Puma Biotechnology Announces Initiation of ALISCA™-Breast1 Phase II Trial of Alisertib in Hormone Receptor-Positive, HER2-Negative Metastatic Breast Cancer
Puma Biotechnology (NASDAQ: PBYI) has initiated the ALISCA™-Breast1 Phase II trial of alisertib combined with endocrine therapy for hormone receptor-positive, HER2-negative metastatic breast cancer patients. The study will enroll up to 150 patients who have previously received CDK 4/6 inhibitors and at least two prior endocrine therapies. Patients will be randomized to receive alisertib at 30mg, 40mg, or 50mg doses. The trial's primary endpoints include objective response rate, duration of response, disease control rate, progression-free survival, and overall survival. Initial data is expected in 2025, with plans to discuss potential approval pathways with the FDA following trial outcomes.
Puma Biotechnology (NASDAQ: PBYI) ha avviato il trial di fase II ALISCA™-Breast1 per l'alisertib combinato con terapia endocrina per pazienti con cancro al seno metastatico positivo ai recettori ormonali e negativo per HER2. Lo studio prevederà l'arruolamento di fino a 150 pazienti che hanno precedentemente ricevuto inibitori CDK 4/6 e almeno due terapie endocrine. I pazienti saranno randomizzati per ricevere alisertib a dosaggi di 30mg, 40mg o 50mg. Gli endpoint primari dello studio includono il tasso di risposta obiettiva, la durata della risposta, il tasso di controllo della malattia, la sopravvivenza libera da progressione e la sopravvivenza complessiva. I dati iniziali sono attesi nel 2025, con piani per discutere le potenziali strade di approvazione con la FDA dopo i risultati dello studio.
Puma Biotechnology (NASDAQ: PBYI) ha iniciado el ensayo de fase II ALISCA™-Breast1 que combina alisertib con terapia endocrina para pacientes con cáncer de mama metastásico positivo para receptores hormonales y negativo para HER2. El estudio inscribirá hasta 150 pacientes que hayan recibido previamente inhibidores de CDK 4/6 y al menos dos terapias endocrinas. Los pacientes serán aleatorizados para recibir alisertib en dosis de 30mg, 40mg o 50mg. Los objetivos primarios del ensayo incluyen la tasa de respuesta objetiva, la duración de la respuesta, la tasa de control de la enfermedad, la supervivencia libre de progresión y la supervivencia global. Se esperan datos iniciales en 2025, con planes para discutir posibles vías de aprobación con la FDA tras los resultados del ensayo.
푼마 바이오테크놀로지 (NASDAQ: PBYI)는 호르몬 수용체 양성, HER2 음성 전이성 유방암 환자에게 내분비 요법과 병합한 알리서티브의 ALISCA™-Breast1 2상 시험을 시작했습니다. 이 연구는 이전에 CDK 4/6 억제제를 사용한 적이 있고 최소 두 가지 내분비 요법을 받은 150명까지의 환자를 등록할 것입니다. 환자들은 30mg, 40mg 또는 50mg 용량의 알리서티브를 임의로 배정받게 됩니다. 시험의 주요 목표는 객관적 반응률, 반응 지속 기간, 질병 관리율, 무진행 생존 및 전체 생존을 포함합니다. 초기 데이터는 2025년에 예상되며, 시험 결과에 따라 FDA와 잠재적 승인 경로를 논의할 계획입니다.
Puma Biotechnology (NASDAQ: PBYI) a lancé l'essai de phase II ALISCA™-Breast1 sur l'alisertib combiné avec une thérapie endocrinienne pour les patients atteints de cancer du sein métastatique positif aux récepteurs hormonaux et négatif pour HER2. L'étude recrutera jusqu'à 150 patients ayant précédemment reçu des inhibiteurs de CDK 4/6 et au moins deux thérapies endocriniennes. Les patients seront randomisés pour recevoir de l'alisertib à des doses de 30mg, 40mg ou 50mg. Les principaux critères d'évaluation de l'essai comprennent le taux de réponse objectif, la durée de la réponse, le taux de contrôle de la maladie, la survie sans progression et la survie globale. Les premières données sont attendues en 2025, avec des plans pour discuter des voies potentielles d'approbation avec la FDA après les résultats de l'essai.
Puma Biotechnology (NASDAQ: PBYI) hat die ALISCA™-Breast1 Phase-II-Studie zu Alisertib in Kombination mit einer endokrinen Therapie bei hormonrezeptor-positiven, HER2-negativen metastasierten Brustkrebspatientinnen initiiert. Die Studie wird bis zu 150 Patienten einschreiben, die zuvor CDK 4/6-Inhibitoren und mindestens zwei endokrine Therapien erhalten haben. Die Patienten werden randomisiert und erhalten Alisertib in Dosen von 30mg, 40mg oder 50mg. Die primären Endpunkte der Studie umfassen die objektive Ansprechrate, die Dauer des Ansprechens, die Krankheitskontrollrate, die progressionsfreie Überlebenszeit und das Gesamtüberleben. Erste Daten werden für 2025 erwartet, mit Plänen, nach den Ergebnissen der Studie mögliche Genehmigungswege mit der FDA zu besprechen.
- Initiation of new Phase II trial expanding the company's oncology pipeline
- Previous trials demonstrated alisertib's activity in target patient population
- Clear pathway to potential FDA approval and Phase III trial
- Initial trial data not expected until 2025
- Will require additional Phase III trial before potential approval
- Multiple competing therapies already exist in the breast cancer market
Insights
This Phase II trial initiation for alisertib represents a significant milestone in addressing an important unmet medical need in breast cancer treatment. The study's design with 150 patients across three dosing arms is robust and well-structured to determine optimal dosing. The trial's focus on HR+/HER2- breast cancer patients who have progressed after CDK4/6 inhibitors is particularly strategic, as this represents a growing patient population with treatment options.
The inclusion of biomarker analysis parallel to the clinical trial adds substantial value, potentially enabling identification of patient subgroups most likely to benefit from treatment. Previous data from multiple published studies in prestigious journals (Lancet Oncology, JAMA Oncology and JAMA Network Open) showing alisertib's activity provides a strong foundation for this new trial. The planned interim analysis and regulatory engagement strategy suggest a well-thought-out development pathway toward a potential Phase III trial.
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. 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.
Based upon the outcomes of the trial, Puma anticipates meeting with the
“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
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. We look forward to enrollment in the ALISCA™-Breast1 trial and anticipate that we should have initial data from this trial in 2025.”
About 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
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. 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.
Further information about Puma Biotechnology may be found at https://www.pumabiotechnology.com.
Forward-Looking Statements
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. 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, 2023 and subsequent reports. 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20241120479300/en/
Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500
info@pumabiotechnology.com
ir@pumabiotechnology.com
David Schull or Olipriya Das, Russo Partners, +1 212 845 4200
david.schull@russopartnersllc.com
olipriya.das@russopartnersllc.com
Source: Puma Biotechnology, Inc.
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