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Monitoring
Summary of Prescibing Information
Median OS (primary endpoint) was longer among patients who received PALBACE® + AI vs AI alone before adjustment (HR=0.67; p<0.0001) and after sIPTW (HR=0.76; p<0.0001) and PSM adjustment (HR=0.72; p<0.0001)1
Adapted from Rugo H, et al. 2022.1
* OS was defined as the time in months from the start of study treatment until death.¹
PALBACE® + AI was associated with a significantly prolonged median OS vs AI alone, resulting in a 24% reduction in risk of death (in sIPTW analysis); HR=0.76 (95% CI: 0.65–0.87; p<0.0001)1
PALOMA-2 did not meet the secondary endpoint of OS (prespecified HR≤0.74)1
Median rwPFS (secondary endpoint) was significantly longer among patients who received PALBACE® + AI vs AI alone before (HR=0.68; p<0.0001) and after sIPTW (HR=0.70; p<0.0001) and PSM adjustment (HR=0.72; p<0.0001)
Adapted from Rugo H, et al. 2022.1
* rwPFS was defined as the number of months from the start of treatment with PALBACE® + AI or AI alone to the
date of the first documentation of disease progression by the treating clinician based on radiology,
laboratory evidence, pathology, or clinical assessment or death due to any cause, whichever occurred first.
PALBACE® + AI was associated with a significantly prolonged median rwPFS vs AI alone, resulting in a 30% reduction in risk of real-world disease progression (in sIPTW analysis); HR=0.70 (95% CI: 0.62–0.78; p<0.0001)1
AI = aromatase inhibitor; CI = confidence interval; HR = hazard ratio; N/n = number of patients; PFS = progression-free survival; PSM = propensity score matching; rwPFS = real-world progression-free survival; sIPTW = stabilized inverse probability treatment weighting.
References:
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PP-IBR-IND-0626 September 2023
Impact of PALBACE® in combination with another drug on patients’ QoL
PALOMA was the first clinical trial programme to explore how a CDK4/6 inhibitor could benefit women with HR+/HER2- mBC
Recommended dosing schedule and dose modifications for AEs
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