Ibrance misses main endpoint in breast cancer study

The collaborative Phase III PENELOPE-B trial of Ibrance (palbociclib) 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, said US pharma giant Pfizer (NYSE: PFE), which conducted the trial in cooperation with the German Breast Group (GBG).

“Reducing the risk of disease recurrence in patients who have residual disease after neoadjuvant chemotherapy is a complex clinical challenge,” said Professor Sibylle Loibl, chairman of GBG, adding: “This unique trial was made possible through the collaboration and support from all the research partners involved. Despite this outcome, we believe that key learnings will emerge from the large number of biomarkers being analyzed from collected tumor tissue, which will help inform future breast cancer research.”