THIS SITE IS INTENDED FOR U.S. AUDIENCES ONLY.

THE MPACT STUDY INCLUDED
PATIENTS TYPICALLY SEEN IN REAL-WORLD PRACTICE1,2

ABRAXANE + gemcitabine vs gemcitabine study design for metastatic pancreatic cancer ABRAXANE + gemcitabine vs gemcitabine study design for metastatic pancreatic cancer
The MPACT Study for ARBAXANE + gemcitabine vs. gemcitabine included patients with a broad range of performance status (KPS 70-100) The MPACT Study for ARBAXANE + gemcitabine vs. gemcitabine included patients with a broad range of performance status (KPS 70-100)
There was no upper age limit in the Metastatic Pancreatic Cancer Trial (Age Range: 27-86) There was no upper age limit in the Metastatic Pancreatic Cancer Trial (Age Range: 27-86)
The MPACT Study was conducted in real-world treatment setting The MPACT Study was conducted in real-world treatment setting
Tumor burden1
  • 46% with ≥3 metastatic sites
  • 85% with liver metastases
  • KPS=Karnofsky Performance Status Scale; MPACT=Metastatic Pancreatic Adenocarcinoma Clinical Trial; PS=performance status.
  • Conversion: KPS to ECOG PS

    UNDERSTANDING THE RELATION BETWEEN
    PERFORMANCE STATUS MEASUREMENTS3-5
    UNDERSTANDING THE RELATION BETWEEN PERFORMANCE STATUS MEASUREMENTS3-5

    Conversion of Karnofsky Performance Status (KPS) to Eastern Cooperative Oncology Group Performance Status (ECOG PS) Eastern Cooperative Oncology Group Performance Status (ECOG PS)
    Eastern Cooperative Oncology Group Performance Status (ECOG PS)

    This proposed conversion scale was constructed empirically from a sample of patients (n=1385) with advanced cancer, including different tumor types. Both KPS and ECOG PS were determined by 7 physicians for each patient. This conversion scale had the highest rate of agreement (75%) observed among all possible scales.5

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  • Patients Were Well Balanced Between Treatment Arms

    PATIENTS WERE WELL BALANCED
    BETWEEN TREATMENT ARMS1

    Patient characteristics of the MPACT Study: ABRAXANE + gemcitabine vs gemcitabine Patient characteristics of the MPACT Study: ABRAXANE + gemcitabine vs gemcitabine
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AN ESTABLISHED FIRST-LINE STANDARD OF CARE
WITH A SURVIVAL BENEFIT1,6
AN ESTABLISHED FIRST-LINE STANDARD OF CARE WITH A SURVIVAL BENEFIT1,6

ABRAXANE (125 mg/m2 QW3/4) + gemcitabine significantly increased median OS vs gemcitabine alone ABRAXANE (125 mg/m2 QW3/4)
+ gemcitabine significantly increased
median OS vs gemcitabine alone
Median overall survival: ABRAXANE + gemcitabine vs gemictabine Median overall survival: ABRAXANE + gemcitabine vs gemictabine
  • aStratified using Cox proportional hazard model.
  • bBased on a stratified log-rank test (stratified by geographic region, KPS, and presence of liver metastasis).
  • aStratified using Cox proportional hazard model.
  • bBased on a stratified log-rank test (stratified by geographic region, KPS, and presence of liver metastasis).
  • ORR (Overall Response Rates)

    RESPONSE MATTERS:
    ORR ASSESSED BY INDEPENDENT REVIEW

    ABRAXANE (125 mg/m2 QW3/4) + gemcitabine more than tripled ORR vs gemcitabine alone
    Overall response rates: ABRAXANE + gemcitabine vs gemcitabine Overall response rates: ABRAXANE + gemcitabine vs gemcitabine
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  • PFS (Progression-Free Survival)

