非小细胞肺癌第二阶段峰会的中期结果
Benzinga Real-time News ·  2021/01/29 21:09

Puma Biotechnology Presents Interim Results from the Phase II SUMMIT Trial of Neratinib for EGFR Exon 18-Mutated, Metastatic Non-Small Cell Lung Cancer at WCLC 2020

彪马生物技术公司在2020年WCLC大会上公布了neratinib治疗EGFR外显子18突变、转移性非小细胞肺癌的第二阶段峰会试验的中期结果

Puma Biotechnology, Inc. (NASDAQ:PBYI), a biopharmaceutical company, presented interim results from the ongoing SUMMIT trial of neratinib in the cohort of metastatic non-small cell lung cancer (NSCLC) patients with epidermal growth factor (EGFR) exon 18 mutations who have been previously treated with an EGFR targeted tyrosine kinase inhibitor (TKI). The data were presented in an oral discussion at the 2020 World Conference on Lung Cancer (WCLC 2020) presented by the International Association for the Study of Lung Cancer (IASLC) that is currently taking place in Singapore. The presentation, entitled, "Neratinib in Pretreated EGFR Exon 18-Mutated Non-Small Cell Lung Cancer (NSCLC): Initial Findings from the SUMMIT Basket Trial," is being presented at an Oral Session by Valentina Boni, MD, PhD, START Madrid-CIOCC, Centro Oncologico Clara Campal, HM Sanchinarro.

彪马生物技术公司(纳斯达克股票代码:PBYI),一家生物制药公司,公布了在转移性非小细胞肺癌(NSCLC)患者中进行的neratinib高峰试验的中期结果,这些患者带有表皮生长因子(EGFR)外显子18突变,这些患者以前曾接受过EGFR靶向酪氨酸激酶抑制剂(TKI)的治疗。这些数据是在2020年世界肺癌大会(WCLC 2020)上的口头讨论中提出的,该会议由国际肺癌研究协会(IASLC)提交,目前正在新加坡举行。这篇题为“预处理EGFR外显子18突变的非小细胞肺癌(NSCLC):顶峰篮子试验的初步发现”的报告由瓦伦蒂娜·博尼医学博士、START马德里CIOCC公司、Centro Oncologico Clara CampAl公司、HM Sanchinarro公司在一次口头会议上发表。

The Phase II SUMMIT basket trial is an open-label, multicenter, multinational study to evaluate the safety and efficacy of neratinib administered daily to patients who have solid tumors with activating EGFR exon 18 or HER2 mutations. In the EGFR exon 18 mutation cohort, patients with lung cancer with single or complex EGFR exon 18 mutations, who were EGFR TKI naïve or were previously exposed to EGFR TKI, were enrolled into this study and received 240 mg of neratinib daily as a single agent.

第二阶段顶峰篮子试验是一项开放的、多中心的多国研究,目的是评估每日给予具有激活EGFR外显子18或HER2突变的实体肿瘤患者的耐拉替尼的安全性和有效性。在EGFR外显子18突变队列中,具有单一或复杂EGFR外显子18突变的肺癌患者,他们是EGFR TKI幼稚的或以前接触过EGFR TKI,被纳入这项研究,每天接受240毫克的neratinib作为单一药物。

In this cohort of 11, patients had received a median of 2 prior lines of therapy in the metastatic setting (range 1-3 prior regimens) before entering the trial. 10 patients had been previously treated with an EGFR targeted tyrosine kinase inhibitor (gefitinib, erlotinib, osimertinib and/or afatinib).

在这个由11人组成的队列中,患者在进入试验之前接受了转移性环境下(1-3个先前方案)的中位数2个先前的治疗方案。10名患者以前曾接受过EGFR靶向酪氨酸激酶抑制剂(吉非替尼、厄洛替尼、奥西美替尼和/或阿法替尼)的治疗(gefitinib、erlotinib、osimertinib和/或afatinib)。

The interim efficacy results from the trial showed that for the 10 evaluable patients who had previously been treated with an EGFR tyrosine kinase inhibitor, 6 patients (60%) experienced a partial response, which included 4 patients (40%) with a confirmed partial response. 8 patients (80%) experienced clinical benefit (clinical benefit is defined as confirmed complete response or partial response or stable disease for at least 16 weeks). The median duration of response was 7.5 months and the median progression-free survival was 9.1 months. The success criteria for both the 1st stage and the 2nd stage of the Simon's 2-stage design were met and enrollment in the 2nd stage of this cohort continues.

