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
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
彪馬生物技術公司在2020年WCLC大會上公佈了neratinib治療EGFR外顯子18突變、轉移性非小細胞肺癌的第二階段峯會試驗的中期結果
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.
彪馬生物技術公司(納斯達克股票代碼：PBYI)，一家生物製藥公司，公佈了在轉移性非小細胞肺癌(NSCLC)患者中進行的neratinib高峯試驗的中期結果，這些患者帶有表皮生長因子(EGFR)外顯子18突變，這些患者以前曾接受過EGFR靶向酪氨酸激酶抑制劑(TKI)的治療。這些數據是在2020年世界肺癌大會(WCLC 2020)上的口頭討論中提出的，該會議由國際肺癌研究協會(IASLC)提交，目前正在新加坡舉行。這篇題為“預處理EGFR外顯子18突變的非小細胞肺癌(NSCLC)：頂峯籃子試驗的初步發現”的報告由瓦倫蒂娜·博尼醫學博士、START馬德里CIOCC公司、Centro Oncologico Clara CampAl公司、HM Sanchinarro公司在一次口頭會議上發表。
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.
第二階段頂峯籃子試驗是一項開放的、多中心的多國研究，目的是評估每日給予具有激活EGFR外顯子18或HER2突變的實體腫瘤患者的耐拉替尼的安全性和有效性。在EGFR外顯子18突變隊列中，具有單一或複雜EGFR外顯子18突變的肺癌患者，他們是EGFR TKI幼稚的或以前接觸過EGFR TKI，被納入這項研究，每天接受240毫克的neratinib作為單一藥物。
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).
在這個由11人組成的隊列中，患者在進入試驗之前接受了轉移性環境下(1-3個先前方案)的中位數2個先前的治療方案。10名患者以前曾接受過EGFR靶向酪氨酸激酶抑制劑(吉非替尼、厄洛替尼、奧西美替尼和/或阿法替尼)的治療(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.
試驗的中期療效結果顯示，在10名以前接受過EGFR酪氨酸激酶抑制劑治療的可評估患者中，6名患者(60%)出現部分反應，其中4名患者(40%)確認為部分反應。8名患者(80%)獲得臨牀益處(臨牀益處被定義為確認的完全緩解或部分緩解或病情穩定至少16周)。中位緩解期為7.5個月，中位無進展生存期為9.1個月。西蒙的兩階段設計的第一階段和第二階段的成功標準都得到了滿足，該隊列的第二階段的註冊仍在繼續。
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外顯子18突變的NSCLC患者亞組中觀察到的安全性情況顯示，在試驗中接受奈拉替尼治療的11名患者中，沒有3級或更高級別腹瀉的報告。4名患者(36%)報告1級腹瀉，1名患者(9%)報告2級腹瀉。沒有患者需要維持劑量、減少劑量、住院或因腹瀉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."
博尼博士是這項試驗的研究人員之一，他説：“我們對EGFR外顯子18突變肺癌的這些早期研究結果感到非常興奮，一旦他們未能通過FDA批准的EGFR TKI一線治療，對他們來説幾乎沒有有效的治療選擇。”
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."
加州大學洛杉磯分校血液與腫瘤學副教授、藥物開發副主任、胸科腫瘤學臨牀試驗主任喬納森·戈德曼醫學博士説：“這些早期研究結果為EGFR外顯子18突變陽性的非小細胞肺癌患者打開了一個潛在的有效選擇，一旦他們未能通過FDA批准的TKI一線治療。”
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."
彪馬生物技術公司首席執行官兼總裁艾倫·H·奧爾巴赫補充説：“我們很高興在世界肺癌大會上公佈這一數據，並提高肺癌社區內這些患者對neratinib活性的認識。我們正在繼續招募這批患者參加頂峯試驗，我們仍然相信，對於以前接受過EGFR靶向酪氨酸激酶抑制劑治療的EGFR外顯子18突變非小細胞肺癌患者，需要新的治療方法。”
About Puma Biotechnology
關於彪馬生物技術
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.
彪馬生物技術公司是一家生物製藥公司，專注於創新產品的開發和商業化，以加強癌症治療。彪馬In-授權PB272(口服奈拉替尼)、PB272(奈拉替尼靜脈注射)和PB357的全球開發和商業化權利。Neratinib口服於2017年獲得美國食品和藥物管理局(FDA)的批准，用於HER2過度表達/放大的早期乳腺癌成人患者的延長輔助治療，基於曲妥珠單抗的輔助治療，並在美國以NERLYNX®(Neratinib)片劑的形式銷售。2020年2月，NERLYNX還被FDA批准與卡培他濱聯合用於治療晚期或轉移性HER2陽性乳腺癌的成年患者，這些患者之前在轉移環境中接受了兩種或兩種以上基於HER2的抗化療方案。NERLYNX於2018年獲得歐盟委員會的營銷授權，可以延長對患有早期激素受體陽性HER2過度表達/放大的乳腺癌的成年患者的輔助治療，這些患者距離之前完成基於曲妥珠單抗的輔助治療不到一年。NERLYNX是彪馬生物技術公司的註冊商標。
Further information about Puma Biotechnology may be found at www.pumabiotechnology.com.
