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Pfizer Presents Overall Survival Data From PALOMA-3 Trial of IBRANCE® (palbociclib) in Patients With HR+, HER2- Metastatic Breast Cancer

Pfizer Inc.(NYSE:PFE) today announced detailed overall survival (OS)
data from the PALOMA-3 trial, which evaluated IBRANCEA® (palbociclib) in
combination with fulvestrant compared to placebo plus fulvestrant in
women with hormone receptor-positive (HR+), human epidermal growth
factor receptor 2-negative (HER2-) metastatic breast cancer whose
disease progressed on or after prior endocrine therapy. In the study,
there was a numerical improvement in OS of nearly seven months with
IBRANCE plus fulvestrant compared to placebo plus fulvestrant, although
this difference did not reach the prespecified threshold for statistical
significance (median OS: 34.9 months [95% CI: 28.8, 40.0] versus 28.0
months [95% CI: 23.6, 34.6]; HR=0.81 [95% CI: 0.64, 1.03], 1-sided
p=0.0429). These data will be presented as a late-breaking oral abstract
during the Presidential Symposium at the ESMO 2018 Congress (European
Society for Medical Oncology) in Munich, Germany, and simultaneously
published in The New England Journal of Medicine.


The difference in median OS demonstrated in this analysis (6.9 months)
is consistent with the improvement previously demonstrated for the
primary endpoint of median progression-free survival (mPFS). In the
updated PFS analysis for this study (non-prespecified), the combination
of IBRANCE plus fulvestrant showed a statistically significant and
clinically meaningful 6.6-month mPFS improvement compared to placebo
plus fulvestrant (11.2 vs. 4.6 months; HR=0.50 [95% CI: 0.40-0.62],
p<0.000001).1 Overall survival is a secondary endpoint of
PALOMA-3, and the trial design was not optimized to detect a
statistically significant difference in OS.


"Ita??s noteworthy that the magnitude of progression-free survival benefit
observed in PALOMA-3 has translated to a similar difference of nearly
seven months in overall survival, which is clinically meaningful. This
is particularly significant given the challenges of demonstrating
overall survival in this disease setting, where post-progression therapy
is often substantially longer than time on study,a?? said Massimo
Cristofanilli, M.D., associate director for Translational Research at
the Robert H. Lurie Comprehensive Cancer Center of Northwestern
University, as well as senior investigator of the PALOMA-3 trial. "The
overall survival data, coupled with the previously demonstrated
progression-free survival benefit, are encouraging for patients.a??


At the time of this analysis, follow-up was 44.8 months and
approximately 60 percent (n=310) of events had occurred in the 521
patients enrolled. Patients on both arms received up to 10 lines (range
1-10) of post-progression treatment.
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