Pfizer PFE announced that an independent Data Monitoring Committee (DMC) has recommended that a large phase III PALLAS study evaluating its blockbuster drug Ibrance (palbociclib) in early breast cancer is unlikely to show statistically significant improvement in its primary endpoint of invasive disease-free survival (iDFS).
Pfizer’s shares were down more than 6% in after-hours trading on May 29, in response to the news. Pfizer’s shares have declined 2.5% this year so far compared with a decrease of 0.5% for the industry.
The study compared Ibrance plus standard adjuvant endocrine therapy to standard adjuvant endocrine therapy alone in pre- and postmenopausal women or men with HR+, HER2- early invasive (stage 2 and stage 3) breast cancer, including those at moderate-to-high risk of recurrence
The study is co-sponsored by the Austrian Breast & Colorectal Cancer Study Group and Alliance Foundation Trials along with Pfizer and involves more than 400 centers in 21 countries worldwide.
Presently, Ibrance is marketed for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women or in men. It is also approved in combination with AstraZeneca’s AZN Faslodex (fulvestrant) for advanced breast cancer in patients with disease progression following endocrine therapy. Please note that Ibrance is not yet approved to treat any early breast cancer indication. Another phase III PENELOPE-B study is evaluating Ibrance in patients with high-risk early breast cancer. Data from the study are expected this year.
Ibrance is a key revenue driver for Pfizer and generated sales of $1.25 billion in the first quarter of 2020. The failure of the PALLAS study was a major setback for Pfizer. If Ibrance would have been approved for an early breast cancer indication, based on the PALLAS study, it would have been eligible to treat a much larger breast cancer population and bring in more revenues for Pfizer.
However, competition in the breast cancer market has risen with the launch of Eli Lilly’s LLY Verzenio and Novartis’ NVS Kisqali in 2-3 years. Nonetheless, in key markets like the United States, Europe and Japan, Ibrance has maintained a major market share of total CDK inhibitors class volume despite rising competition.
Pfizer currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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