Puma Biotechnology Announces Initiation of ALISCA-Lung1 Phase II Trial of Alisertib in Small Cell Lung Cancer

Rhea-AI Summary

Puma Biotechnology, Inc. (PBYI) commences ALISertib in CAncer Phase II trial for small cell lung cancer patients who have progressed on previous treatments. The trial aims to evaluate alisertib monotherapy's efficacy with primary and secondary endpoints focusing on response rates, survival, and biomarker analysis.

Insights

Oncology Doctor

The initiation of the ALISCA-Lung1 Phase II trial by Puma Biotechnology to evaluate alisertib in patients with extensive stage small cell lung cancer (SCLC) is a significant development in the field of oncology. SCLC is known for its aggressive nature and poor prognosis, making the search for effective treatments critical. Alisertib targets aurora kinase A, a protein implicated in cell division and its potential efficacy in SCLC could offer a new avenue for therapy, especially in the subset of patients with specific molecular markers. The focus on biomarker subgroups in this trial is particularly noteworthy, as personalized medicine becomes increasingly important in cancer treatment.

Medical Research Analyst

From a research perspective, the design of the ALISCA-Lung1 trial is robust, with clear primary and secondary endpoints such as objective response rate and overall survival. The inclusion of biomarker analysis is a forward-thinking approach that aligns with current trends in oncology research, emphasizing the importance of targeted therapies. The interim analysis for biomarker evaluation and efficacy will be crucial for determining the future of alisertib, potentially leading to an accelerated approval pathway if the results are favorable. The trial's outcomes may have significant implications for Puma Biotechnology's stock, particularly if alisertib shows promise in a therapeutic area with high unmet needs.

Market Research Analyst

Analyzing the market implications, the success of alisertib in the ALISCA-Lung1 trial could have a substantial impact on Puma Biotechnology's market position. The current treatment landscape for SCLC is limited and new effective therapies are in high demand. A positive outcome from this trial could position Puma as a leader in SCLC treatment, potentially leading to an increase in stock value. Investors will be closely monitoring the trial's progress and interim analysis results, as these will provide early indications of the drug's market potential and its impact on Puma's financial future.

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. 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.

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

“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. “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. 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.”

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), 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.

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.

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, 2022 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/20240213029980/en/

Alan H. Auerbach or Mariann Ohanesian, Puma Biotechnology, Inc., +1 424 248 6500

info@pumabiotechnology.com

ir@pumabiotechnology.com

David Schull, Russo Partners, +1 212 845 4200

david.schull@russopartnersllc.com

Source: Puma Biotechnology, Inc.

FAQ

What is the purpose of Puma Biotechnology's (PBYI) ALISCA-Lung1 Phase II trial?

The purpose is to evaluate alisertib monotherapy in patients with extensive stage small cell lung cancer who have failed first-line platinum-based chemotherapy and immunotherapy.

How many patients will be enrolled in the ALISCA-Lung1 trial?

Up to 60 patients will be enrolled in the trial.

What is the dosing schedule for alisertib in the trial?

Alisertib is dosed at 50 mg BID on days 1-7 of every 21-day cycle.

What are the primary and secondary endpoints of the trial?

The primary endpoint is objective response rate, with secondary endpoints including duration of response, disease control rate, progression-free survival, and overall survival.

What will Puma Biotechnology analyze in the trial's biomarker subgroups?

Puma will assess whether there is enhanced efficacy in any biomarker subgroup and perform biomarker analysis in parallel with the clinical trial.