Ibrance – pro
On April 15, 2015 Pfizer Inc. (NYSE:PFE) announced that the Phase 3 PALOMA-3 trial for IBRANCE® (palbociclib) met its primary endpoint of demonstrating an improvement in progression-free survival (PFS) for the combination of IBRANCE plus fulvestrant compared with fulvestrant plus placebo in women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer following disease progression during or after endocrine therapy. The study was stopped early due to efficacy based on an assessment by an independent Data Monitoring Committee (DMC). These are the first randomized Phase 3 trial results for IBRANCE, a new anti-cancer medicine with the novel mechanism of cyclin-dependent kinase 4/6 (CDK 4/6) inhibition.
IBRANCE was approved by the U.S. Food and Drug Administration (FDA) in February 2015 as a first-line treatment for women with advanced or metastatic estrogen receptor positive, human epidermal growth factor receptor 2 negative (ER+/HER2-) breast cancer. IBRANCE® (palbociclib), in combination with letrozole, is indicated for the treatment of postmenopausal women with ER+/HER2- advanced breast cancer as initial endocrine-based therapy for their metastatic disease.
More recently, the PALOMA study has found that Ibrance combined with the hormonal therapy Faslodex (chemical name: fulvestrant) more than doubled progression-free survival compared to Faslodex alone in postmenopausal women diagnosed with hormone-receptor-positive, HER2-negative advanced-stage breast cancer that had grown while being treated with first-line hormonal therapy. The combination use is for the treatment of women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced or metastatic breast cancer (MBC) whose cancer has progressed after endocrine therapy.
Nicholas C. Turner, Jungsil Ro, Fabrice Andre, Sherene Loi, Sunil Verma, Hiroji Iwata, Nadia Harbeck, Sibylle Loibl, Cynthia Huang Bartlett, Ke Zhang, Carla Giorgetti, Sophia Randolph, Maria Koehler, Massimo Cristofanilli; Royal Marsden, London & Surrey, United Kingdom; Natl Cancer Ctr, Goyang-si, Korea South; Institut Gustave Roussy, Villejuif, France; Peter MacCallum Cancer Centre, East Melbourne, Australia; Sunnybrook Odette Cancer Centre, Toronto, ON, Canada; Aichi Cancer Center Hospital, Nagoya, Japan; University of Munich, Otterfing, Germany; German Breast Group, Neu-Isenburg, Germany; Pfizer Oncology, New York, NY; Pfizer Inc, San Diego, CA; Pfizer, Milan, Italy; Pfizer Oncology, La Jolla, CA; Pfizer Oncology, Narberth, PA; Thomas Jefferson University, Philadelphia, PA, PALOMA3: A double-blind, phase III trial of fulvestrant with or without palbociclib in pre- and post-menopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer that progressed on prior endocrine therapy. J Clin Oncol 33, 2015 (suppl; abstr LBA502)
Nicholas C. Turner, M.D., Ph.D., Jungsil Ro, M.D., Fabrice André, M.D., Ph.D., Sherene Loi, M.D., Ph.D., Sunil Verma, M.D., Hiroji Iwata, M.D., Nadia Harbeck, M.D., Sibylle Loibl, M.D., Cynthia Huang Bartlett, M.D., Ke Zhang, Ph.D., Carla Giorgetti, Ph.D., Sophia Randolph, M.D., Ph.D., Maria Koehler, M.D., Ph.D., and Massimo Cristofanilli, M.D., Palbociclib in Hormone-Receptor–Positive Advanced Breast Cancer
N Engl J Med 2015; 373:209-219
Richard S Finn, MD, Prof John P Crown, MD, Istvan Lang, MD, Katalin Boer, MD, Prof Igor M Bondarenko, MD, Sergey O Kulyk, MD, Johannes Ettl, MD, Ravindranath Patel, MD, Tamas Pinter, MD, Marcus Schmidt, MD, Yaroslav Shparyk, MD, Anu R Thummala, MD, Nataliya L Voytko, MD, Camilla Fowst, MD, Xin Huang, PhD, Sindy T Kim, BS, Sophia Randolph, MD, Prof Dennis J Slamon, The cyclin-dependent kinase 4/6 inhibitor palbociclib in combination with letrozole versus letrozole alone as first-line treatment of oestrogen receptor-positive, HER2-negative, advanced breast cancer (PALOMA-1/TRIO-18): a randomised phase 2 study. Lancet Volume 16, No. 1, p25–35, January 2015
References: IBRANCE® (palbociclib) Prescribing Information. New York. NY: Pfizer Inc: 2015.
Erica L. Mayer, Adrienne Brana Gropper, Nadine M. Tung, Michaela Jane Higgins, Tiffany A. Traina, William Thomas Barry, Eric P. Winer, Harold J. Burstein; JAdjuvant palbociclib (P) plus endocrine therapy (ET) for hormone receptor positive (HR+) breast cancer: A phase II feasibility study. J Clin Oncol 32:5s, 2014 (suppl; abstr TPS654)