Puma Biotechnology has reported positive top-line results from the Phase III NALA trial of PB272 (neratinib) plus capecitabine against tykerb (lapatinib) plus capecitabine for the treatment of patients with HER2-positive metastatic breast cancer.
The controlled trial enrolled 621 HER2-positive metastatic breast cancer patients who had failed two or more prior lines of HER2-directed treatments in the metastatic disease setting.
Patients were randomised in 1:1 ratio to receive either neratinib plus capecitabine or lapatinib plus capecitabine.
The trial’s co-primary endpoints were centrally confirmed progression-free survival (PFS) and overall survival (OS).
Secondary endpoints included the time to intervention for symptomatic central nervous system disease.
It was carried out at sites in North America, Europe, Asia-Pacific and South America.
The latest findings showed that patients treated with neratinib plus capecitabine achieved a statistically significant improvement in centrally confirmed PFS compared to those treated with lapatinib plus capecitabine.
It was reported that treatment with neratinib plus capecitabine did not bring any statistical improvement in OS.
Results also showed that treatment with neratinib plus capecitabine resulted in an improvement over the lapatinib plus capecitabine combination.
The trial reported a similar safety profile to the ones observed in previous clinical studies of neratinib.
Puma Biotechnology CEO and president Alan Auerbach said: “We look forward to working with the regulatory authorities in the hope of bringing another potential treatment option to patients with HER2-positive metastatic breast cancer as soon as possible.”
The company is expected to present full results from the NALA trial to the global health authorities, including the US Food and Drug Administration and European Medicines Agency.