Pfizer Presents Real-World Evidence of Ibrance for HR+, HER- Breast Cancer


Palbociclib is indicated for adults in combination with an aromatase inhibitor as initial endocrine-based therapy in postmenopausal women or in men.

Real-world evidence demonstrated an associated benefit for individuals treated with palbociclib (Ibrance) in combination with an aromatase inhibitor (AI) compared with AI alone in the first-line setting, Pfizer announced at the European Society for Medical Oncology Breast Cancer 2022 Congress.

“Since its approval, palbociclib has generated promising results for adults diagnosed with HR+, HER2- mBC, and this latest analysis reflects Pfizer’s commitment to use real-world evidence to complement traditional randomized clinical trials to better understand the effectiveness of palbociclib as a first-line treatment option in combination with an AI for this patient population,” Chris Boshoff, MD, PhD, chief development officer of oncology at Pfizer Global Product Development, said in a statement.

The cohort study is a large comparative effectiveness study of 2888 individuals who have hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC).

Investigators evaluated palbociclib in combination with AI compared with AI alone, and it demonstrated an associated improved overall survival in post-menopausal women and in men with HR+, HER2- mBC treated in routine clinical practice in the United States.

After balancing for baseline clinical and demographic characteristics, median overall survival was significantly longer in the palbociclib arm compared with the AI group. Additionally, the real-world median progression-free survival was 19.3 months compared with 13.9 months, respectively.

The findings also represent a 24% reduction in the risk of death and a 30% reduction in the risk of progression. Safety data were not collected as part of the analysis.

“It is encouraging to see associated improved overall survival extend beyond my own practice in the real-world setting, and these additional results, along with clinical trial data, may help health care providers make more fully informed treatment decisions for their patients,” Hope Rugo, MD, lead researcher and professor of medicine at the University of California San Francisco’s Helen Diller Family Comprehensive Cancer Center, said in the statement.

The FDA approved palbociclib more than 7 years ago, and since then, it has been prescribed to more than 450,000 individuals across more than 100 countries, according to the statement.

The real-world evidence program is generating data from multiple studies that involve more than 8000 individuals around the world, and it continues to expand. Pfizer will continue to share new data of real-world evidence from these studies as the results become available.

Palbociclib is indicated for the treatment of adults with HR+, HER2- advanced or metastatic breast cancer in combination with an AI as initial endocrine-based therapy in postmenopausal women or in men, or with fulvestrant in individuals with disease progression following endocrine therapy.

The poster, “Overall Survival With First-Line Palbociclib Plus an Aromatase Inhibitor (AI) vs AI in Metastatic Breast Cancer: A Large Real-World Database Analysis,”was on display at the congress on May 4, 2022 and can be accessed for those who are registered for the congress.


Pfizer presents positive real-world evidence for first-line Ibrance (palbociclib) combination therapy in HR+, HER2- metastatic breast cancer at ESMO Breast Cancer 2022. Pfizer. News release. May 4, 2022. Accessed May 4, 2022.

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