Pfizer announces results from PATINA trial

Pfizer (PFE) and Alliance Foundation Trials announced results from the Phase 3 PATINA trial demonstrating that the addition of Ibrance to current standard-of-care first-line maintenance therapy resulted in statistically significant and clinically meaningful improvement in progression-free survival, or PFS, by investigator assessment in patients with hormone receptor-positive, human epidermal growth factor receptor 2-positive metastatic breast cancer. In the study, which is sponsored by AFT, median PFS was 44.3 months for patients treated with Ibrance in combination with anti-HER2 therapy and endocrine therapy, and 29.1 months for patients treated with anti-HER2 therapy and endocrine therapy alone. This represents an extension in median PFS of over 15 months. Overall survival, a secondary endpoint, was not yet mature at the time of the analysis. These results are being presented during a late-breaking oral session and highlighted in the press program at the 47th San Antonio Breast Cancer Symposium, or SABCS, in San Antonio, Texas. The safety and tolerability of Ibrance in the PATINA study was consistent with its known safety profile in HR+, human epidermal growth factor receptor 2-negative MBC, and no new safety signals were identified. The most common adverse events observed with Ibrance were hematologic toxicities, such as neutropenia and leukopenia. Non-hematologic adverse events included fatigue, stomatitis and diarrhea, which were generally mild to moderate in severity. Since its initial regulatory approval in 2015, Ibrance continues to be a standard-of-care first-line treatment for HR+, HER2- MBC and has been approved in more than 108 countries. Pfizer plans to share the results from PATINA with regulatory authorities.