Puma Biotechnology, Inc. 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 RHHBY Xeloda (capecitabine) as compared to Novartis' 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 industry’s decline of 20.7%.
In the first nine months of 2018, Nerlynx generated sales of $139.4 million. However, the metric in the third quarter of 2018 fell below expectations due to higher patient discontinuation.
Apart from the HER2-positive breast cancer indication, Puma Biotech believes that Nerlynx holds great potential for treating multiple cancers including NSCLC and other tumor types, which over-express or have a mutation in HER2. Several additional assessments on Nerlynx targeting different types of breast cancer patient population and in earlier-line settings are currently underway. The drug’s label expansion will allow it to treat and access an extended patient population.
Zacks Rank & Stock to Consider
Puma Biotech currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the healthcare sector is Gilead Sciences, Inc. GILD, which sports a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Gilead’s earnings estimates have moved 4.2% north for 2018 and 2.9% for 2019 over the past 60 days.
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