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Clinical Efficacy & SafetyPALOMA-2Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)PALOMA-3Trial Design OverviewPatient Baseline CharacteristicsPFS (Primary Endpoint)OS (Secondary Endpoint)Tumour Control (Secondary Endpoint)SafetySafety OverviewPooled ARsPooled Laboratory AbnormalitiesPALOMA-2 AEsPALOMA-3 AEsSelected Safety FeaturesPALBACE® Long-term SafetyGI and Liver ToxicitiesEffect of PALBACE®  on QTc IntervalElderly PatientsVisceral Disease PatientsDose Reduction Effect on EfficacyReal-world EvidenceWhat are RWD and RWE?PALBACE® Development and RWDHow Does RWE Differ From RCT Evidence?What Is Meant by RWD and RWE?What Is the Value of RWE?Multiple Ongoing Real-world Studies at Varied Geographic LocationsEffectivenessWhat is the Flatiron Database?What Were the Key Features of P-REALITY?What Are the Characteristics of Patients in P-REALITY?P-REALITY Real-world Progression-free SurvivalP-REALITY Overall SurvivallP-REALITY StrengthsP-REALITY SummaryTolerability/QoLWhat is the MADELINE Study?What Were the Key Features of the MADELINE Study?What Are the Characteristics Of Patients In MADELINE?MADELINE Physician-reported AEsMADELINE Patient-reported OutcomesMADELINE Study LimitationsMADELINE SummaryDosingDosingRecommended Dosing ScheduleRecommended Dose Modifications For AEsMonitoring

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OS (Secondary Endpoint)

At the time of final analysis of PFS in the PALOMA-2 trial, final OS analysis was performed after required events were reached (Nov 2021) with median follow-up of 90 months.1

    

Statistical Assumptions for OS as Secondary endpoint1:

  • Assumption for the control arm median OS of 34 to 46 months (~35% improvement)
     
  • PALOMA-2 is an event-driven trial, in which an estimated 390 events of death are required to to detect a hazard ratio of 0.74 or less (80% power with 1-sided α=0.025), if differences in OS reach a level of significance

Overall Survival (ITT) Secondary endpoint

   

Median OS (95% CI) was 53.9 months (49.8–60.8) in the PAL+LET arm and 51.2 months (43.7 –58.9) in the PBO+LET arm (hazard ratio, 0.956 [95% CI, 0.777–1.177]; stratified 1-sided P=0.3378)2

    

    

Overall Survival in Subgroups (ITT Population)*: Prespecified analysis

    

In this OS analysis, a proportion of pts were not available for follow-up (withdrew consent or lost to follow-up) and were censored: 21% in the PBO+LET arm versus 13% in the PAL+LET arm2

    

    

     

Adapted from Finn RS, et al. Abstract LBA1003. ASCO 2022.
Data cutoff: November 15, 2021.

    

OS Excluding Patients with Survival Data Not Available: Post-hoc sensitivity analysis

   

A posthoc sensitivity analysis excluding these pts resulted in a median OS (95% CI) of 51.6 months (46.9–57.1) with PAL+LET and 44.6 months (37.0–52.3) with PBO+LET (hazard ratio, 0.869 [95% CI, 0.706–1.069])2

   

   

OS was numerically longer in the PAL+LET arm vs the PBO+LET arm, but the results were not statistically significant1

  • Median survival of over 50 months in this population represents a significant improvement in the natural history of HR+ breast cancer
     
  • This is highlighted in the subgroups of patients with DFI >12 months (median OS of 66 months)
     
  • 10% of patients continue on PAL+LET vs 2% of patients on PBO+LET in the study after 7.5 years of follow-up

   

*Small patient numbers can be a limitation of such analyses. These analyses may not be powered to detect significant differences and were not designed to compare across subgroups. Any comparison between groups should be approached with caution.

   

CI, confidence interval; DFI, disease-free interval; ECOG, Eastern Cooperative Oncology Group; ITT, intention to treat; LET, letrozole; OS, overall survival; PAL, palbociclib; PALOMA, PALbociclib: Ongoing trials in the Management of breast cAncer; PBO, placebo; PFS, progression-free survival; Pts, patients.

   

References:

Finn RS, Rugo HS, Dieras VC, Veronique C, et al. PALOMA-2: Overall Survival With First-Line PAL+LET vs PBO+LET in Women With ER+/HER2- aBC. Oral presentation at: American Society of Clinical Oncology Annual Meeting 2022; June 3–7, 2022.

Finn RS, Rugo HS, Dieras VC, Veronique C, et al. Overall survival (OS) with first-line palbociclib plus letrozole (PAL+LET) versus placebo plus letrozole (PBO+LET) in women with estrogen receptor–positive/human epidermal growth factor receptor 2–negative advanced breast cancer (ER+/HER2− ABC): Analyses from PALOMA-2. J Clin Oncol. 2022; 40(17):LBA1003-LBA1003.

   

Please click the Prescribing Information link to view the safety and adverse events information of PALBACE®.
For the use only of Registered Medical Practitioners or a Hospital or a Laboratory.

    

PP-IBR-IND-0462 27 July 2022

PALOMA-2

Real-world Evidence

With RCT data, PALBACE® RWE can help improve the understanding of outcomes in patients with HR+/HER2- mBC

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Recommended dosing schedule and dose modifications for AEs

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