Clinical efficacy across patient groups

 

IBRANCE® has included a broad range of patients with HR+/HER2- mBC in its clinical trials2,3

clinical-efficacy-across-patient-groups
 

*Pre-/peri-menopausal patients enrolled in PALOMA-3 received the LHRH agonist goserelin for at least 4 weeks prior to and for the duration of the trial.3  In PALOMA-2, 40.1% of IBRANCE®-treated patients had a disease-free interval of >12 months and 22.3% had a disease-free interval of ≤12 months (defined as time from adjuvant or neoadjuvant therapy to recurrence).2 Patients who received a non-steroidal aromatase inhibitor (i.e., anastrozole or letrozole) as a component of their prior 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.2,4  Patients were defined as sensitive to prior ET if they had a relapse after 24 months of adjuvant ET or had a clinical benefit (objective response [complete or partial] or stable disease lasting ≥24 weeks) from prior ET in the context of advanced disease.5 #Those that are not ET sensitive. §Newly metastatic disease applies to patients who had not received any prior systemic therapy, for whom a determination of disease-free interval was not possible.1 ¶Patients with known active uncontrolled or symptomatic CNS metastases were excluded.2,3

In 1st line with letrozole
In an updated non-prespecified subgroup analysis of PALOMA-2, IBRANCE® + letrozole consistently extended mPFS across the 1st line post-menopausal patient subgroups studied vs placebo + letrozole6

clinical-efficacy-across-patient-groups
 

Adapted from Rugo H, et al. 2019.6
Updated follow-up of the primary analysis of PALOMA-2: 37.6 months in the IBRANCE® + LET arm at data cut-off date of May 31, 2017.
*1-sided P-value from the log-rank test.6 †Per tumour site.TFI was defined as the time from the end of (neo)adjuvant therapy to disease progression.#A few patients initially enrolled as having measurable disease were later found to have non-measurable disease beyond bone-only disease.6
 

In 1st or later line with fulvestrant

IBRANCE® + fulvestrant in 1st line or later reduced the risk of disease progression vs placebo + fulvestrant in pre-/peri-/post-menopausal women4

clinical-efficacy-across-patient-groups

 
 

Adapted from IBRANCE® EPAR Public assessment report.4
Data cut-off: 23 October 2015.
*Visceral metastasis was defined as lung, liver, brain, pleural, or peritoneal involvement.3  Sensitivity to prior hormonal therapy is defined as either a) documented clinical benefit (i.e. complete response, partial response or stable disease ≥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.Disease-free interval is time from diagnosis of primary breast cancer to first relapse in patients who received adjuvant therapy.4 §Aromatase inhibitor = anastrazole, letrozole or exemestane. #Anti-oestrogen = tamoxifen, tamoxifen citrate, toremifene, or toremifene citrate. Other = neither an aromatase inhibitor nor an anti-estrogen.

AI = aromatase inhibitor; BICR = blinded independent central review; CI = confidence interval; CNS = central nervous system; ECOG = Eastern Cooperative Oncology Group; ET = endocrine therapy; FUL = fulvestrant; HR+/HER2- = hormone receptor-positive, human epidermal growth factor receptor 2-negative; HR = hazard ratio; IA = investigator assessed; ITT = intention to treat; LET = letrozole; LHRH = luteinising hormone-releasing hormone; mBC = metastatic breast cancer; mPFS = median progression-free survival; N/n = number of patients; NE = not estimable; PLA = placebo; RECIST = Response Evaluation Criteria in Solid Tumors; TFI = treatment-free interval.
 
 
References  
  1. IBRANCE® Summary of Product Characteristics.
  2. Finn RS, et al. N Engl J Med. 2016;375(20):1925-1936.
  3. Cristofanilli M, et al. Lancet Oncol. 2016;17(4):425-439.
  4. IBRANCE® EPAR Public assessment report. 25 Nov 2016. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_Public_assessment_report/human/003853/WC500217198.pdfAccessed July 2019.
  5. Turner NC, et al. N Engl J Med. 2018;379(20):1926-1936.
  6. Rugo H, et al. Breast Cancer Res Treat. 2019;174(3):719-729.

PP-IBR-IRL-0373 Date of Preparation January 2020