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

THE MPACT STUDY INCLUDED PATIENTS

TYPICALLY SEEN IN REAL-WORLD PRACTICE1-3

metastatic pancreatic cancer study patients metastatic pancreatic cancer study patients
Broad range of PS
(% patients)1,2
Broad range of PS (% patients)1,2
ABRAXANE + gemcitabine arm ABRAXANE + gemcitabine arm metastatic pancreatic cancer performance status range graph metastatic pancreatic cancer performance status range graph KPS=Karnofsky Performance Status. KPS=Karnofsky Performance Status.

Tumor burden1,3
metastatic pancreatic cancer tumor burden metastatic pancreatic cancer tumor burden
No upper age limit
(% patients)1,2
No upper age limit (% patients)1,2
ABRAXANE + gemcitabine arm ABRAXANE + gemcitabine arm metastatic pancreatic cancer age limit graph metastatic pancreatic cancer age limit graph
  • 25% (n=106) of patients
    were 70 years or older
  • 10% (n=41) of patients
    were 75 years or older
  • 25% (n=106) of patients were 70 years or older
  • 10% (n=41) of patients were 75 years or older
  • U.S. MPACT Study Sites

    DIVERSITY IN THE MPACT STUDY:

    CONDUCTED IN COMMUNITY AND ACADEMIC SETTINGS IN THE U.S. AND MULTIPLE OTHER COUNTRIES
    CONDUCTED IN COMMUNITY AND ACADEMIC SETTINGS
    IN THE U.S. AND MULTIPLE OTHER COUNTRIES
    The MPACT study sites
    metastatic pancreatic cancer study sites map metastatic pancreatic cancer study sites map
    55% (476/861) of study patients were enrolled in the U.S.1
    • 37% academic setting2
    • 63% community setting2
    • 37% academic setting2
    • 63% community setting2
    metastatic pancreatic cancer study sites table metastatic pancreatic cancer study sites table
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  • Conversion: KPS to ECOG PS
    UNDERSTANDING

    PERFORMANCE STATUS MEASUREMENTS4,5

    metastatic pancreatic cancer KPS table
    metastatic pancreatic cancer ECOG PS table

    This proposed conversion scale was constructed empirically from a sample of patients (n=1385) with advanced cancer, including different tumor types. Both ECOG PS and KPS were determined by 7 physicians for each patient. This conversion scale had the highest rate of agreement (75%) observed among all possible scales.6

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  • Patients Were Well Balanced
    Between Treatment Arms

    PATIENTS WERE WELL BALANCED BETWEEN TREATMENT ARMS1

    metastatic pancreatic cancer treatment arms table metastatic pancreatic cancer treatment arms table
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WELL-ESTABLISHED

SAFETY PROFILE
Most common ARs (≥20%) with a ≥5% higher incidence for ABRAXANE/gemcitabine arm
Most common ARs (≥20%) with a ≥5% higher incidence for ABRAXANE/gemcitabine arm
metastatic pancreatic cancer safety adverse reactionsmetastatic pancreatic cancer safety adverse reactions
  • 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
  • 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
  • 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
    Higher incidence (≥5% for all grade toxicity or ≥2% Grade 3 or higher toxicity) in the ABRAXANE/gemcitabine arm
    metastatic pancreatic cancer safety selected adverse reactionsmetastatic pancreatic cancer safety selected adverse reactions
    • MedDRA=Medical Dictionary for Regulatory Activities.
    • a405 patients assessed in ABRAXANE/gemcitabine-treated group.
    • b388 patients assessed in gemcitabine-treated group.
    • c404 patients assessed in ABRAXANE/gemcitabine-treated group.
    • dNeutrophil growth factors were administered to 26% of patients in the ABRAXANE/gemcitabine group.
    • ePeripheral neuropathy is defined by the MedDRA v15.0 Standardized MedDRA Query (broad scope).
    • fUrinary tract infections includes the preferred terms of: urinary tract infection, cystitis, urosepsis, urinary tract infection bacterial, and urinary tract infection enterococcal.
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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
    metastatic pancreatic cancer safety serious adverse reactionsmetastatic pancreatic cancer safety serious adverse reactions
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UNDERSTANDING PERIPHERAL NEUROPATHY

UNDERSTANDING
PERIPHERAL NEUROPATHY

WITH ABRAXANE + GEMCITABINE1,2
  • 54% of patients taking ABRAXANE + gemcitabine experienced peripheral neuropathy of any grade (227/421)
metastatic pancreatic cancer neuropathy pie chartmetastatic pancreatic cancer neuropathy pie chart
  • 8% of patients who received ABRAXANE + gemcitabine permanently discontinued ABRAXANE due to peripheral neuropathy