试验的中期疗效结果显示,在10名以前接受过EGFR酪氨酸激酶抑制剂治疗的可评估患者中,6名患者(60%)出现部分反应,其中4名患者(40%)确认为部分反应。8名患者(80%)获得临床益处(临床益处被定义为确认的完全缓解或部分缓解或病情稳定至少16周)。中位缓解期为7.5个月,中位无进展生存期为9.1个月。西蒙的两阶段设计的第一阶段和第二阶段的成功标准都得到了满足,该队列的第二阶段的注册仍在继续。

The safety profile observed in the subgroup of patients with EGFR exon 18-mutated NSCLC showed that for the 11 patients who received neratinib in the trial, there were no reports of grade 3 or higher diarrhea. 4 patients (36%) reported grade 1 and 1 patient (9%) reported grade 2 diarrhea. No patients required a dose hold, dose reduction, hospitalization or permanently discontinued neratinib due to diarrhea.

在EGFR外显子18突变的NSCLC患者亚组中观察到的安全性情况显示,在试验中接受奈拉替尼治疗的11名患者中,没有3级或更高级别腹泻的报告。4名患者(36%)报告1级腹泻,1名患者(9%)报告2级腹泻。没有患者需要维持剂量、减少剂量、住院或因腹泻而永久停用奈拉替尼。

Dr. Boni, an investigator of the trial, said, "We are very excited about these early study results in EGFR exon 18 mutant lung cancer, for whom very few effective treatment options are available once they fail first-line FDA approved EGFR TKI therapy."

博尼博士是这项试验的研究人员之一,他说:“我们对EGFR外显子18突变肺癌的这些早期研究结果感到非常兴奋,一旦他们未能通过FDA批准的EGFR TKI一线治疗,对他们来说几乎没有有效的治疗选择。”

Jonathan Goldman, MD, Associate Professor of Hematology & Oncology, Associate Director of Drug Development, and Director of Clinical Trials in Thoracic Oncology at UCLA, said, "These early study results open up a potentially effective option for EGFR exon 18 mutation-positive NSCLC patients once they fail first-line FDA approved TKI therapy."

加州大学洛杉矶分校血液与肿瘤学副教授、药物开发副主任、胸科肿瘤学临床试验主任乔纳森·戈德曼医学博士说:“这些早期研究结果为EGFR外显子18突变阳性的非小细胞肺癌患者打开了一个潜在的有效选择,一旦他们未能通过FDA批准的TKI一线治疗。”

Alan H. Auerbach, CEO and President of Puma Biotechnology, added, "We are pleased to present this data at the World Conference on Lung Cancer and increase the awareness of neratinib's activity in this patient population within the lung cancer community. We are continuing to enroll this cohort of patients in the SUMMIT trial and we continue to believe that there is a need for new treatments for patients with EGFR exon 18-mutated NSCLC who have previously been treated with EGFR targeted tyrosine kinase inhibitors."

彪马生物技术公司首席执行官兼总裁艾伦·H·奥尔巴赫补充说:“我们很高兴在世界肺癌大会上公布这一数据,并提高肺癌社区内这些患者对neratinib活性的认识。我们正在继续招募这批患者参加顶峰试验,我们仍然相信,对于以前接受过EGFR靶向酪氨酸激酶抑制剂治疗的EGFR外显子18突变非小细胞肺癌患者,需要新的治疗方法。”

About Puma Biotechnology

关于彪马生物技术

Puma Biotechnology, Inc. is a biopharmaceutical company with a focus on the development and commercialization of innovative products to enhance cancer care. Puma in-licenses the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S. Food and Drug Administration in 2017 for the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, following adjuvant trastuzumab-based therapy, and is marketed in the United States as NERLYNX® (neratinib) tablets. In February 2020, NERLYNX was also approved by the FDA 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. NERLYNX was granted marketing authorization by the European Commission in 2018 for the extended adjuvant treatment of adult patients with early stage hormone receptor-positive HER2-overexpressed/amplified breast cancer and who are less than one year from completion of prior adjuvant trastuzumab-based therapy. NERLYNX is a registered trademark of Puma Biotechnology, Inc.

