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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
IBRANCE + fulvestrant in first-line or later treatment demonstrated PFS improvements versus placebo + fulvestrant in patients with visceral metastases, including the lungs and liver*1 In PALOMA-3, 58% of patients treated with IBRANCE + fulvestrant had visceral disease, which included the lungs and liver†1 Small patient numbers can be a limitation of subgroup analysis. These analyses are not intended to demonstrate efficacy in particular subgroups.
Adapted from Turner NC, et al. 2018.1
Data cut-off date: 23 October 2015.
*Evaluated according to RECIST Version 1.1.2
†Visceral disease included liver, lung, pleura, peritoneum and/or brain metastases.2
CI = confidence interval; FUL = fulvestrant; HR = hazard ratio; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3;
PFS = progression-free survival; PLA = placebo; RECIST = Response Evaluation Criteria in Solid Tumors.

References: 1. Turner NC, et al. Ann Oncol. 2018;29(3):669-680. 2. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.IBRANCE + fulvestrant in first-line or later treatment demonstrated PFS improvements versus placebo + fulvestrant in premenopausal patients*1In PALOMA-3, 21% of patients treated with IBRANCE + fulvestrant were pre-/perimenopausal†1
 Adapted from Loibl S, et al. 2016.1
Data cut-off date: 16 March 2015.
*Evaluated according to RECIST Version 1.1.2
†Pre-/perimenopausal patients enrolled in PALOMA-3 received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of the trial.1
CI = confidence interval; FUL = fulvestrant; HR = hazard ratio; LHRH = luteinising hormone-releasing hormone; NE = not estimable; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3;  PFS = progression-free survival; PLA = placebo; RECIST = Response Evaluation Criteria in Solid Tumors.

References: 1. Loibl S, et al. Oncologist. 2017;22(9):1028-1038. 2. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.In a post hoc subgroup analysis, IBRANCE + fulvestrant in first-line or later treatment demonstrated PFS improvements versus placebo + fulvestrant in elderly patients*1In PALOMA-3, 24.8% of patients treated with IBRANCE + fulvestrant were aged ≥65 years1 Adapted from Rugo HS, et al. 2018.1
Data cut-off date: 23 October 2015.
*Evaluated according to RECIST Version 1.1.2
CI = confidence interval; FUL = fulvestrant; HR = hazard ratio; NE = not estimable; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3;  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. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.In an exploratory, post hoc analysis of PALOMA-2, first-line IBRANCE + letrozole delayed median time to chemotherapy by 10.5 months versus placebo + letrozole*1 Adapted from Rugo HS, et al. 2019.1
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.1
AE = adverse event; 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.

References: 1. Rugo HS, et al. Breast Cancer Res Treat. 2019;174(3):719-729. 2. Brufsky A. Clin Med Insights Oncol. 2015;9:137-147.Patients were able to receive ET and chemotherapy as further treatment options following progression on IBRANCE + letrozole1,2First Subsequent Systemic Anticancer Therapies After Permanent Study Treatment Discontinuation2 Adapted from Rugo HS, et al. 2019.2
Data cut-off date: 31 May 2017.
*Percentages are calculated using ‘n’ as a denominator.2
AI = aromatase inhibitor; CDK = cyclin-dependent kinase; ET = endocrine therapy; LET = letrozole; mTOR = mechanistic target of rapamycin; PLA = placebo.

References: 1. Rugo HS, et al. Breast Cancer Res Treat. 2019;174(3):719-729. 2. Rugo HS, et al. Breast Cancer Res Treat. 2019;174(3):719-729. Supplementary Appendix.In an exploratory, post hoc analysis of PALOMA-3, IBRANCE + fulvestrant in first-line or later treatment delayed median time to chemotherapy by 8.8 months versus placebo + fulvestrant1 Adapted from Turner NC, et al. 2018.2
Data cut-off date: 13 April 2018.
AE = adverse event; CI = confidence interval; FUL = fulvestrant; HR = hazard ratio; PALOMA-3 = the palbociclib ongoing trials in the management of breast cancer 3;  PLA = placebo; TCT = time to chemotherapy.

References: 1. Turner NC, et al. N Engl J Med. 2018;379(20):1926-1936. 2. Turner NC, et al. N Engl J Med. 2018;379(20):1926-1936. Supplementary Appendix. 3. Brufsky A. Clin Med Insights Oncol. 2015;9:137-147.Patients were able to receive ET and chemotherapy as further treatment options following progression on IBRANCE + fulvestrant1Systemic Anticancer Therapies Received as First-line or Later Treatment by >10% of the Patients in Either Trial Group That Discontinued the Intervention1 Adapted from Turner NC, et al. 2018.1
*Percentages calculated using the number of patients in the ITT population who received any treatment after study drug discontinuation.
†One subject with missing/partial start/stop dates for reported follow-up therapies is not included.
‡In the fulvestrant arm, 27 patients received post-progression CDK4/6 inhibitors: 3 received ribociclib; 22 received IBRANCE only (2 received IBRANCE twice plus different ETs (24 counts); and 2 received IBRANCE and
subsequent abemaciclib (4 counts).1
CDK = cyclin-dependent kinase; ET = endocrine therapy; FUL = fulvestrant; ITT = intention-to-treat; mTOR = mechanistic target of rapamycin; PLA = placebo.



Reference: 1. Turner NC, et al. N Engl J Med. 2018;379(20):1926-1936.

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

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