IDMC reports phase III PALLAS trial of Ibrutinib unlikely to meet endpoint in early breast cancer.- Pfizer

Pfizer reports that following a preplanned efficacy and futility analysis, the independent Data Monitoring Committee (DMC) of the collaborative Phase III early breast cancer PALbociclib CoLlaborative Adjuvant Study (PALLAS) determined that the trial of Ibrance (palbociclib) plus standard adjuvant endocrine therapy is unlikely to show a statistically significant improvement in the primary endpoint of invasive disease-free survival (iDFS). Patients currently receiving palbociclib in the study will be advised about next steps by their physicians and long-term follow up of all patients will proceed as planned. No unexpected new safety signals were observed in patients receiving palbociclib. The PALLAS trial compares palbociclib plus standard adjuvant endocrine therapy to standard adjuvant endocrine therapy alone in women and men with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) early (stage 2 and 3) breast cancer and is an academically-led global collaboration, involving more than 400 centers in 21 countries around the globe. Health authorities and trial investigators have been notified of this decision. When available, the full results from the PALLAS study will be shared with the scientific community at a later date.