彪马生物技术公司是一家生物制药公司,专注于创新产品的开发和商业化,以加强癌症治疗。彪马In-授权PB272(口服奈拉替尼)、PB272(奈拉替尼静脉注射)和PB357的全球开发和商业化权利。Neratinib口服于2017年获得美国食品和药物管理局(FDA)的批准,用于HER2过度表达/放大的早期乳腺癌成人患者的延长辅助治疗,基于曲妥珠单抗的辅助治疗,并在美国以NERLYNX®(Neratinib)片剂的形式销售。2020年2月,NERLYNX还被FDA批准与卡培他滨联合用于治疗晚期或转移性HER2阳性乳腺癌的成年患者,这些患者之前在转移环境中接受了两种或两种以上基于HER2的抗化疗方案。NERLYNX于2018年获得欧盟委员会的营销授权,可以延长对患有早期激素受体阳性HER2过度表达/放大的乳腺癌的成年患者的辅助治疗,这些患者距离之前完成基于曲妥珠单抗的辅助治疗不到一年。NERLYNX是彪马生物技术公司的注册商标。

Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.

欲了解有关彪马生物技术公司的更多信息,请访问:Www.pumabiotechnology.com.

IMPORTANT SAFETY INFORMATION

重要安全信息

NERLYNX® (neratinib) tablets, for oral use

NERLYNX®(奈拉替尼)片剂,口服

INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:

适应症和用法:NERLYNX是一种激酶抑制剂,表明:

  • As a single agent, for the extended adjuvant treatment of adult patients with early-stage HER2-positive breast cancer, to follow adjuvant trastuzumab-based therapy.
  • 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.
  • 作为单一药物,用于早期HER2阳性乳腺癌成人患者的扩大辅助治疗,以曲妥珠单抗为基础的辅助治疗。
  • 与卡培他滨联合用于治疗晚期或转移性HER2阳性乳腺癌的成年患者,这些患者之前在转移环境中接受过两种或两种以上基于抗HER2的治疗方案。

CONTRAINDICATIONS: None

禁忌症:

WARNINGS AND PRECAUTIONS:

警告和注意事项:

  • Diarrhea: Aggressively manage diarrhea. If diarrhea occurs despite recommended prophylaxis, treat with additional antidiarrheals, fluids, and electrolytes as clinically indicated. Withhold NERLYNX in patients experiencing severe and/or persistent diarrhea. Permanently discontinue NERLYNX in patients experiencing Grade 4 diarrhea or Grade ≥ 2 diarrhea that occurs after maximal dose reduction.
  • Hepatotoxicity: Monitor liver function tests monthly for the first 3 months of treatment, then every 3 months while on treatment and as clinically indicated. Withhold NERLYNX in patients experiencing Grade 3 liver abnormalities and permanently discontinue NERLYNX in patients experiencing Grade 4 liver abnormalities.
  • Embryo-Fetal Toxicity: NERLYNX can cause fetal harm. Advise patients of potential risk to a fetus and to use effective contraception.
  • 腹泻:积极控制腹泻。如果在推荐的预防措施下仍出现腹泻,请按照临床指示使用额外的止泻药、液体和电解质进行治疗。在经历严重和/或持续性腹泻的患者中不要服用NERLYNX。在最大剂量减少后出现4级腹泻或≥2级腹泻的患者永久停止服用耐力宁。
  • 肝毒性:在治疗的前3个月每月监测肝功能检查,然后在治疗期间和临床显示的情况下每3个月监测一次肝功能。在出现3级肝脏异常的患者中停用NERLYNX,在出现4级肝脏异常的患者中永久停用NERLYNX。
  • 胚胎-胎儿毒性:NERLYNX会对胎儿造成伤害。建议患者注意胎儿的潜在风险,并使用有效的避孕措施。

