Puma Biotechnology has completed patient enrolment in the Phase III NALA trial of its lead drug candidate PB272 (neratinib) for the treatment of HER2-positive metastatic breast cancer.
The trial of PB272 plus Xeloda versus Tykerb plus Xeloda is designed for patients who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease, and has now been completed.
Around 600 patients who are randomised (1:1) to receive either PB272 plus Xeloda or Tykerb plus Xeloda have been enrolled in the trial, which is being conducted at sites in North America, Europe and Asia-Pacific.
The trial's co-primary endpoints are progression-free survival (PFS) and overall survival (OS).
Puma Biotechnology president and chief executive officer Alan Auerbach said: "We are very pleased to achieve this important milestone for the Phase III NALA trial of neratinib in HER2-positive metastatic breast cancer.
"We look forward to reporting initial data from the study, which we anticipate will occur during the first half of 2018.
"We also look forward to the continued development of neratinib in combination with Kadcyla in HER2-positive metastatic breast cancer (FB-10 trial), in patients with HER2-positive breast cancer that has metastasised to the brain (TBCRC-022 trial), and in patients with HER2 non-amplified tumours that have a HER2 mutation (SUMMIT)."
Puma reached an agreement with the US Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of the Phase III trial.
The European Medicines Agency (EMA) has also provided follow-on scientific advice (SA) consistent with that of the FDA regarding the company's Phase III trial design and endpoints used in the trial.
The company intends to report a primary analysis of PFS during the first half of next year.