Puma Biotech's Nerlynx Ups Survival In Third-Line Breast Cancer
Zacks Investment Research | Dec 17, 2018 10:20PM ET
Puma Biotechnology, Inc. (NASDAQ:PBYI) announced positive top-line results from the phase III NALA study, evaluating its only marketed drug, Nerlynx (neratinib), for the treatment of third-line hormone receptor-positive (HER2-positive) metastatic breast cancer.
We would like to remind investors that in September this year, Puma Biotech received the EU approval for Nerlynx as an extended adjuvant treatment of early stage HER2-positive breast cancer in patients, previously treated with Roche’s Herceptin-based adjuvant therapy. The drug was approved for the same indication in the United States in July 2017.
The NALA study evaluated a combination of Nerlynx and Roche’s (OTC:RHHBY) Xeloda (capecitabine) as compared to Novartis' (NYSE:NVS) Tykerb (lapatinib) plus Xeloda in patients with HER2-positive metastatic breast cancer, who have failed two or more prior lines of HER2-directed treatments.
The study enrolled 621 patients. The co-primary endpoints of the same are centrally confirmed progression free survival (PFS) and overall survival (OS). Notably, the study was to be considered positive if either of the co-primary endpoints were found to be positive.
Data from the study showed that patients, who received Nerlynx + Xeloda, experienced a statistically significant improvement in centrally confirmed PFS compared with those who were administered with Tykerb + Xeloda. However, the combo regime of Nerlynx + Xeloda led to an improved OS but failed to achieve a statistical significance.
Puma Biotech will submit the study’s full and final results to global health and regulatory authorities and present the same at a future medical conference in 2019. If the company gets an approval to include the NALA study outcome on Nerlynx’s label, it will be eligible to treat a broader breast cancer population, which can drive sales higher.
Shares of Puma Biotech have plummeted 78.3% so far this year, significantly wider than the Zacks Investment Research
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