PFS (Primary Endpoint)    

PALOMA-2 PFS (Primary Endpoint)

In PALOMA-2, PALBACE^® in combination with letrozole delivered >2 years mPFS in first line^1,2 with 37.6 months of clinical trial follow-up.²

PALOMA-2 PFS* Kaplan-Meier Curve¹   

In a randomised (assigned in a 2:1 ratio), double-blind, Phase III trial of postmenopausal women with ER+/HER2- mBC (N=666)¹   

35.7 months of mPFS with PALBACE^® + letrozole (95% CI, 27.7-38.9) versus 19.5 months with placebo + letrozole (95% CI, 16.6-26.6) in a BICR (HR = 0.611; 95% CI, 0.485-0.769)²   

Adapted from Finn RS, et al. 2016¹; Rugo H, et al. 2019.²   

Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the PALBACE^® + LET arm.²   

This benefit was seen across a broad range of women

In an updated non-prespecified subgroup analysis, PALBACE^® in combination with letrozole extended mPFS across the first-line postmenopausal patient subgroups studied versus placebo + letrozole²:

•  Subgroups included:
  • Elderly patients (≥65 years)
  • Patients with visceral disease
  • Patients with bone-only disease

PALOMA-2 Updated Non-prespecified Subgroup Analysis²

Adapted from Rugo H, et al. 2019.²

Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the PALBACE® + LET arm at data cut-off date of 31 May 2017.

*Evaluated according to RECIST version 1.1.^1 
†Data cut-off date: 26 February 2016.^1 
‡Data cut-off date: 31 May 2017.
^§One-sided P-value from the log-rank test.²
^||Per tumour site.²
^¶TFI was defined as the time from the end of (neo)adjuvant therapy to disease progression.²
**A few patients initially enrolled as having measurable disease were later found to have non-measurable disease beyond bone-only disease.²

BICR, blinded independent central review; CI, confidence interval; ECOG PS, Eastern Cooperative Oncology Group performance status; ER+/HER2-, oestrogen receptor-positive/human epidermal growth factor receptor 2-negative; ET, endocrine therapy; HR, hazard ratio; HR+/HER2-, hormone receptor-positive/human epidermal growth factor receptor 2-negative; IA, investigator assessed; LET, letrozole; mBC, metastatic breast cancer; mPFS, median progression-free survival; N, total number of patients; n, number of patients; NE, not estimable; NR, not reached; PFS, progression-free survival; PLA, placebo; RECIST, Response Evaluation Criteria in Solid Tumours; TFI, treatment-free interval.   

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