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MOA MOA MOA EfficacyEfficacyPALOMA-2 Study designPatient Characteristics Primary endpoint Secondary end point PALOMA-3Study design Patient Characteristics Primary endpoint Secondary end point SurvivalFinal analysis Subgroup analysis Prespecified groups Updated Subgroup analysis Safety Safety PALOMA pooled analysis Adverse reactions  & Laboratory abnormalities PALOMA 2 Adverse Events PALOMA 3 Adverse Events IBRANCE consistent  safety profile Pooled analysis of patients aged ≥65 years in the PALOMA trials No evidence of cumulative or delayed toxicity with up to 50 months Patients with visceral diseases GI ,  Liver toxicities, and QTC Dosing Dosing Once daily dosing Dose Modification Real-World EvidenceReal-world EvidenceIBRANCE is the only CDK4/6 inhibitor with >5 years of real-world experience Real-world data provide additional information Favorable progression free rates IRIS Study In the real world, IBRANCE benefits GuidelinesGuidelinesNCCN Guidelines ESMO Guidelines Support & Services Support & Resources Patient support program/tools Events Materials Videos
Ibrance®  US Prescribing Information  Click Here
In an updated, non-prespecified subgroup analysis, IBRANCE + letrozole extended mPFS across the first-line post-menopausal patient subgroups studied versus placebo + letrozole1
​​​​​​ Adapted from Rugo HS, et al. 2019.1
Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the IBRANCE + LET arm at data cut-off date of 31 May 2017.
*One-sided P-value from the log-rank test.1
†Per tumour site.1
‡TFI was defined as the time from the end of (neo)adjuvant therapy to disease progression.1
§A few patients initially enrolled as having a measurable disease were later found to be having a non-measurable disease beyond bone-only disease.1
BICR = blinded independent central review; CI = confidence interval; ECOG = Eastern Cooperative Oncology Group; ET = endocrine therapy; HR = hazard ratio; IA = investigator assessed; LET = letrozole; mPFS = median  progression-free survival; NE = not estimable; PALOMA-2= letrozole for 1st line treatment of postmenopausal women with ER+/HER2- advanced breast cancer; PLA = placebo; TFI = treatment-free interval.

Reference: 1. Rugo HS, et al. Breast Cancer Res Treat. 2019;174(3):719-729.In an updated, non-prespecified PFS analysis, first-line IBRANCE + letrozole demonstrated PFS improvements versus placebo + letrozole in patients with visceral metastases, including the lungs and liver*†1In PALOMA-2, 48.2% of patients treated with IBRANCE + letrozole had visceral disease, which included the lungs and liver2 Adapted from Rugo HS, et al. 2019;1 Ibrance. Data on file.3
Data cut-off date: 31 May 2017.
*Evaluated according to RECIST Version 1.1.2
†Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the IBRANCE + letrozole arm.1
CI = confidence interval; HR = hazard ratio; LET = letrozole; 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. Rugo HS, et al. Breast Cancer Res Treat. 2019;174(3):719-729. 2. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936. 3. Ibrance. Data on file.In an updated, non-prespecified PFS analysis, first-line IBRANCE + letrozole demonstrated PFS improvements versus placebo + letrozole in patients with bone-only disease*†1In PALOMA-2, 23.2% of patients treated with IBRANCE + letrozole had bone-only disease1 Adapted from Rugo HS, et al. 2019.1
Data cut-off date: 31 May 2017.
*Evaluated according to RECIST Version 1.1.2
†Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the IBRANCE + letrozole arm.1
CI = confidence interval; HR = hazard ratio; LET = letrozole; mPFS = median progression-free survival; NE = not estimable; 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. Rugo HS, et al. Breast Cancer Res Treat. 2019;174(3):719-729. 2. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.In a post hoc pooled PFS analysis, IBRANCE + letrozole demonstrated PFS improvements versus placebo + letrozole in elderly patients*144% and 40.8% of patients treated with IBRANCE + letrozole were aged ≥65 years in PALOMA-1† and PALOMA-2, respectively2,3 Adapted from Rugo HS, et al. 2018.1
Data cut off dates: 29 November 2013 for PALOMA-1 and 26 February 2016 for PALOMA-2.
*Evaluated according to RECIST Version 1.1.2,3
†PALOMA-1 was an open-label, randomised, Phase II study to assess the safety and efficacy of IBRANCE in combination with letrozole as first-line treatment of patients with ER+/HER2- ABC. The study design of PALOMA-1 is similar to that of PALOMA-2 (PALOMA-2 was double-blind).2

ABC = advanced breast cancer; CI = confidence interval; ER+ = oestrogen receptor-positive; HER2- = human epidermal growth factor receptor 2-negative; HR = hazard ratio; LET = letrozole; NE = not estimable; NR = not reached; PALOMA-1 = Palbociclib: ongoing trials in the management of breast cancer; 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. Rugo HS, et al. Eur J Cancer. 2018;101:123-133. 2. Finn RS, et al. Lancet Oncol. 2015;16(1):25-35. 3. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.IBRANCE + fulvestrant in first-line or later treatment reduced the risk of disease progression versus placebo + fulvestrant in pre-/peri-/postmenopausal women1 Adapted from  Turner 2015 NEJM.2
Data cut-off date: 23 October 2015.
*Visceral metastasis was defined as lung, liver, brain, pleural or peritoneal involvement.2
†Sensitivity to prior hormonal therapy is defined as either (a) documented clinical benefit (i.e. CR, PR or SD ≥24 weeks) to at least 1 prior hormonal therapy in the metastatic setting or (b) at least 24 months of adjuvant hormonal therapy prior to recurrence.1
‡DFI is time from diagnosis of primary breast cancer to first relapse in patients who received adjuvant therapy.1
CI = confidence interval; CR: complete response; DFI: disease-free interval; ECOG = Eastern Oncology Cooperative Group; ER = oestrogen receptor; FUL = fulvestrant; HR = hazard ratio; ITT = intention-to-treat; PgR = progesterone receptor; PLA = placebo; PR = partial response.

References: 1. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439. 2 Turner NC, Huang Bartlett C, Cristofanilli M. Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer. N Engl J Med. 2015 Oct 22;373(17):1672-3.

Prescribing Information: Master GULF LEVANT-LPD- (Ibrance)- Capsules- 75 mg, 100 mg &125 mg based on USPI Revision date: December 2022 – United Arab Emirates

PP-IBR-ARE-0144

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