Pfizer: 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 Inc. (NYSE:PFE) announced today the presentation of real-world evidence demonstrating an associated benefit for patients treated with IBRANCE® (palbociclib) in combination with an aromatase inhibitor (AI), as compared to AI alone, in the first-line setting, at the European Society for Medical Oncology (ESMO) Breast Cancer 2022 Congress. This retrospective cohort study is a large comparative effectiveness study of 2,888 hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC) patients evaluating IBRANCE in combination with AI compared to AI alone and demonstrated an associated improved overall survival (OS) in post-menopausal women and in men with HR+, HER2- mBC treated in routine clinical practice in the United States.

“Understanding the effectiveness of treatments in a real-world setting is critical to improving cancer care,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “Since its approval, IBRANCE 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 IBRANCE as a first-line treatment option in combination with an AI for this patient population.”

After balancing for baseline demographic and clinical characteristics, median OS (95% CI) was significantly longer in the palbociclib group versus AI group (49.1 [45.2–57.7] vs 43.2 [37.6–48.0] months; hazard ratio (HR) = 0.76 [95% CI, 0.65–0.87]; P=0.0001). Real-world median progression-free survival (95% CI) was 19.3 (17.5–20.7) versus 13.9 (12.5–15.2) months, respectively (HR = 0.70 [95% CI, 0.62–0.78]; P<0.0001) in this observational, retrospective real-world analysis. These findings 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 this analysis.

“I’ve witnessed first-hand the positive impact of palbociclib in combination with endocrine therapy in patients with HR+, HER2- metastatic breast cancer,” said Hope S. Rugo, M.D., lead researcher and professor of medicine at the University of California San Francisco (UCSF) Helen Diller Family Comprehensive Cancer Center. “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 healthcare providers make more fully informed treatment decisions for their patients.”

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” is on display at the ESMO Breast Cancer 2022 Congress on May 4, 2022, and can be accessed starting May 3, 2022, to those registered for the Congress.

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