    ABRAXANE + GEMCITABINE
    SIGNIFICANTLY IMPROVED PFSa

    49% increase in median PFS with ABRAXANE (125 mg/m2 QW3/4) + gemcitabine
    compared with gemcitabine alone1
    49% increase in median PFS with ABRAXANE (125 mg/m2 QW3/4)
    + gemcitabine compared with gemcitabine alone1
    Progression-free survival: ABRAXANE + gemcitabine vs gemcitabine Progression-free survival: ABRAXANE + gemcitabine vs gemcitabine
    • aBased on independent radiological reviewer assessment.
    • bStratified using Cox proportional hazard model.
    • cBased on a stratified log-rank test (stratified by geographic region, KPS, and presence of liver metastasis).
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PRESPECIFIED KPS SUBGROUPS SHOWED
CONSISTENT SURVIVAL BENEFIT WITH THE ITT POPULATION1,7
PRESPECIFIED KPS SUBGROUPS SHOWED CONSISTENT SURVIVAL BENEFIT WITH THE ITT POPULATION1,7

Median OS was 8.5 vs 6.7 months, respectively; HR 0.72 (95% CI: 0.62-0.83); P<0.0001
Median OS was 8.5 vs 6.7 months, respectively; HR 0.72 (95% CI: 0.62-0.83); P<0.0001
Median OS for KPS 70-80. ABRAXANE + gemcitabine vs gemcitabine
Median OS (95% CI) by KPS subgroups
Median OS for KPS 70-80. ABRAXANE + gemcitabine vs gemcitabine
HR (95% CI) 0.75 (0.62-0.92)
Median OS (95% CI) by KPS subgroups
HR (95% CI) 0.61 (0.48-0.78)
Analysis Limitations: An exploratory analysis should not be interpreted to determine a treatment difference between arms in these selected subgroups because of insufficient sample size and a higher probability of making a false positive finding.
  • Forest Plot of All Prespecified Subgroups

    PRESPECIFIED SUBGROUPS EXPERIENCED
    CONSISTENT SURVIVAL BENEFIT WITH THE ITT POPULATION1
    PRESPECIFIED SUBGROUPS EXPERIENCED CONSISTENT SURVIVAL BENEFIT WITH THE ITT POPULATION1

    Exploratory analysis included subgroups such as age and performance status1
    Forest Plot of all  Prespecified Subgroups for ABRAXANE + gemcitabine vs gemcitabine Forest Plot of all  Prespecified Subgroups for ABRAXANE + gemcitabine vs gemcitabine
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ANNUAL SURVIVAL RATES IN MPACT8 ANNUAL SURVIVAL RATES IN MPACT8

Overall survival prespecified analysis of the MPACT trial Overall survival prespecified analysis of the MPACT trial
Post-Hoc analysis of Long Terms Survivors Data from the MPACT study
aAnalysis Limitations: A post-hoc exploratory analysis should not be interpreted to determine a treatment difference between arms at these selected time points, because of potential selection bias, insufficient sample size, and a higher probability of making a false positive error.
  • bThe initial publication of the MPACT study reported an OS analysis in which 80% of patients had died. This data is from an updated analysis of OS from MPACT with an extended data cutoff (8 months longer) at the time the trial was closed. At that time, 90% of patients in the intent-to-treat (ITT) population had died.8
  • cStratified using Cox proportional hazard model.
  • dBased on a stratified log-rank test (stratified by geographic region, KPS, and presence of liver metastasis).

OS ANALYSIS OF 1L ABRAXANE + GEMCITABINE AND
SUBSEQUENT THERAPY9
OS ANALYSIS OF 1L ABRAXANE
+ GEMCITABINE AND SUBSEQUENT THERAPY9

A post-hoc analysisa of patients who went on to receive subsequent (2L) therapy9
A post hoc analysis of overall survival for patients who went on to receive subsequent therapy after ABRAXANE + gemcitabine A post hoc analysis of overall survival for patients who went on to receive subsequent therapy after ABRAXANE + gemcitabine
aAnalysis Limitations: A post-hoc exploratory analysis should not be interpreted to determine a treatment difference between arms at these selected time points, because of potential selection bias, insufficient sample size, and a higher probability of making a false positive error.
In patients who went on to receive 2L therapy:
  • Median duration of 1L therapy was 5.3 months with ABRAXANE + gemcitabine vs 3.7 months with gemcitabine alone
  • Patients had overall better performance status at baseline and at the end of 1L therapy compared with patients who did not get 2L therapy
  • 2L therapy consisted of 5–FU-based therapy for the majority of patients
Reasons for discontinuing 1L therapy ABRAXANE + gemcitabine vs gemcitabine:
  • Disease progression (59% vs 74%)
  • Adverse reactions (26% vs 14%)

