Pfizer's (PFE) Ibrance Fails in Early Breast Cancer Study
Pfizer, Inc. PFE announced that a phase III study evaluating its blockbuster drug, Ibrance, in patients with high-risk early breast cancer failed to meet the primary endpoint.
The PENELOPE-B study (n= 1,250) compared one year of treatment with Ibrance, a CDK 4/6 inhibitor, plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy in women with HR+, HER2- early breast cancer at high risk of recurrence, who have a residual invasive disease after completing neoadjuvant chemotherapy. The primary endpoint of the study was to show improvement in invasive disease-free survival (iDFS). The study has been sponsored by the German Breast Group (GBG). Detailed findings from the study will be presented at an upcoming medical conference.
Pfizer’s stock has declined 6.1% this year so far against growth of 0.5% for the industry.
In June, Ibrance failed in another phase III early breast cancer study. An independent Data Monitoring Committee (DMC) recommended that a large phase III PALLAS study evaluating Ibrance plus standard adjuvant endocrine therapy in HR+, HER2- early breast cancer is unlikely to show statistically significant improvement in its primary endpoint of iDFS.
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.
Ibrance is a key revenue driver for Pfizer and generated sales of $2.6 billion in the first half of 2020. The failure of the PALLAS and PENELOPE-B studies is a major setback for the company. If Ibrance would have been approved for an early breast cancer indication, based on the PALLAS and PENELOPE-B studies, it would have been eligible to treat a much larger breast cancer population and bring in additional revenues for Pfizer.
Approximately 30% of people diagnosed with HR+, HER2- early breast cancer are at risk of their cancer returning and there is a significant unmet need for medicines, which can reduce the risk of cancer recurrence in early-stage breast cancer patients.
Other CDK4/6 inhibitors currently used to treat metastatic breast cancer are Eli Lilly’s LLY Verzenio and Novartis’ NVS Kisqali. The CDK4 & 6 inhibitor class of medicines work by inhibiting cyclin-dependent kinases 4 and 6, which interferes with the division of cancer cells and helps stop tumor growth. None of the three CDK4 & 6 inhibitor medicines are approved yet to treat any early breast cancer indication. Verzenio is the only CDK4 & 6 inhibitor to demonstrate a statistically significant reduction in the risk of cancer recurrence in early-stage breast cancer patients.
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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