PENELOPE-B trial of Ibrance in early breast cancer did not meet primary endpoint- Pfizer

The German Breast Group (GBG) and Pfizer Inc. announced that the collaborative Phase III PENELOPE-B trial did not meet the primary endpoint of improved invasive disease-free survival (iDFS) in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer (eBC) who have residual invasive disease after completing neoadjuvant chemotherapy. No unexpected safety signals were observed. ?PENELOPE-B is a randomized, double-blind, placebo-controlled Phase III study comparing one year of palbociclib plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy. The trial is sponsored by the GBG as part of a clinical research collaboration with Pfizer and other study groups. "This is the first randomized Phase III study to establish mature iDFS results for a CDK4/6 inhibitor as part of the adjuvant treatment for early breast cancer. While we are disappointed with this result, we look forward to continuing to work with our research partners to understand subgroup data and how these could inform the development of our next-generation CDK inhibitors in early breast cancer,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. .