AIM FOR THE RESULTS ACHIEVED IN THE MPACT STUDY:
START PATIENTS AT 125 mg/m2 GIVEN QW3/4

Median overall survival results and Overall Response Rates from the ABRAXANE + gemcitabine Phase III Study Median overall survival results and Overall Response Rates from the ABRAXANE + gemcitabine Phase III Study Median overall survival results and Overall Response Rates from the ABRAXANE + gemcitabine Phase III Study
In the MPACT study1:
  • 41% had at least one ABRAXANE dose reduction
  • 71% had at least one ABRAXANE dose withheld or delayed
Dosing recommendations:
  • Administer ABRAXANE followed by gemcitabine 1000 mg/m2 on Days 1, 8, and 15 of each 28-day cycle
  • ABRAXANE is administered intravenously over 30-40 minutes
Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.
  • aAccording to NCCN Chemotherapy Order Templates: peer-reviewed statements of consensus of its authors derived from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®).
  • Use in Patients With Hepatic Impairment

    STARTING DOSE FOR PATIENTS
    WITH HEPATIC IMPAIRMENT

    Starting Dose for Patients with Mild Hepatic Impairment Starting Dose for Patients with Mild Hepatic Impairment
    • Patients with bilirubin levels above the ULN were excluded from the MPACT study (central lab ULN in the MPACT study was 1.5 mg/dL)
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  • MPACT Modifications Timing

    UNDERSTANDING TIMING OF DOSE MODIFICATIONS
    DURING ABRAXANE + GEMCITABINE THERAPY11
    UNDERSTANDING TIMING OF DOSE MODIFICATIONS DURING ABRAXANE + GEMCITABINE
    THERAPY
    11

    ABRAXANE Starting Dose is 125 mg/m2 given QW3/4 in metastatic pancreatic cancer ABRAXANE Starting Dose is 125 mg/m2 given QW3/4 in metastatic pancreatic cancer ABRAXANE Starting Dose is 125 mg/m2 given QW3/4 in metastatic pancreatic cancer
    • a First 2 cycles.
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  • % of ABRAXANE Patients Receiving 125 mg/m2 at the Start of Each Treatment Cycle

    THE APPROVED STARTING DOSE OF 125 mg/m2

    Percentage of ABRAXANE patients receiving 125 mg/m2 at the start of each treatment cycle11a Percentage of ABRAXANE patients
    receiving 125 mg/m2 at the start of each treatment cycle11a
    Percentage MPAC patients receiving the ABRAXANE starting dose of 125mg/m2 at the start of each treatment cycles (Cycles 1-5) Percentage MPAC patients receiving the ABRAXANE starting dose of 125mg/m2 at the start of each treatment cycles (Cycles 1-5)
    • Median duration of treatment: 3.9 months (range 0.1 to 21.9 months)1
    • aWithin the MPACT study there were also dose modifications to the gemcitabine dose within the ABRAXANE + gemcitabine arm. Those modifications
      are not shown here.
      aWithin the MPACT study there were also dose modifications to the gemcitabine dose within the ABRAXANE + gemcitabine arm. Those modifications are not shown here.
    • bCycle 1=8 weeks; subsequent cycles=4 weeks each.
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A FIRST-LINE STANDARD OF CARE FOR PATIENTS ACROSS A BROAD RANGE OF PERFORMANCE STATUS (KPS 70-100)1,6

ABRAXANE + gemcitabine NCCN Category 1 recommendation for Patients with Good PS and some patients with PS 2 (KPS >=70) ABRAXANE + gemcitabine NCCN Category 1 recommendation for Patients with Good PS and some patients with PS 2 (KPS >=70)
Albumin-bound paclitaxel (ABRAXANE) + gemcitabine as first-line therapy allows for a treatment plan with 5–FU-based second-line therapy12
  • aCategory 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
  • bGood performance status for this regimen (AG) is defined as KPS ≥70, so some patients with an ECOG score of 2 may be eligible to receive this regimen (AG).
  • cAccording to the NCCN Chemotherapy Order Templates: Peer-reviewed statements of consensus of its authors derived from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)
  • The albumin-bound paclitaxel (ABRAXANE) phase III MPACT study enrolled patients with KPS ≥70.12
    Good performance status is defined as ECOG 0-1 with patent biliary stent and adequate nutritional intake.
    Please refer to the NCCN Guidelines for pancreatic cancer for a complete list of recommended treatment options.

