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DELIVER THE DIFFERENCE OF AN ALBUMIN-BOUND PACLITAXEL

ABRAXANE is an albumin-bound nanoparticle formulation

  • ABRAXANE has different pharmacokinetic (PK) properties than paclitaxel
See the PK profile of ABRAXANE
ABRAXANE is an albumin-bound nanoparticle formulation

A TRIAL REFLECTIVE OF THE PATIENTS TYPICALLY SEEN IN YOUR PRACTICE

The first Phase III trial for 1L mPC based on a real-world population3

MPACT is the largest multinational trial (861 patients) in the mPC setting

151 community and academic centers worldwide;  63% of patients treated in a community setting;  Broad range of PS; No upper age limit 151 community and academic centers worldwide;  63% of patients treated in a community setting;  Broad range of PS; No upper age limit
Broad range of PS in MPACT: Proportion of patients by KPS No upper age limit No upper age limit

Study Design

The multinational, randomized, Phase III MPACT study compared ABRAXANE + gemcitabine vs gemcitabine alone as first-line treatment in 861 patients with mPC with normal bilirubin and no prior chemotherapy in the metastatic setting. Primary endpoint was OS. ABRAXANE(125 mg/m2) + gemcitabine (1000 mg/m2) was given QW3/4. In the gemcitabine arm, gemcitabine (1000 mg/m2) was given QW7/8 then QW3/4.

1L=first-line; ECOG=Eastern Cooperative Oncology Group; KPS=Karnofsky Performance Status; MPACT=Metastatic Pancreatic Adenocarcinoma Clinical Trial; mPC=metastatic pancreatic cancer; OS=overall survival; PS=performance status; QW3/4=weekly for 3 of 4 weeks; QW7/8=weekly for 7 of 8 weeks.

UNDERSTANDING THE RELATION BETWEEN
PERFORMANCE STATUS MEASUREMENTS5-7

Karnofsky Performance Status (KPS) Eastern Cooperative Oncology Group Performance Status (ECOG PS) Karnofsky Performance Status (KPS); 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.7

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PATIENTS WERE WELL BALANCED
BETWEEN TREATMENT ARMS3

Patients were well balanced between treatment arms Patients were well balanced between treatment arms

ULN=upper limit of normal.

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Watch. Dr. Kim Discusses the Largest Multinational Phase III Study

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Dr. Kim Discusses the Largest Multinational Phase III Study

EFFICACY THAT DELIVERS

Only ABRAXANE + gemcitabine is proven to significantly improve OS across a broad range of patients3,a
Only ABRAXANE + gemcitabine is proven to significantly improve OS across a broad range of patients3

Patient performance status ranged from ECOG 0-2, with no upper age limit (age range: 27-86 years).3

Stratified using Cox proportional hazard model.

Based on a stratified log-rank test (stratified by geographic region, KPS, and presence of liver metastasis).

RESPONSE MATTERS:
ORR ASSESSED BY INDEPENDENT REVIEW

ABRAXANE (125 mg/m2 QW3/4) + gemcitabine more than tripled ORR vs gemcitabine alone
Response Matters: ORR assessed by independent review CLOSE THE TAB

ABRAXANE + GEMCITABINE
SIGNIFICANTLY IMPROVED PFSa

49% increase in median PFS with ABRAXANE (125 mg/m2 QW3/4) + gemcitabine compared with gemcitabine alone3
Abraxane + gemcitabine signficantly improved PFSa

Based on independent radiological reviewer assessment.

Stratified using Cox proportional hazard model.

Based on a stratified log-rank test (stratified by geographic region, KPS, and presence of liver metastasis).

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Watch. Dr. Kim Discusses the Largest Multinational Phase III Study

WATCH
Dr. Kim Discusses the Largest Multinational Phase III Study

GREATER THAN 1-YEAR SURVIVAL BENEFIT FOR THE FITTEST PATIENTS
(ECOG PS 0)8

Post-hoc analysis of survival by performance status

Post-hoc analysis of survival by performance status Post-hoc analysis of survival by performance status

ECOG PS 0 to 1 (KPS 90-100)

9.7 months (n=248; 95% CI: 8.71-10.91) with ABRAXANE + gemcitabine vs 7.9 months (n=268; 95% CI: 6.97-9.03) with gemcitabine (HR=0.75 [95% CI: 0.62-0.92])

ECOG PS 1 to 2 (KPS 70-80)

7.6 months (n=179; 95% CI: 6.44-8.38) with ABRAXANE + gemcitabine vs 4.3 months (n=161; 95% CI: 3.81-5.72) with gemcitabine (HR=0.61 [95% CI: 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.

