WHEN RESPONSE RATES MATTER, CHOOSE ABRAXANE

Primary endpoint was response rate in ITT population based on reconciled investigator and independent radiologic assessments of target lesions through cycle 6 (recTLRR)a ABRAXANE 260 mg/m2 IV q3w vs paclitaxel injection 175 mg/m2 IV q3w

21.5% ABRAXANE® (95% Cl: 16.19%-26.73%) vs 11.1% paclitaxel (95% Cl: 6.94%-15.09%) reconciled target lesion response rates in metastatic breast cancer (MBC) - ITT population
21.5% ABRAXANE® (95% Cl: 16.19%-26.73%) vs 11.1% paclitaxel (95% Cl: 6.94%-15.09%) reconciled target lesion response rates in metastatic breast cancer (MBC) - ITT population

  • ITT=intent-to-treat; recTLRR=reconciled target lesion response rate.
  • a recTLRR was the prospectively defined, protocol-specific endpoint, based on independent radiologic assessment of tumor responses reconciled with investigator responses (which also included clinical information) for the first 6 cycles of therapy. The recTLRR was lower than the investigator-reported response rates, which are based on all cycles of therapy.
  • b From Cochran-Mantel-Haenszel test stratified by first-line vs >first-line therapy.

IN RELAPSED OR REFRACTORY METASTATIC BREAST CANCER, RESPONSE RATES ARE AN IMPORTANT MEASURE

recTLRR: ABRAXANE vs paclitaxel injection for patients who failed combination chemotherapy or relapsed within 6 months of adjuvant chemotherapy (indicated population)

15.5% ABRAXANE® (95% CI: 9.26%-21.75%) vs 8.4% paclitaxel (95% CI: 3.85%-12.94%) reconciled target lesion response rates in relapsed or refractory metastatic breast cancer (MBC) - chart

15.5% ABRAXANE® (95% CI: 9.26%-21.75%) vs 8.4% paclitaxel (95% CI: 3.85%-12.94%) reconciled target lesion response rates in relapsed or refractory metastatic breast cancer (MBC) - chart

  • Prior therapy included an anthracycline unless clinically contraindicated.
  • recTLRR=reconciled target lesion response rate.
  • Median Time to Response

    MEDIAN TIME TO FIRST CONFIRMED RECONCILED RESPONSE WITH ABRAXANE (EXPLORATORY ENDPOINT FOR ITT)22a

    Median time to response: ABRAXANE® 5.3 weeks (range: 4.6-10.3) vs paclitaxel 6 weeks (range: 4.7-11.6) in metastatic breast cancer (MBC) - chart
    aAnalysis Limitations: Time to first reconciled response was an exploratory endpoint that was not powered to determine a treatment difference.
    CLOSE THE TAB
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 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.

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

OK
CANCEL