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Puma Biotechnology Presents Efficacy and Safety Outcomes from the Phase III NALA Trial at the 2020 SABCS
Results show improved CNS outcomes with neratinib-based regimens in the treatment and prevention of CNS metastases from HER2-positive breast cancer LOS
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[{"type":"text","content":"\nResults show improved CNS outcomes with neratinib-based regimens in the treatment and prevention of CNS metastases from HER2-positive breast cancer\n\n LOS ANGELES--(BUSINESS WIRE)--\nPuma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, presented efficacy and safety outcomes in a subgroup of patients from the NALA trial who had central nervous system (CNS) metastases at baseline, with a particular focus on CNS-specific endpoints, at the 2020 Virtual San Antonio Breast Cancer Symposium (SABCS) that is currently taking place. The presentation, entitled “Impact of neratinib plus capecitabine on outcomes in HER2-positive metastatic breast cancer patients with central nervous system disease at baseline: Findings from the phase 3 NALA trial,” is being presented at a Spotlight Poster Discussion Session by Cristina Saura, M.D., Ph.D., Head of Breast Cancer Unit, Vall d’Hebrón University Hospital, an investigator of the trial. A copy of this poster presentation is available on the Puma website.\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201211005419/en/\nThe Phase III NALA trial was a randomized controlled trial of neratinib plus capecitabine (N+C) versus Tykerb® (lapatinib) plus capecitabine (L+C) in patients with third-line HER2-positive metastatic breast cancer (NCT01808573). The trial enrolled 621 patients who were randomized (1:1) to receive either N+C or L+C. The co-primary endpoints of the trial were independently adjudicated progression free survival (PFS) and overall survival (OS). The NALA study met its primary endpoint, with the neratinib arm having significantly improved PFS vs. the lapatinib arm (hazard ratio [HR], 0.76; 95% confidence interval [CI], 0.63-0.93; stratified log-rank P = .0059; mean PFS 8.8 mo vs. 6.6 mo). The data showed no statistical difference in OS between treatment arms (HR 0.88; 95% CI, 0.72-1.07; P = .2098). Time to intervention for symptomatic central nervous system disease (also referred to as brain metastases) was a predefined secondary endpoint of the trial. In the ITT population, significantly fewer interventions for CNS disease occurred with N+C versus L+C (cumulative incidence, 22.8% vs. 29.2%; P = .043).\n\nThe poster presented at the 2020 SABCS meeting describes results for the subset of patients who entered t...