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.
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"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.