Healthcare giant Pfizer’s IBRANCE (palbociclib) as a combination therapy has improved progression-free survival from a Phase III trial in patients with metastatic breast cancer.
Unveiled alongside Alliance Foundation Trials as part of the 47th San Antonio Breast Cancer Symposium (SABCS), results from the Phase III PATINA trial (NCT02947685) found that patients treated with IBRANCE, in combination with anti-HER2 therapies such as trastuzumab or trastuzumab plus pertuzumab, saw their medical profession free survival extended by an additional 15 months. The data for the secondary endpoint of overall survival is not yet mature.
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Hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-positive (HER2+) metastatic breast cancer have been an area of intense focus for the oncology industry with research by the National Cancer Institute finding that the cancer type comprised 10% of all breast cancers.
Known as a CDK4/6 inhibitor, Pfizer claims that IBRANCE, initially approved in 2015, is the first treatment of its kind to show a benefit in first-line HR+, HER2+ metastatic breast cancer, in combination with anti-HER2 and endocrine therapy. Other CDK4/6 inhibitors on the market for breast cancer include Eli Lilly’s Verzenio (abemaciclib), which was approved in March 2023, and Novartis’s Kisqali (ribociclib) which was approved in March 2017.
Roger Dansey, chief development officer of oncology at Pfizer, said: “IBRANCE, the first CDK4/6 inhibitor, revolutionised the treatment of HR-positive, HER2-negative metastatic breast cancer, and has been prescribed to over 773,000 patients since its initial approval in 2015.
“These results demonstrate that the addition of IBRANCE to the standard of care shows promise as maintenance therapy in HR-positive, HER2-positive disease. PATINA underscores Pfizer’s ongoing commitment to addressing the unmet needs of people with breast cancer, and we look forward to discussing the results with regulatory authorities.”
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By GlobalDataAlongside the mixed early results, the company said that the safety and tolerability of IBRANCE in the PATINA study was consistent with its known safety profile, with some adverse events (AEs) including hematologic toxicities, such as neutropenia and leukopenia. Non-hematologic adverse events included fatigue, stomatitis and diarrhoea.
Otto Metzger, principal investigator for Alliance Foundation Trials, said: “PATINA is the first large Phase III study to show the benefit of CDK4/6 inhibition in HR-positive, HER2-positive metastatic breast cancer. These results support the potential of this maintenance treatment to slow disease progression and improve clinical outcomes in this patient population.”
The news follows after Arvinas and Pfizer shared additional preliminary outcomes from the Phase Ib segment of the TACTIVE-U sub-trial of vepdegestrant plus Verzenio in the same indication. Elsewhere in the field of breast cancer, Eli Lilly has released results from its Phase III EMBER-3 trial showing that imlunestrant can cut the risk of disease progression or death by 38%.
