ABRAXANE: Pivotal Phase III study
ABRAXANE + carboplatin delivered significantly superior ORR vs paclitaxel: ITT population10


ABRAXANE + carboplatin (n=170/521); 95% CI: 28.6%-36.7%


Paclitaxel injection + carboplatin (n=132/531); 95% CI: 21.2%-28.5%
  • Median duration of response was 6.9 months vs 6.0 months (95% CI: 5.6-8.0 vs 5.6-7.1, respectively)
  • No statistically significant difference in OS between the 2 study arms (median OS 12.1 months vs 11.2 months, P=NS10)
  • P=0.005 (based on chi-square test).
41% ORR in first-line squamous:
Squamous population


ABRAXANE + carboplatin (n=94/229)


Paclitaxel injection + carboplatin (n=54/221)
Response rate in other histologies
Established safety profile
The most common ARs (≥20%) of ABRAXANE in combination with carboplatin are anemia, neutropenia, thrombocytopenia, alopecia, peripheral neuropathy, nausea, and fatigue.
NCCN Guidelines Recommendations12*
Initial Systemic Therapy
All Histologies
Advanced or Metastatic NSCLC Albumin-bound paclitaxel
(ABRAXANE) + carboplatin
NCCN Category 1

Albumin-bound paclitaxel (ABRAXANE) + carboplatin is a treatment option included in the NCCN Guidelines® for Non-Small Cell Lung Cancer with a Category 1 recommendation for the first-line treatment of metastatic squamous cell carcinoma and nonsquamous NSCLC (PS 0-1)

  • *For additional considerations and treatment options, see NCCN.org.
  • Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.
  • EGFR, ALK, ROS1, BRAF, MET exon 14 skipping mutation, and RET negative, treatment option for patients with contraindications to PD-1 or PD-L1 inhibitors. Contraindications for treatment with PD-1/PD-L1 inhibitors may include active or previously documented autoimmune disease and/or current use of immunosuppressive agents or presence of an oncogene, which would predict lack of benefit.

Study design

Multicenter, randomized 1:1, Phase III study comparing ABRAXANE (100 mg/m2 IV; Days 1, 8, and 15 of each 21-day cycle) + carboplatin (AUC=6 mg•min/mL IV, Day 1 of each 21-day cycle) with paclitaxel injection (200 mg/m2 IV, Day 1 of each 21-day cycle) + carboplatin (AUC=6 mg•min/mL IV, Day 1 of each 21-day cycle) in 1052 chemonaïve patients with advanced NSCLC. The primary efficacy endpoint was ORR.10

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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 ABRAXANE 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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