NALA Trial: Neratinib Versus Lapatinib Combination Therapy for Metastatic Breast Cancer
Posted: Friday, July 19, 2019
The randomized, open-label phase III NALA trial showed that the combination of neratinib (an irreversible pan-HER tyrosine kinase inhibitor) and capecitabine improved progression-free survival in patients with stage IV HER2-positive metastatic breast cancer when compared with a combination of capecitabine and lapatinib (a reversible dual tyrosine kinase inhibitor). Cristina Saura, MD, PhD, of Vall d’Hebron University Hospital, Spain, presented these data, which revealed a trend toward improved overall survival with neratinib/lapatinib, at the 2019 American Society for Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 1002).
A total of 621 patients with stage IV HER2-positve metastatic breast cancer were randomly assigned 1:1 to receive either neratinib plus capecitabine or lapatinib plus capecitabine. All study patients had received at least two prior HER2-directed therapies for their metastatic disease.
For patients treated with the neratinib combination, the risk of disease progression or death was reduced by 24% compared with the lapatinib combination. The 12-month progression-free survival rates for neratinib and lapatinib were 37.8% and 14.8%, respectively. Overall survival for neratinib at 12 months was 87.5%, whereas for the lapatinib combination, it was 66.7%. The overall response rate in patients who had a measurable disease at screening improved with neratinib plus capecitabine (32.8%) compared with lapatinib plus capecitabine (26.7%). Additionally, the time to intervention for symptomatic central nervous system disease was delayed for patients taking neratinib compared with those taking lapatinib.
The incidence of adverse events related to treatment was similar between the two groups. However, there was a higher rate of grade 3 diarrhea for patients taking the neratinib combination (24.4% vs. 12.5% with lapatinib). Fewer patients who received neratinib had treatment-emergent adverse events leading to discontinuation of the therapy (10.9%) compared with lapatinib (14.5%).
Disclosure: The study authors’ disclosure information may be found at coi.asco.org.
