Pfizer (NYSE:PFE) announces that, based on a futility analysis by the independent Data Monitoring Committee, a Phase 3 clinical trial, PALLAS, evaluating Ibrance (palbociclib) and adjuvant endocrine therapy in patients with HR+/HER2- breast cancer is unlikely to achieve the primary endpoint of a statistically significant effect on invasive disease-free survival compared to endocrine therapy alone.
No new safety signals were observed.
Study participants will be advised by their doctors on next steps. Long-term follow-up will continue as planned.
Complete results will be released at a later date.
The FDA approved the kinase inhibitor for women with HR+/HER2- breast cancer in February 2016 and men with HR+/HER2- breast cancer in April 2019.
Despite the setback, CEO Albert Bourla "remains confident" that the company can achieve its goal of at least a 6% compound annual growth rate through 2025.