PREFERRED FIRST-LINE REGIMEN OPTIONS FOR PATIENTS WITH METASTATIC PANCREATIC CANCER AND GOOD PS1,6 PREFERRED FIRST-LINE REGIMEN OPTIONS FOR PATIENTS WITH METASTATIC PANCREATIC CANCER AND GOOD PS1,6

Both albumin-bound paclitaxel (ABRAXANE) + gemcitabine and FOLFIRINOX are preferred first-line regimens for patients with good performance status (PS)a in NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®)1 for metastatic pancreatic cancer12
ABRAXANE + gemcitabine & FOLFIRINOX are NCCN Category 1 preferred first line regimens for patients with metastatic pancreatic cancer and good PS ABRAXANE + gemcitabine & FOLFIRINOX are NCCN Category 1 preferred first line regimens for patients with metastatic pancreatic cancer and good PS
There have been no head-to-head clinical trials comparing safety and efficacy of albumin-bound paclitaxel (ABRAXANE) + gemcitabine and FOLFIRINOX
Additional first-line Category 1 regimens for metastatic disease include gemcitabine monotherapy and gemcitabine + erlotinib.12
  • aGood performance status is defined as ECOG 0-1 with patent biliary stent and adequate nutritional intake.
  • bCategory 1: Based upon high-level evidence, there is uniform National Comprehensive Cancer Network® (NCCN®) consensus that the intervention is appropriate.

    Please refer to the NCCN Guidelines® for pancreatic cancer for a complete list of recommended treatment options, including Category 2A and 2B treatment options for metastatic patients with good performance status.

WELL-ESTABLISHED SAFETY PROFILE

Most common ARs (≥20%) with a ≥5% higher incidence for ABRAXANE/gemcitabine arm
Most common adverse reactions of the MPACT trial Most common adverse reactions of the MPACT trial
  • ABRAXANE + gemcitabine had the same incidence of death due to adverse reactions compared to gemcitabine alone (4% of patients in each arm)2
  • Disease progression was the most common reason for treatment discontinuation2
  • The most common ARs resulting in permanent discontinuation of ABRAXANE were:
    8% peripheral neuropathy | 4% fatigue | 2% thrombocytopenia
    The most common ARs resulting in permanent discontinuation of ABRAXANE were: 8% peripheral neuropathy | 4% fatigue | 2% thrombocytopenia
  • Selected Adverse Reactions

    WELL-ESTABLISHED SAFETY PROFILE

    Higher incidence (≥5% for all grade toxicity or ≥2% Grade 3 or higher toxicity)
    in the ABRAXANE + gemcitabine arm
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  • Most Serious Adverse Reactions

    WELL-ESTABLISHED SAFETY PROFILE

    Most common serious ARs (with a ≥1% higher incidence) for ABRAXANE + gemcitabine arm Most common serious ARs (with a ≥1% higher incidence) for ABRAXANE
    + gemcitabine arm
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UNDERSTANDING PERIPHERAL NEUROPATHY
WITH ABRAXANE + GEMCITABINE
UNDERSTANDING PERIPHERAL NEUROPATHY WITH ABRAXANE + GEMCITABINE

  • 54% of patients experienced peripheral neuropathy of any grade (227/421)
Peripheral neuropathy with ABRAXANE + gemcitabine Peripheral neuropathy with ABRAXANE + gemcitabine
  • 8% of patients who received ABRAXANE + gemcitabine permanently discontinued ABRAXANE due to peripheral neuropathy