RECOMMENDED DOSE MODIFICATION

FOR PERIPHERAL NEUROPATHY
metastatic pancreatic cancer neuropathy dose modification grade 1 or 2
metastatic pancreatic cancer neuropathy dose modification grade 3
metastatic pancreatic cancer neuropathy dose modification grades 1 2 3

UNDERSTANDING HEMATOLOGIC ARs

UNDERSTANDING HEMATOLOGIC ARs

IN THE MPACT STUDY
metastatic pancreatic cancer hematologic ARs chart metastatic pancreatic cancer hematologic ARs chart
Hematologic dose modifications for patients on ABRAXANE + gemcitabine
metastatic pancreatic cancer hematologic ARs table metastatic pancreatic cancer hematologic ARs table
  • 26% of ABRAXANE + gemcitabine patients received G-CSF

G-CSF=Granulocyte colony stimulating factor.

  • 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
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  • Dose Level Reductions

    DOSE LEVEL REDUCTIONS

    FOR PATIENTS WITH MPAC
    metastatic pancreatic cancer dose level reductions chart metastatic pancreatic cancer dose level reductions chart
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CHOOSE ABRAXANE + GEMCITABINE

AN ESTABLISHED FIRST-LINE STANDARD OF CARE
IN YOUR TREATMENT PLAN1,7

metastatic pancreatic cancer nccn guidelinesmetastatic pancreatic cancer nccn guidelines
*In the ABRAXANE phase III MPACT study population, 7% (30/429) of patients who received ABRAXANE +  gemcitabine were classified as KPS 70.1
* In the ABRAXANE phase III MPACT study population, 7% (30/429) of patients who received ABRAXANE + gemcitabine were classified as KPS 70.1
After first-line ABRAXANE + gemcitabine in the MPACT study, 38% of patients received
subsequent therapy, a large majority of which were fluoropyrimidine based2
After first-line ABRAXANE + gemcitabine in the MPACT study, 38% of patients received
subsequent therapy, a large majority of which were fluoropyrimidine based2
metastatic pancreatic cancer first-line therapymetastatic pancreatic cancer first-line therapy
  • Per protocol, patients were treated until disease progression or unacceptable toxicity2
  • Gemcitabine-based followed by 5-FU–based therapy is a treatment plan supported by NCCN Clinical Practice Guidelines (NCCN Guidelines®)9
  • Per protocol, patients were treated until disease progression or unacceptable toxicity2
  • Gemcitabine-based followed by 5-FU–based therapy is a treatment plan supported by NCCN Clinical Practice Guidelines (NCCN Guidelines®)9
  • Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.9

CHOOSE ABRAXANE + GEMCITABINE:

AN ESTABLISHED FIRST-LINE STANDARD OF CARE IN YOUR TREATMENT PLAN

CHOOSE ABRAXANE + GEMCITABINE:

AN ESTABLISHED FIRST-LINE STANDARD OF CARE IN YOUR TREATMENT PLAN

ABRAXANE + GEMCITABINE SIGNIFICANTLY INCREASED OVERALL SURVIVAL VS GEMCITABINE ALONE IN FIRST-LINE MPAC

Median OS

ABRAXANE + gemcitabine

8.5 months

(n=431)
(95% CI: 7.9-9.5)

VS

VS

Gemcitabine

Gemcitabine

6.7 months

(n=430)
(95% CI: 6.0-7.2)

P<0.001a

HR: 0.72 (95% CI: 0.62-0.83)b

OVERALL RESPONSE RATE WAS MORE THAN TRIPLED, AS MEASURED BY INDEPENDENT ASSESSMENT

ABRAXANE + gemcitabine

23%

(n=99/431)
(95% CI: 19%-27.2%)

VS

VS


Gemcitabine

7%

(n=31/430)
(95% CI: 5.0%-10.1%)

OVERALL RESPONSE RATE WAS
MORE THAN TRIPLED, AS MEASURED BY
INDEPENDENT ASSESSMENT

 

ABRAXANE + gemcitabine

23%

(n=99/431)
(95% CI: 19.1%-27.2%)

VS

Gemcitabine

7%

(n=31/430)
(95% CI: 5.0%-10.1%)

P<0.001c

Response rate ratio: 3.19

Study design

The multinational, randomized, phase III MPACT study compared ABRAXANE + gemcitabine vs gemcitabine alone as first-line treatment in 861 patients with MPAC.


Aim for the results achieved in the MPACT Study

Use the recommended starting ABRAXANE dose, schedule (125 mg/m2 given QW3/4), and dose modifications. Administer ABRAXANE intravenously followed by gemcitabine (1000 mg/m2) on Days 1, 8, and 15 of each 28-day cycle.

  • aStratified log-rank test stratified by geographic region (North America vs Others), KPS (70-80 vs 90-100), and presence of liver metastasis (yes vs no).
  • bStratified using Cox proportional hazard model
  • cP-value is based on chi-square test.
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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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