Our Mission
Puma Biotechnology is a biopharmaceutical company dedicated to the acquisition, development, and commercialization of novel therapeutics for the treatment of cancer.
Clinical Trials
ALISCA™-Lung1
In September 2023, the FDA granted Orphan Drug Designation to alisertib, a selective, small-molecule, orally administered inhibitor of Aurora Kinase A, for the treatment of patients with small cell lung cancer. The FDA grants Orphan Drug Designation to investigational therapies being developed to treat, diagnose, or prevent a rare disease or condition affecting fewer than 200,000 people in the United States. In February of 2024, Puma initiated ALISCA™-Lung1, a Phase II clinical trial of alisertib monotherapy for the treatment of patients with small cell lung cancer.
Small Cell Lung Cancer
ALISCA™-Lung1
A Phase II Study of Alisertib, an Investigational Drug, in Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC).
ABOUT THIS CLINICAL TRIAL
This Phase II study is investigating alisertib monotherapy in patients with small cell lung cancer (SCLC) to determine whether biomarkers correlate with alisertib response. Findings from this study are anticipated to identify a biomarker-defined patient population that derives the greatest clinical benefit from alisertib. Future clinical development of alisertib in SCLC is anticipated to be focused on this biomarker-defined population.
WHO IS ELIGIBLE?
The ALISCA™-Lung1 clinical trial is open to patients 18 years or older with pathologically-confirmed SCLC following progression on or after first-line treatment with one platinum-based chemotherapy and immunotherapy. Up to one additional systemic anti-cancer therapy for SCLC is allowed, for a total of up to two prior lines of therapy. Talk to your doctor to discuss your eligibility.
NOW ENROLLING
Puma anticipates opening the ALISCA™-Lung1 trial at approximately 25 study sites within the United States by the end of 2024. Click here for a list of study sites currently open to enrollment.
FOR MORE INFORMATION ON THIS CLINICAL TRIAL AND LOCATION OF TRIAL SITES:
or email clinicaltrials@pumabiotechnology.com