Watch. Dr. Kim Discusses the Largest Multinational Phase III Study

WATCH
Dr. Kim Discusses the Largest Multinational Phase III Study

DOSING THAT DELIVERS

A well-established regimen for your patients
Dosing that delivers
  • Starting dose of 125 mg/m2
  • Administer ABRAXANE, followed by gemcitabine 1000 mg/m2, on Days 1, 8, and 15 of each 28-day cycle
  • 30- to 40-minute IV infusion

NOTE: DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS.
ABRAXANE has different dosage and administration instructions from other paclitaxel products.

A WELL-DEFINED DOSE MODIFICATION SCHEDULE

Dose level reductions for patients with mPC
Dose level reductions for patients with mPC Dose level reductions for patients with mPC

In the MPACT study4

  • 41% of patients had at least one ABRAXANE dose reduction
  • 71% of patients had at least one ABRAXANE dose withheld or delayed

STARTING DOSE FOR PATIENTS
WITH HEPATIC IMPAIRMENT

Starting dose for patients with heptic impairement
  • 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)

AST=aspartate aminotransferase; SGOT=serum glutamic-oxaloacetic transaminase.

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UNDERSTANDING TIMING OF DOSE MODIFICATIONS
DURING ABRAXANE + GEMCITABINE THERAPY9

Understanding timing of dose modications during Abraxane + gemcitabine therapy Understanding timing of dose modications during Abraxane + gemcitabine therapy

First 2 cycles.

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THE APPROVED STARTING DOSE OF 125 mg/m2

Percentage of ABRAXANE patients receiving 125 mg/m2 at the start of each treatment cycle9,a

Percentage of Abraxane patients receiving 125 mg/m<sup>2</sup> at the start of each treatment cycle Percentage of Abraxane patients receiving 125 mg/m<sup>2</sup> at the start of each treatment cycle
  • Median duration of treatment: 3.9 months (range 0.1 to 21.9 months)3

Within the MPACT study there were also dose modifications to the gemcitabine dose within the ABRAXANE + gemcitabine arm. Those modifications are not shown here.

Cycle 1=8 weeks; subsequent cycles=4 weeks each.

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VIEW
Dose Modifications for Severe Hematologic, Neurologic, Cutaneous, or Gastrointestinal Toxicity

Download now. Quick reference card for dosing schedule and dose modifcations

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Quick-reference Card for Dosing Schedule and Dose Modifications

Watch Dr. Kim Presents the Dosing and Schedule Recommendation for ABRAXANE + Gemcitabine

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Dr. Kim Presents the Dosing and Schedule Recommendation for
ABRAXANE + Gemcitabine

A PREFERRED 1L REGIMEN OPTION (CATEGORY 1 RECOMMENDATION)10

A preferred 1L regimen option (category 1 recommendation) A preferred 1L regimen option (category 1 recommendation)

Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.10

Good 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).10

According to the NCCN Chemotherapy Order Templates: Peer-reviewed statements of consensus of its authors derived from the NCCN Guidelines®.

The albumin-bound paclitaxel (ABRAXANE) Phase III MPACT study enrolled patients with KPS ≥70.10
Good performance status is defined as ECOG 0-1, with good biliary drainage and adequate nutritional intake, and ECOG 0-2 if considering gemcitabine + albumin-bound paclitaxel.10
Please refer to the NCCN Guidelines for pancreatic cancer for a complete list of recommended treatment options.
AG=ABRAXANE + gemcitabine.

NCCN Category 1

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Summary of NCCN Guidelines®: Albumin-bound Paclitaxel (ABRAXANE) + Gemcitabine as a Preferred First-Line Regimen

A 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 Most common ARs (≥20%) with a ≥5% higher incidence for ABRAXANE + gemcitabine arm
  • ABRAXANE + gemcitabine had the same incidence of death due to adverse reactions compared to gemcitabine alone (4% of patients in each arm)4
  • Disease progression was the most common reason for treatment discontinuation4
  • The most common ARs resulting in permanent discontinuation of ABRAXANE were:
    8% peripheral neuropathy | 4% fatigue | 2% thrombocytopenia

A 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

MedDRA=Medical Dictionary for Regulatory Activities.

405 patients assessed in ABRAXANE + gemcitabine–treated group.

388 patients assessed in gemcitabine-treated group.

404 patients assessed in ABRAXANE + gemcitabine–treated group.

Neutrophil growth factors were administered to 26% of patients in the ABRAXANE + gemcitabine group.

Peripheral neuropathy is defined by the MedDRA v15.0 Standardized MedDRA Query (broad scope).