ADVERSE REACTIONS:

不良反应:

The most common adverse reactions (reported in ≥ 5% of patients) were as follows:

最常见的不良反应(在≥中有5%的患者报告)如下:

  • NERLYNX as a single agent: Diarrhea, nausea, abdominal pain, fatigue, vomiting, rash, stomatitis, decreased appetite, muscle spasms, dyspepsia, AST or ALT increased, nail disorder, dry skin, abdominal distention, epistaxis, weight decreased, and urinary tract infection.
  • NERLYNX in combination with capecitabine: Diarrhea, nausea, vomiting, decreased appetite, constipation, fatigue/asthenia, weight decreased, dizziness, back pain, arthralgia, urinary tract infection, upper respiratory tract infection, abdominal distention, renal impairment, and muscle spasms.
  • NERLYNX单药:腹泻、恶心、腹痛、疲劳、呕吐、皮疹、口腔炎、食欲减退、肌肉痉挛、消化不良、AST或ALT升高、指甲紊乱、皮肤干燥、腹胀、鼻出血、体重减轻和尿路感染。
  • NERLYNX联合卡培他滨治疗:腹泻、恶心、呕吐、食欲减退、便秘、疲乏/乏力、体重减轻、头晕、背痛、关节痛、尿路感染、上呼吸道感染、腹胀、肾功能损害和肌肉痉挛。

To report SUSPECTED ADVERSE REACTIONS, contact Puma Biotechnology, Inc. at 1-844-NERLYNX (1-844-637-5969) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

要报告疑似不良反应,请联系彪马生物技术公司,电话:1-844-NERLYNX(1-844-637-5969)或FDA,电话:1-800-FDA-1088,或Www.fda.gov/medwatch.

DRUG INTERACTIONS:

药物相互作用:

  • Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors. When patients require gastric acid reducing agents, use an H2-receptor antagonist or antacid. Separate NERLYNX by at least 3 hours with antacids. Separate NERLYNX by at least 2 hours before or 10 hours after H2-receptor antagonists.
  • Strong CYP3A4 inhibitors: Avoid concomitant use.
  • Moderate CYP3A4 and P-glycoprotein (P-gp) dual inhibitors: Avoid concomitant use.
  • Strong or moderate CYP3A4 inducers: Avoid concomitant use.
  • P-glycoprotein (P-gp) substrates: Monitor for adverse reactions of narrow therapeutic agents that are P-gp substrates when used concomitantly with NERLYNX.
  • 胃酸降解剂:避免与质子泵抑制剂同时使用。当病人需要胃酸减低剂时,使用H2受体拮抗剂或抗酸剂。用抗酸剂将NERLYNX分开至少3小时。在H2受体拮抗剂使用前至少2小时或使用后10小时将NERLYNX分开。
  • 强力CYP3A4抑制剂:避免同时使用。
  • 中度CYP3A4和P-糖蛋白(P-gp)双重抑制剂:避免同时使用。
  • 强或中度CYP3A4诱导剂:避免同时使用。
  • P-糖蛋白(P-gp)底物:当与NERLYNX联合使用时,监测作为P-gp底物的狭窄治疗剂的不良反应。

USE IN SPECIFIC POPULATIONS:

在特定人群中使用:

• Lactation: Advise women not to breastfeed.

哺乳期:建议女性不要母乳喂养。

Please see Full Prescribing Information for additional safety information.

请看完整的预录信息了解更多安全信息。

To help ensure patients have access to NERLYNX, Puma has implemented the Puma Patient Lynx support program to assist patients and healthcare providers with reimbursement support and referrals to resources that can help with financial assistance. More information on the Puma Patient Lynx program can be found at www.NERLYNX.com or 1-855-816-5421.

为了帮助确保患者能够使用NERLYNX,彪马实施了彪马患者Lynx支持计划,为患者和医疗保健提供者提供报销支持,并转介到可以帮助提供财政援助的资源。有关彪马患者Lynx计划的更多信息,请访问:Www.NERLYNX.com或1-855-816-5421。

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译文内容由第三方软件翻译。


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