LOS ANGELES--(BUSINESS WIRE)--Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced the initiation of its ALISertib in CAncer (ALISCA™-Breast1) Phase II trial (PUMA-ALI-1201; NCT06369285) of alisertib in combination with endocrine therapy for the treatment of patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-negative) recurrent or metastatic breast cancer who have been previously treated with CDK 4/6 inhibitors and received at least two prior lines of endocrine therapy in the recurrent or metastatic setting.

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™-Breast1）II期临床试验（Puma-ALI-1201；NCT06369285），ALISertib联合内分泌治疗，用于治疗激素受体阳性（HR+），人表皮生长因子受体2阴性（HER2阴性）复发或转移性乳腺癌患者，这些患者先前曾接受过CDK 4/6抑制剂治疗，并在复发或转移环境中接受过至少两种内分泌治疗。

The ALISCA™-Breast1 trial will enroll up to 150 patients who will be randomized (1:1:1) to receive alisertib dosed at either 30 mg, 40 mg or 50 mg twice daily on days 1-3, 8-10 and 15-17 in a 28-day cycle in combination with the endocrine therapy of the investigator’s choice. Patients must provide blood and tissue specimens so that biomarkers can be analyzed..

ALISCA™-Breast1试验将招募多达150名患者，这些患者将被随机（1:1:1）接受阿利替尼，剂量为30 mg，40 mg或50 mg，每天两次，在第1-3天，第8-10天和第15-17天，以28天为周期，结合研究者选择的内分泌治疗。患者必须提供血液和组织标本，以便分析生物标志物。。

The primary objective of the trial is to determine the optimal alisertib dose in combination with selected endocrine therapy. The primary endpoints of the trial include objective response rate, duration of response, disease control rate, progression-free survival, and overall survival. As a secondary endpoint, Puma will evaluate each of these efficacy endpoints within biomarker subgroups in order to determine whether any biomarker subgroup correlates with response.

该试验的主要目的是确定与选定内分泌治疗相结合的最佳alisertib剂量。该试验的主要终点包括客观缓解率，缓解持续时间，疾病控制率，无进展生存期和总生存期。作为次要终点，Puma将评估生物标志物亚组中的每个功效终点，以确定任何生物标志物亚组是否与反应相关。

Puma will perform its biomarker analysis of the ALISCA™-Breast1 trial in parallel with the execution of the clinical trial. Puma plans to perform an initial interim analysis for the evaluation of safety and efficacy..

Puma将在执行临床试验的同时进行ALISCA™BRAST1试验的生物标志物分析。Puma计划进行初步中期分析，以评估安全性和有效性。。

Based upon the outcomes of the trial, Puma anticipates meeting with the U.S. Food and Drug Administration to explore the potential for an approval pathway for alisertib in HER2-negative, HR+ metastatic breast cancer. Once the optimal alisertib dose is identified, Puma plans to engage with global regulatory agencies regarding the design of a pivotal (Phase III) trial, which it anticipates will be a randomized trial of alisertib plus investigator’s choice endocrine therapy versus placebo plus investigator’s choice endocrine therapy in patients with HER2-negative, HR+ metastatic breast cancer..

根据试验结果，Puma预计将与美国食品和药物管理局（FDA）会面，以探索在HER2阴性，HR+转移性乳腺癌中阿利塞替尼批准途径的潜力。一旦确定了最佳alisertib剂量，Puma计划与全球监管机构合作设计一项关键（III期）试验，预计该试验将是alisertib加研究者选择内分泌治疗与安慰剂加研究者选择内分泌治疗在HER2阴性，HR+转移性乳腺癌患者中的随机试验。。

“Additional therapies are needed for patients with HER2-negative, HR+ metastatic breast cancer whose disease progresses on CDK4/6 inhibitors in the first-line setting,” said Joyce A. O’Shaughnessy, M.D., the Celebrating Women Chair in Breast Cancer Research at Baylor University Medical Center, Texas Oncology, Sarah Cannon Research Institute in Dallas, Texas.

德克萨斯州达拉斯市萨拉·坎农研究所贝勒大学医学中心乳腺癌研究庆祝女性主席乔伊斯·奥肖内西（JoyceA.O'Shaughnessy，M.D.）说：“对于HER2阴性、HR+转移性乳腺癌患者，其疾病在一线环境中通过CDK4/6抑制剂进展，需要额外的治疗。”。

“The results from the TBCRC 041 trial indicated that alisertib has impressive clinical activity in the setting of endocrine therapy and CDK4/6 inhibitor-resistant metastatic breast cancer, with good tolerability. I look forward to the further evaluation of alisertib in the ALISCA™-Breast1 trial to definitively determine the clinical impact of this treatment.”.

“TBCRC 041 试验的结果表明，在内分泌治疗和 CDK4/6 抑制剂耐药的转移性乳腺癌中，alisertib 具有令人印象深刻的临床活性和良好的耐受性。我期待着在 ALISCA™-Breast1 试验中进一步评估 alisertib，以最终确定这种治疗方法的临床效果。

Alan H. Auerbach, Chief Executive Officer, President and Founder of Puma, stated, “We are excited to initiate this Phase II trial and to move forward with the development of alisertib in HER2-negative HR+ metastatic breast cancer. We believe that the data from the previous trial of alisertib monotherapy (published in Lancet Oncology) as well as the TBCRC 041 trial (published in JAMA Oncology), which tested alisertib alone and with fulvestrant, and the randomized trial of alisertib plus paclitaxel versus paclitaxel alone (published in JAMA Network Open) have demonstrated that alisertib is active in patients with HER2-negative, HR+ metastatic breast cancer and in biomarker focused subgroups.

Puma首席执行官、总裁兼创始人艾伦·奥尔巴赫（Alan H.Auerbach）表示：“我们很高兴启动这项II期临床试验，并推动alisertib在HER2阴性HR+转移性乳腺癌中的发展。我们相信，先前的alisertib单药治疗试验（发表在《柳叶刀肿瘤学》上）和TBCRC 041试验（发表在《JAMA肿瘤学》上）的数据表明，alisertib联合紫杉醇与单独紫杉醇的随机试验（发表在JAMA Network Open上）对HER2阴性HR+转移性乳腺癌患者有效以及以生物标志物为重点的亚组。

We look forward to enrollment in the ALISCA™-Breast1 trial and anticipate that we should have initial data from this trial in 2025.”.

我们期待着参加ALISCA™BRAST1试验，并预计2025年我们将获得该试验的初步数据。”。

About Puma Biotechnology

关于Puma Biotechnology

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), in 2011. 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于2011年将全球开发和商业化权利授予PB272（neratinib，oral）。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 HR+, 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..

NERLYNX于2018年获得欧盟委员会的上市授权，用于对早期HR+，HER2过表达/扩增乳腺癌的成年患者进行扩展辅助治疗，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®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就抗癌药物alisertib（一种选择性小分子口服极光激酶a抑制剂）的开发和商业化签订了独家许可协议。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。

In February 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with extensive-stage small cell lung cancer. In November 2024, Puma initiated ALISCA™-Breast1, a Phase II clinical trial of alisertib in combination with endocrine therapy for the treatment of patients with HER2-negative, HR+ metastatic breast cancer..

2024 年 2 月，Puma 启动了 ALISCA™-Lung1 的 II 期临床试验，采用 alisertib 单药治疗广泛期小细胞肺癌患者。2024 年 11 月，Puma 启动了 ALISCA™-Breast1，这是一项阿利塞替联合内分泌疗法治疗 HER2 阴性、HR+ 转移性乳腺癌患者的 II 期临床试验。