Urinary 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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A WELL-ESTABLISHED SAFETY PROFILE

Most common serious ARs (with a ≥1% higher incidence) for ABRAXANE + gemcitabine arm

A well-established safety profileA well-established safety profile CLOSE THE TAB
Download now. Quick reference card for dosing schedule and dose modifcations

DOWNLOAD NOW
Quick-reference Card for Dosing Schedule and Dose Modifications

Watch Dr. Kim Presents the Dosing and Schedule Recommdation for ABRAXANE + Gemcitabine

WATCH
Dr. Kim Reviews the Well-Established Safety Profile of ABRAXANE Based on the Phase III Study

PERIPHERAL NEUROPATHY IN THE MPACT STUDY

Peripheral Neuropathy
  • 54% of patients experienced peripheral neuropathy of any grade (227/421)
  • In the 17% of patients who experienced Grade 3 peripheral neuropathy (70/421), 44% (n=31) resumed ABRAXANE at a reduced dose
    • The median time to first occurrence of Grade 3 peripheral neuropathy in the ABRAXANE arm was 140 days
    • The median time to improvement from Grade 3 peripheral neuropathy to ≤ Grade 1 was 29 days after withholding dose
  • 8% of patients who received ABRAXANE + gemcitabine permanently discontinued ABRAXANE due to peripheral neuropathy

APPROPRIATE DOSE MODIFICATIONS FOR PERIPHERAL NEUROPATHY

Assessing the severity of peripheral neuropathy is key to determining dose modifications

Grade 1 or 2 Grade 1 or 2 Grade >=3 Grade >=3

DOSE LEVEL REDUCTIONS

Dose level reductions Dose level reductions CLOSE THE TAB

CLEARLY DEFINED DOSE MODIFICATIONS FOR OTHER ARs

Clearly defined dose modifcations for other ARs Clearly defined dose modifcations for other ARs

ANC=absolute neutrophil count.

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Download now. Quick reference card for dosing schedule and dose modifcations

DOWNLOAD NOW
Quick-reference Card for Dosing Schedule and Dose Modifications

UNDERSTANDING HEMATOLOGIC ARs
WITH ABRAXANE + GEMCITABINE

Understanding hematologic Ars with Abraxane + gemcitabine Understanding hematologic Ars with Abraxane + gemcitabine

26% of ABRAXANE + gemcitabine patients received granulocyte colony stimulating factor (G-CSF).

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

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)

Day 8 adjust tretament as necessary within the cycle based on ANC and platelet counts Day 8 adjust tretament as necessary within the cycle based on ANC and platelet counts
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

If Grade 3 or 4 febrile neutropenia occurs, withhold ABRAXANE and gemcitabine until fever resolves and ANC ≥1500; resume at next lower dose level.

CBC=complete blood count.

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DOSE LEVEL REDUCTIONS

Dose level reductions Dose level reductions CLOSE THE TAB
Download now. Quick reference card for dosing schedule and dose modifcations

DOWNLOAD NOW
Quick-reference Dosing Card, including Dose Modifications for Hematologic ARs

References: 1. Paclitaxel. Package insert. Hospira, Inc; 2018. 2. Taxotere. Package insert. Sanofi-Aventis U.S. LLC; 2020. 3. Von Hoff DD, Ervin T, Arena FP, et al. Increased survival in pancreatic cancer with nab-paclitaxel plus gemcitabine. N Engl J Med. 2013;369(18):1691-1703. 4. Data on file. Bristol-Myers Squibb Company. 5. Karnofsky DA, Burchenal JH. The clinical evaluation of chemotherapeutic agents in cancer. In: MacLeod CM, ed. Evaluation of Chemotherapeutic Agents in Cancer. New York, NY: Columbia University Press; 1949:191-205. 6. Oken MM, Creech RH, Tormey DC, et al. Toxicity and response criteria of the Eastern Cooperative Oncology Group. Am J Clin Oncol. 1982;5(6):649-655. 7. Ma C, Bandukwala S, Burman D, et al. Interconversion of three measures of performance status: an empirical analysis. Eur J Cancer. 2010;46(18):3175-3183. 8. Tabernero J, Chiorean EG, Infante JR, et al. Prognostic factors of survival in a randomized phase III trial (MPACT) of weekly nab-paclitaxel plus gemcitabine alone in patients with metastatic pancreatic cancer. Oncologist. 2015;20(2):143-150. 9. Scheithauer W, Ramanathan RK, Moore M, et al. Dose modification and efficacy of nab-paclitaxel plus gemcitabine vs. gemcitabine for patients with metastatic pancreatic cancer: phase III MPACT trial. J Gastrointest Oncol. 2016;7(3):469-478. 10. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Pancreatic Adenocarcinoma V.1.2021. © National Comprehensive Cancer Network, Inc. 2020. All rights reserved. Accessed October 23, 2020. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 11. National Comprehensive Cancer Network, Inc. Chemotherapy Order Template Pancreatic Adenocarcinoma: Gemcitabine/Albumin-bound Paclitaxel. Updated August 17, 2016. Accessed May 9, 2017.