On Thursday, Pfizer Inc. PFE and Alliance Foundation Trials, LLC (AFT) announced results from the Phase 3 PATINA trial.
The trial demonstrated that the addition of IBRANCE (palbociclib) to current standard-of-care first-line maintenance therapy (following induction chemotherapy) resulted in statistically significant and clinically meaningful improvement in progression-free survival (PFS) in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer.
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In the study, median PFS was 44.3 months for patients treated with IBRANCE in combination with anti-HER2 therapy (trastuzumab or trastuzumab plus pertuzumab) 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.
The safety and tolerability of IBRANCE in the PATINA study were consistent with its known safety profile in HR+, human epidermal growth factor receptor 2-negative (HER2-) 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 remains a standard-of-care first-line treatment for HR+, HER2- MBC and has been approved in more than 108 countries.
In 2023, Ibrance generated sales of $4.75 billion.
Price Action: PFE stock is up 0.24% at $25.29 at the last check on Thursday.
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