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The content of this website has been produced in line with the IBRANCE® Summary of Product Characteristics. IBRANCE® (palbociclib) Prescribing Information for the UK click here. Adverse event reporting information can be found at the bottom of the page.
P-VERIFY: The Largest Real-World Comparative Overall Survival Analysis of First-line CDK4/6 Inhibitors + AI in HR+/HER2- mBC to Date
STUDY OBJECTIVE
To compare OS of patients with HR+/HER2- mBC receiving first-line palbociclib, ribociclib or abemaciclib in combination with an Al in US clinical practice.*1
STUDY DESIGN
*Patients still alive were censored at the end of the study.1 †Unadjusted analyses were conducted first, followed by sIPTW for the primary analysis. sIPTW is a statistical technique used in real-world studies to adjust for key baseline variables;2. While sIPTW and multivariable analyses were used to balance baseline characteristics, unmeasured confounders cannot be addressed through these methods. Sensitivity analyses included multivariable analyses, 1:1 exact matching and a sub-analysis for patients who started index treatment in 2017 or later;1 ‡Patients were followed from start of index treatment to data cut-off, death or last medical activity, whichever came first.1
*Except for insurance type;1 †Multiple metastases at the same site were counted as one site (e.g., three bone metastases in the spine were considered only one site);1 ‡Visceral disease is defined as metastatic disease in the lung and/or liver; patients could have had other sites of metastases;3 §Bone-only disease is defined as metastatic disease in the bone only.1
*OS was a secondary endpoint in all three pivotal first-line CDK4/6 inhibitor RCTs in HR+/HER2- mBC. Palbociclib + letrozole did not show a statistically significant OS difference in PALOMA-2.1,6 Abemaciclib + AI did not show statistically significant OS difference in MONARCH-3.7 Ribociclib + letrozole demonstrated a statistically significant OS difference in MONALEESA-2;8 †OS was defined as the number of months from start of index treatment to death. Patients still alive were censored at the study cut-off date (31 May 2024);1 ‡Median duration of follow-up in the palbociclib, ribociclib and abemaciclib groups was 33 months, 15.7 months and 21.5 months, respectively, with 45.3%, 25.6% and 28% of deaths observed, respectively.1
P-VERIFY, palbociclib verifying evidence of real world impact study; Al, aromatase inhibitor; CDK4/6, cyclin-dependent kinase 4/6; Cl, confidence interval; HER2-, human epidermal growth factor receptor 2 negative; HR+, hormone receptor positive; mBC, metastatic breast cancer; OS, overall survival; slPTW, stabilised inverse probability treatment weighting; ECOG PS, Eastern Cooperative Oncology Group performance status; OS, overall survival; RCT, randomised controlled trial
References
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PP-UNP-GBR-13971. December 2025