欲瞭解有關彪馬生物技術公司的更多信息，請訪問：Www.pumabiotechnology.com.
IMPORTANT SAFETY INFORMATION
重要安全信息
NERLYNX® (neratinib) tablets, for oral use
NERLYNX®(奈拉替尼)片劑，口服
INDICATIONS AND USAGE: NERLYNX is a kinase inhibitor indicated:
適應症和用法：NERLYNX是一種激酶抑制劑，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.
- 作為單一藥物，用於早期HER2陽性乳腺癌成人患者的擴大輔助治療，以曲妥珠單抗為基礎的輔助治療。
- 與卡培他濱聯合用於治療晚期或轉移性HER2陽性乳腺癌的成年患者，這些患者之前在轉移環境中接受過兩種或兩種以上基於抗HER2的治療方案。
CONTRAINDICATIONS: None
禁忌症：無
WARNINGS AND PRECAUTIONS:
警告和注意事項：
- 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.
- 腹瀉：積極控制腹瀉。如果在推薦的預防措施下仍出現腹瀉，請按照臨牀指示使用額外的止瀉藥、液體和電解質進行治療。在經歷嚴重和/或持續性腹瀉的患者中不要服用NERLYNX。在最大劑量減少後出現4級腹瀉或≥2級腹瀉的患者永久停止服用耐力寧。
- 肝毒性：在治療的前3個月每月監測肝功能檢查，然後在治療期間和臨牀顯示的情況下每3個月監測一次肝功能。在出現3級肝臟異常的患者中停用NERLYNX，在出現4級肝臟異常的患者中永久停用NERLYNX。
- 胚胎-胎兒毒性：NERLYNX會對胎兒造成傷害。建議患者注意胎兒的潛在風險，並使用有效的避孕措施。
ADVERSE REACTIONS:
不良反應：
The most common adverse reactions (reported in ≥ 5% of patients) were as follows:
最常見的不良反應(在≥中有5%的患者報告)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單藥：腹瀉、噁心、腹痛、疲勞、嘔吐、皮疹、口腔炎、食慾減退、肌肉痙攣、消化不良、AST或ALT升高、指甲紊亂、皮膚乾燥、腹脹、鼻出血、體重減輕和尿路感染。
- NERLYNX聯合卡培他濱治療：腹瀉、噁心、嘔吐、食慾減退、便祕、疲乏/乏力、體重減輕、頭暈、背痛、關節痛、尿路感染、上呼吸道感染、腹脹、腎功能損害和肌肉痙攣。
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.
要報告疑似不良反應，請聯繫彪馬生物技術公司，電話：1-844-NERLYNX(1-844-637-5969)或FDA，電話：1-800-FDA-1088，或Www.fda.gov/medwatch.
DRUG INTERACTIONS:
藥物相互作用：
- 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.
- 胃酸降解劑：避免與質子泵抑制劑同時使用。當病人需要胃酸減低劑時，使用H2受體拮抗劑或抗酸劑。用抗酸劑將NERLYNX分開至少3小時。在H2受體拮抗劑使用前至少2小時或使用後10小時將NERLYNX分開。
- 強力CYP3A4抑制劑：避免同時使用。
- 中度CYP3A4和P-糖蛋白(P-gp)雙重抑制劑：避免同時使用。
- 強或中度CYP3A4誘導劑：避免同時使用。
- P-糖蛋白(P-gp)底物：當與NERLYNX聯合使用時，監測作為P-gp底物的狹窄治療劑的不良反應。
USE IN SPECIFIC POPULATIONS:
在特定人羣中使用：
• Lactation: Advise women not to breastfeed.
• 哺乳期：建議女性不要母乳餵養。
Please see Full Prescribing Information for additional safety information.
請看完整的預錄信息瞭解更多安全信息。
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.
為了幫助確保患者能夠使用NERLYNX，彪馬實施了彪馬患者Lynx支持計劃，為患者和醫療保健提供者提供報銷支持，並轉介到可以幫助提供財政援助的資源。有關彪馬患者Lynx計劃的更多信息，請訪問：Www.NERLYNX.com或1-855-816-5421。
View source version on businesswire.com: https://www.businesswire.com/news/home/20210129005006/en/
在business wire.com上查看源代碼版本：Https://www.businesswire.com/news/home/20210129005006/en/
譯文內容由第三人軟體翻譯。