APPROPRIATE DOSE MODIFICATION FOR PERIPHERAL NEUROPATHY

Assessing the severity of peripheral neuropathy is key to determining dose modifications
No recommended for Dose modification of ABRAXANE for peripheral neuropathy: Grade 1 or 2
ABRAXANE Dose modification for peripheral neuropathy: Grade ≥3 ABRAXANE Dose modification for peripheral neuropathy: Grade ≥3

UNDERSTANDING HEMATOLOGIC ARs
WITH ABRAXANE + GEMCITABINE

UNDERSTANDING HEMATOLOGIC ARs WITH ABRAXANE + GEMCITABINE

Percentage of patients who experience Neutropenia in the ABRAXANE Phase III MPAC Study Percentage of patients who experience Thrombocytopenia in the ABRAXANE Phase III MPAC Study Percentage of patients who experience Thrombocytopenia in the ABRAXANE Phase III MPAC Study
26% of ABRAXANE + gemcitabine patients received granulocyte colony stimulating factor (G-CSF).
  • Dose Modifications for Hematologic ARs

    APPROPRIATE DOSE MODIFICATIONS FOR HEMATOLOGIC ARs

    Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Days 1, 8, and 15
    metastatic pancreatic cancer day 1
    Assess whether to begin or delay treatment cycle (based on CBC prior to dosing on Day 1)
    • Patients must have ANC ≥1500 cells/mm3 and platelet counts ≥100,000 cells/mm3 to initiate a cycle
    • If counts are not at these levels, delay the start of the cycle until recovery
    The recommended starting dose of ABRAXANE is 125 mg/m2
    metastatic pancreatic cancer day 1
    Assess whether to begin or delay treatment cycle (based on CBC prior to dosing on Day 1)
    • Patients must have ANC ≥1500 cells/mm3 and platelet counts ≥100,000 cells/mm3 to initiate a cycle
    • If counts are not at these levels, delay the start of the cycle until recovery
    The recommended starting dose of ABRAXANE is 125 mg/m2
    Adjust treatment as necessary within the cycle based on ANC and platelet counts
    (determined via CBC prior to dosing on Days 8 and 15)
    Adjust treatment as necessary within the cycle based on ANC and platelet counts
    (determined via CBC prior to dosing on Days 8 and 15)
    metastatic pancreatic cancer day 8
    metastatic pancreatic cancer day 8
    Hematologic ARs dose Modifications Day 8 Hematologic ARs dose Modifications Day 8
    Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 8 Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 8
    Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 8 Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 8
    metastatic pancreatic cancer day 15 metastatic pancreatic cancer day 15
    Treatment adjustments at Day 15 depend upon action taken at Day 8
    SELECT ACTION TAKEN ON DAY 8 ABOVE TO SEE APPROPRIATE DOSE MODIFICATIONS FOR DAY 15
    metastatic pancreatic cancer day 15 metastatic pancreatic cancer day 15
    Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15 Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15
    Dose Modification for Henatologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15 Dose Modification for Henatologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15
    Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15 Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15
    metastatic pancreatic cancer day 15 metastatic pancreatic cancer day 15
    metastatic pancreatic cancer maintain day 8 dose metastatic pancreatic cancer maintain day 8 dose
    Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15 Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15
    Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15 Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15
    metastatic pancreatic cancer day 15 metastatic pancreatic cancer day 15
    Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15 Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15
    Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15 Dose Modification for Hematologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15
    Dose Modification for Hematlologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15 Dose Modification for Hematlologic ARs at the start of each cycle for Metastatic Pancreatic cancer- Day 15
    If Grade 3 or 4 febrile neutropenia occurs, withhold ABRAXANE and gemcitabine until fever resolves and ANC ≥1500; resume at next lower dose level.
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  • Dose Level Reductions

    DOSE LEVEL REDUCTIONS

    Dose level reductions for MPAC patients Dose level reductions for MPAC patients
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Additional Information for Readers Provided by Celgene Corporation

The clinical trial described in this article served as the
basis for the approval for ABRXANE for Injectable Suspension.
The analyses contained in the article may differ from those in the package insert for ABRAXANE.

Please see Important Safety Information and Prescribing Information, including Boxed WARNING.

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