Paloma-2 Study design

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PALOMA-2 Study Design

A randomised, double-blind, placebo-controlled, Phase III efficacy study to assess the safety and efficacy of IBRANCE in combination with letrozole as first-line treatment of postmenopausal women with ER+/HER2- ABC¹

Adapted from Finn RS, et al. 2016.¹
*Evaluated according to RECIST Version 1.1.¹
†ORR was defined as confirmed CR or PR.¹
‡CBR was defined as confirmed CR, PR or SD for ≥24 weeks.¹
ABC = advanced breast cancer; CBR= Clinical benefit response; CR= complete response; DOR= duration of response; DFI = disease-free interval; ER+= oestrogen receptor-positive; HER2-= human epidermal growth factor receptor 2-negative;
ORR= overall response rate; OS= overall survival; PALOMA-2= letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PFS = progression-free survival; PR= partial response; QTc = QT interval corrected for heart rate; RECIST= Response Evaluation Criteria in Solid Tumours; SD= stable disease.
Reference: 1. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.

PALOMA-2 Baseline Characteristics

Adapted from Finn RS, et al. 2016.¹
Data cut-off date: 26 February 2016. Some percentages do not sum to 100 because of rounding off.
*DFI was defined as the time from adjuvant or neoadjuvant therapy to recurrence. Newly metastatic disease applies to patients who had not received any prior systemic therapy, for whom a determination of DFI was not possible.¹
†Patients who received anastrozole or letrozole as a component of their adjuvant or neoadjuvant therapy were excluded from the study if they had disease progression while receiving the therapy or within 12 months after completing the therapy.¹

DFI= disease-free interval; ECOG= Eastern Cooperative Oncology Group; LET= letrozole; PLA= placebo.

Reference: 1. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.

IBRANCE in combination with letrozole delivered >2 years mPFS in first-line treatment in the PALOMA-2 trial_,1,2 with 37 months of clinical trial follow-up^*2

Adapted from Finn RS, et al. 2016¹; Rugo H, et al. 2019.²
*Evaluated according to RECIST Version 1.1.¹
†Data cut-off date: 26 February 2016.¹
‡Data cut-off date: 31 May 2017. Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the IBRANCE + LET arm.²

CI = confidence interval; ER+= oestrogen receptor-positive; HER2- = human epidermal growth factor receptor 2-negative; HR = hazard ratio; LET = letrozole; mBC = metastatic breast cancer; mPFS = median progression-free survival; NE = not estimable;
OS = overall survival; PALOMA-2: letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PFS = progression-free survival; PLA = placebo; RECIST = Response Evaluation Criteria in Solid Tumors.

References: 1. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936. 2. Rugo HS, et al. Breast Cancer Res Treat. 2019;174(3):719-729.

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