Overall survival results from phase III PALOMA-2 trial of Ibrance for the first-line treatment of ER+, HER2- metastatic breast cancer.- Pfizer
Pfizer Inc. announced overall survival (OS) results from the Phase III PALOMA-2 trial, which evaluated Ibrance (palbociclib) in combination with letrozole compared to placebo plus letrozole for the first-line treatment of postmenopausal women with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer (mBC).
With a median follow-up of 90 months, patients receiving Ibrance in combination with letrozole had numerically longer OS compared to placebo plus letrozole (median (95% CI) 53.9 months (49.8–60.8) vs median 51.2 months (43.7–58.9)); the results were not statistically significant (Hazard Ratio (HR)=0.956 [95% CI, 0.777–1.177]). The PALOMA-2 trial was designed for a primary endpoint of progression-free survival (PFS) with OS as one of the secondary endpoints. The results were presented as an oral presentation at the American Society of Clinical Oncology (ASCO) 2022 Annual Meeting (LBA 1003).
"Ibrance continues to provide substantial benefit as a first-line treatment for adults with HR+, HER2- mBC based on strong progression-free survival data, which formed the basis of its worldwide approvals,” said Chris Boshoff, M.D., Ph.D., Chief Development Officer, Oncology, Pfizer Global Product Development. “Interpretation of OS in PALOMA-2 is limited by the large and disproportionate censoring of patients with missing survival data between treatment arms. We remain confident in the compelling benefits that Ibrance plus endocrine therapy offers to this patient population, which is underscored by data from PALOMA-2 showing delayed time to chemotherapy, maintenance of quality of life and a consistent safety profile. Pfizer continues to invest in expanding the treatment options for people living with metastatic breast cancer.”
PALOMA-2 met its primary endpoint of PFS in 2016 and was published in The New England Journal of Medicine in November 2016. The results demonstrated Ibrance plus letrozole resulted in an improved median PFS of 24.8 months when compared to 14.5 months with placebo plus letrozole (HR=0.580). The PALOMA-2 trial showed that in addition to substantially delaying progressive disease, Ibrance as first-line treatment, in combination with letrozole, delayed time to chemotherapy (38.1 months vs 29.8 months; HR, 0.73), while maintaining quality of life with no new identified safety issues..
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