Ahead of the American Society of Clinical Oncology (ASCO) annual meeting, Puma Biotechnology released an abstract detailing results from the phase 3 NALA trial, which compared the company’s Nerlynx (neratinib), in combination with Roche’s chemotherapy drug Xeloda (capecitabine), to Novartis’ Tykerb (lapatinib) and Xeloda in patients with breast cancer. The Nerlynx-Xeloda combination outperformed the Tykerb-Xeloda combination.
NALA was a multinational, randomized, open-label trial and enrolled 621 patients with stage IV HER2+ metastatic breast cancer who had received two or more previous HER2-directed treatments. Patients were randomized 1:1 to receive Nerlynx and Xeloda or Tykerb and Xeloda. Co-primary endpoints were progression-free survival (PFS) and overall survival (OS). PFS for the Nerlynx-Xeloda cohort at 6 and 12 months were 47% and 38%, respectively. For the Tykerb-Xeloda cohort, the PFS at 6 and 12 months were 29% and 15%, respectively. In addition, overall survival at the same time points was higher for the Nerlynx-Xeloda group (33%) compared the Tykerb-Xeloda group (27%), but this wasn’t statistically significant.
Puma Biotechnology plans to file a new drug application with the FDA in the summer of 2019 requesting approval for neratinib in third-line metastatic breast cancer based on the results of the Phase III trial.
About Stage IV HER2+ Metastatic Breast Cancer
Stage IV breast cancer means the cancer has metastasized, or traveled, through the bloodstream to create tumors in the liver, lungs, brain, bones and/or other parts of the body. Between 20 and 30 percent of women with early stage breast cancer go on to develop metastatic disease. While treatable, metastatic breast cancer (MBC) cannot be cured. The five-year survival rate for stage IV breast cancer is 22 percent; median survival is three years. Annually, the disease takes 40,000 lives.
Neratinib is a kinase inhibitor that irreversibly binds to Epidermal Growth Factor Receptor (EGFR), Human Epidermal Growth Factor Receptor 2 (HER2), and HER4.
Nerlynx has been approved by the FDA for the extended adjuvant treatment of adult patients with early-stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.