THE ABRAXANE PIVOTAL PHASE III TRIAL INCLUDED OVER 1000 PATIENTS WITH ADVANCED SQUAMOUS AND NONSQUAMOUS NSCLC

Study design: 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) (n=521) 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) (n=531) in 1052 chemonaïve patients. The primary endpoint was overall response rate (ORR), and the secondary endpoints were progression-free survival (PFS) and overall survival (OS).

Study design: 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) (n=521) 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) (n=531) in 1052 chemonaïve patients. The primary endpoint was overall response rate (ORR), and the secondary endpoints were progression-free survival (PFS) and overall survival (OS).

Treatment administered until disease progression or development of unacceptable toxicity

AUC=area under the curve.


Studied in a broad range of chemonaïve patients with advanced NSCLC
Studied in a broad range of chemonaïve patients with advanced NSCLC
Stratified by histologies and age8,9

ABRAXANE + carboplatin arm (n=521)

In the NSCLC study, 44% of patients had squamous cell carcinoma, 49% had adenocarcinoma, 2% had large cell carcinoma, and 6% had other types of NSCLC. 31% were ≥65 years of age, and 69% were <65 years of age.

In the NSCLC study, 44% of patients had squamous cell carcinoma, 49% had adenocarcinoma, 2% had large cell carcinoma, and 6% had other types of NSCLC. 31% were ≥65 years of age, and 69% were <65 years of
age.


Three-quarters of the patients had a history of smoking9
Three-quarters of the patients had a history of smoking9

ABRAXANE + carboplatin arm (n=519)a

In the Phase III study, 74% of patients had a history of smoking and 26% never smoked. In the Phase III study, 74% of patients had a history of smoking and 26% never smoked.

  • aThe smoking status was unknown for 2 patients in the ABRAXANE + carboplatin arm.
YOU ARE NOW LEAVING www.abraxanepro.com
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.

Click “OK” to proceed or “CANCEL” to return to
www.abraxanepro.com

OK
CANCEL