LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA-Lung1) Phase II trial (PUMA-ALI-4201; NCT06095505) of alisertib monotherapy for the treatment of patients with extensive stage small cell lung cancer.

洛杉矶--（商业新闻短讯）--生物制药公司Puma Biotechnology，Inc.（纳斯达克：PBYI）宣布启动其ALISertib in CAncer（ALISCA-Lung1）II期临床试验（Puma-ALI-4201；NCT06095505），用于治疗广泛期小细胞肺癌患者。

The ALISCA-Lung1 trial will enroll up to 60 patients with extensive stage small cell lung cancer who have progressed on or after first-line platinum-based chemotherapy and immunotherapy. Patients must provide tissue specimens so that biomarkers can be analyzed. Alisertib is dosed at 50 mg BID on days 1-7 of every 21-day cycle..

ALISCA-Lung1试验将招募多达60名在一线铂类化疗和免疫治疗后进展的广泛期小细胞肺癌患者。患者必须提供组织标本，以便可以分析生物标志物。Alisertib在每21天周期的第1-7天以50毫克的BID给药。。

The primary endpoint of the trial is objective response rate, with secondary endpoints of duration of response, disease control rate, progression-free survival and overall survival. Puma will also be looking at each of these endpoints within selected pre-specified biomarker subgroups and will assess whether there is enhanced efficacy in any biomarker subgroup.

该试验的主要终点是客观缓解率，次要终点是缓解持续时间，疾病控制率，无进展生存期和总生存期。Puma还将在选定的预先指定的生物标志物亚组中观察这些终点中的每一个，并将评估任何生物标志物亚组中是否有增强的功效。

Puma will be performing its biomarker analysis of the ALISCA-Lung1 trial in parallel with the execution of the clinical trial. Puma plans to perform an initial interim analysis for the evaluation of the biomarkers as well as an evaluation of efficacy. Based upon the outcomes of the study, Puma anticipates meeting with the U.S.

Puma将在执行临床试验的同时，对ALISCA-Lung1试验进行生物标志物分析。Puma计划对生物标志物的评估以及疗效评估进行初步的中期分析。根据研究结果，彪马预计将与美国会面。

Food and Drug Administration to explore the potential for an accelerated approval pathway for alisertib in small cell lung cancer..

美国食品和药物管理局（FDA）将探索在小细胞肺癌中加速阿利塞替尼批准途径的潜力。。

“Treatment options for patients with small cell lung cancer that has progressed on or after platinum-based chemotherapy are limited, and there is an urgent need for new drugs to treat this patient population,” said Taofeek K. Owonikoko, MD, PhD, Marlene and Stewart Greenbaum Professor of Oncology in the Department of Medicine at the University of Maryland, Baltimore.

巴尔的摩马里兰大学医学系肿瘤学教授Taofeek K.Owonikoko博士说：“铂类化疗前后进展的小细胞肺癌患者的治疗选择有限，迫切需要新药来治疗这一患者群体。”。

“The results from the previous clinical trials of alisertib in small cell lung cancer suggest that the drug may represent a potentially promising treatment option for these patients and, more specifically, for patient subsets whose tumors harbor potential molecular markers that are likely associated with the clinical activity of an aurora kinase A inhibitor such as alisertib,” said Dr.

“先前阿利替尼在小细胞肺癌中的临床试验结果表明，该药物可能代表了这些患者的潜在有希望的治疗选择，更具体地说，对于肿瘤具有潜在分子标志物的患者亚群，这些分子标志物可能与极光激酶a抑制剂（如阿利替尼）的临床活性有关，”博士说。

Owonikoko..

Owonikoko。

Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma, stated, “We are pleased to initiate this Phase II trial, and we hope that the study will provide much needed insight into the clinical activity of alisertib in small cell lung cancer and, more specifically, in patients with molecularly defined tumors that may be targetable with an aurora kinase A inhibitor like alisertib.”.

Puma首席执行官、总裁兼创始人艾伦·奥尔巴赫（AlanH.Auerbach）表示：“我们很高兴启动这项II期临床试验，我们希望这项研究能够为小细胞肺癌中alisertib的临床活性提供急需的见识，更具体地说，是对分子定义的肿瘤患者的见识，这些肿瘤可能会被类似alisertib的极光激酶A抑制剂靶向。”。

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-licensed the global development and commercialization rights to PB272 (neratinib, oral), PB272 (neratinib, intravenous) and PB357. Neratinib, oral was approved by the U.S.

Puma Biotechnology，Inc.是一家生物制药公司，专注于创新产品的开发和商业化，以增强癌症护理。Puma in向PB272（奈拉替尼，口服），PB272（奈拉替尼，静脉注射）和PB357授予了全球开发和商业化权利。口服奈拉替尼已获得美国批准。

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.

美国食品和药物管理局于2017年对早期HER2过表达/扩增乳腺癌的成年患者进行了扩展辅助治疗，随后进行了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，这些患者在转移性环境中接受了两种或更多种先前基于抗HER2的方案。

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于2018年获得欧盟委员会的上市授权，用于延长早期激素受体阳性HER2过表达/扩增乳腺癌的成年患者的辅助治疗，这些患者在完成之前的曲妥珠单抗辅助治疗后不到一年。

NERLYNX is a registered trademark of Puma Biotechnology, Inc..

NERLYNX是Puma Biotechnology，Inc.的注册商标。。

In September 2022, Puma entered into an exclusive license agreement for the development and commercialization of the anti-cancer drug alisertib, a selective, small molecule, orally administered inhibitor of aurora kinase A. Initially, Puma intends to focus the development of alisertib on the treatment of small cell lung cancer and breast cancer..

2022年9月，Puma签订了抗癌药物alisertib开发和商业化的独家许可协议，alisertib是一种选择性小分子口服极光激酶a抑制剂。最初，Puma打算将alisertib的开发重点放在治疗小细胞肺癌和乳腺癌上。。

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

有关Puma生物技术的更多信息，请访问https://www.pumabiotechnology.com.

Forward-Looking Statements

前瞻性声明

This press release contains forward-looking statements, including statements regarding Puma’s expectations regarding the development of alisertib and clinical trials involving alisertib. All forward-looking statements involve risks and uncertainties that could cause Puma’s actual results to differ materially from the anticipated results and expectations expressed in these forward-looking statements.

本新闻稿包含前瞻性声明，包括关于Puma对alisertib开发和涉及alisertib的临床试验的期望的声明。所有前瞻性陈述都涉及风险和不确定性，这些风险和不确定性可能导致Puma的实际结果与这些前瞻性陈述中表达的预期结果和期望存在重大差异。

These statements are based on current expectations, forecasts and assumptions, and actual outcomes and results could differ materially from these statements due to a number of factors, which include, but are not limited to, the risk factors disclosed in the periodic and current reports filed by Puma with the Securities and Exchange Commission from time to time, including Puma’s Annual Report on Form 10-K for the year ended December 31, 2022 and subsequent reports.

这些报表基于当前的预期、预测和假设，由于多种因素，实际结果和结果可能与这些报表存在重大差异，包括但不限于Puma不时向证券交易委员会提交的定期和当前报告中披露的风险因素，包括Puma截至2022年12月31日的10-K表年度报告和后续报告。

Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Puma assumes no obligation to update these forward-looking statements, except as required by law..

提醒读者不要过度依赖这些前瞻性声明，这些声明仅在本协议签署之日起生效。Puma没有义务更新这些前瞻性声明，除非法律要求。。