Ibrance is indicated for the treatment of patients with hormone receptor positive, human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine-based therapy; or fulvestrant in patients with disease progression following endocrine therapy.1

Clinical efficacy across patient groups

All subgroups studied​​​​​​​ Visceral disease Bone-only disease Elderly Pre-/peri-menopausal
In 1st line with letrozole
In an updated non-prespecified PFS analysis of PALOMA-2, 1st line IBRANCE + letrozole demonstrated PFS improvements vs placebo + letrozole in patients with bone-only disease*†2
  • In PALOMA-2, 23.2% of patients treated with IBRANCE + letrozole had bone-only disease2

Small patient numbers can be a limitation of subgroup analyses. These analyses are not intended to demonstrate efficacy in particular subgroups.

Adapted from Rugo H, et al. 2019.2
Data cut-off date: May 31, 2017.

In the same PFS analysis:

30.4 months mPFS with IBRANCE + letrozole vs 16.5 months with placebo + letrozole (HR=0.51) in patients with a single disease site, who, together with bone-only patients, are considered patients with low disease burden*†2​​​​​​

*Evaluated according to RECIST Version 1.1.3 Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the IBRANCE + letrozole arm.2
CI = confidence interval; FUL = fulvestrant; HR = hazard ratio; LET = letrozole; n = number of patients; PFS = progression-free survival; PLA = placebo; RECIST = Response Evaluation Criteria in Solid Tumors.

References
  1. IBRANCE® (Palbociclib) Prescribing Information. Available from: http://labeling.pfizer.com/ShowLabeling.aspx?id=12240. Accessed September 17, 2021.
  2. Rugo H, et al. Breast Cancer Res Treat. 2019;174(3):719-729.
  3. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.

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All rights reserved. Date of preparation: June 2020 PP-IBR-GLB-0254

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