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ABRAXANE + CARBOPLATIN + PEMBROLIZUMAB
FOR 1L SQUAMOUS mNSCLC5

KEYNOTE-407: Phase III trial regardless of PD-L1 expression11,12

Statistically significant improvement in median OS: ITT population11,12

15.9

months

Pembrolizumab + carboplatin + either paclitaxel or ABRAXANE (95% CI: 13.2 to not estimable)

11.3

months

Placebo + carboplatin + either paclitaxel or ABRAXANE (95% CI: 9.5-14.8) (HR for death, 0.64; 95% CI: 0.49-0.85*; P=0.0017)

Median progression-free survival (coprimary endpoint)12

6.4

months

(95% CI: 6.2-8.3) in the pembrolizumab combination group

4.8

months

(95% CI: 4.3-5.7) in the placebo combination group (HR: 0.56; 95% CI: 0.45-0.70; P<0.0001).

Adverse events11
The most common adverse events (incidence ≥15%) in the KEYNOTE-407 study were anemia, alopecia, neutropenia, nausea, thrombocytopenia, diarrhea, decreased appetite, constipation, fatigue, asthenia, arthralgia, peripheral neuropathy, vomiting, cough, and dyspnea.
40% of the study population received ABRAXANE12
NCCN Guidelines Recommendations10‡
Initial Systemic Therapy
Advanced or Metastatic Squamous Cell NSCLC

Albumin-bound paclitaxel (ABRAXANE)
+ carboplatin + pembrolizumab
Category 1 for PD-L1 ≥50%§
Category 1 Preferred for PD-L1 1%-49%§

Albumin-bound paclitaxel (ABRAXANE) + carboplatin + pembrolizumab is a treatment option included in the NCCN Guidelines for Non-Small Cell Lung Cancer with a Category 1 (preferred) recommendation for the first-line treatment of patients with metastatic NSCLC squamous cell carcinoma and PD-L1 1%-49% (PS 0-1)||,¶

Dosing in the KEYNOTE-407 study12
In the pembrolizumab combination arm (n=278):
  • For each 21-day cycle for 4 cycles
    • Pembrolizumab 200 mg Day 1 +
    • Carboplatin AUC 6 mg•mL/min Day 1 +
    • Paclitaxel 200 mg/m2 Day 1 or ABRAXANE 100 mg/m2 Days 1, 8, 15#
In the placebo combination arm (n=281):
  • For each 21-day cycle for 4 cycles
    • Placebo Day 1 +
    • Carboplatin AUC 6 mg•mL/min Day 1 +
    • Paclitaxel 200 mg/m2 Day 1 or ABRAXANE 100 mg/m2 Days 1, 8, 15#

ABRAXANE SELECTED Safety Information

  • ABRAXANE has the following warnings and precautions: hematological effects, nervous system, hypersensitivity, hepatic impairment, albumin (human), embryo-fetal toxicity

Pembrolizamub SELECTED Safety Information

  • Pembrolizumab has the following warnings and precautions: immune-mediated pneumonitis, immune-mediated colitis, immune-mediated hepatitis, immune-mediated endocrinopathies, immune-mediated nephritis, immune-mediated skin adverse reactions including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), other immune-mediated adverse reactions, infusion-related reactions, complications of allogeneic HSCT, increased mortality in patients with multiple myeloma when pembrolizumab is added to a thalidomide analogue and dexamethasone, and embryo-fetal toxicity
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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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