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In Metastatic Breast Cancer Abraxane Has Greater Anti-tumor Activity Than Taxol. Results of the Phase 3 Clinical Trials of Abraxane vs. Taxol in Metastatic Breast Cancer. William J. Gradishar, MD, FACP Professor of Medicine Northwestern University.

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results of the phase 3 clinical trials of abraxane vs taxol in metastatic breast cancer

In Metastatic Breast Cancer Abraxane Has Greater Anti-tumor Activity Than Taxol

Results of the Phase 3 Clinical Trials of Abraxane vs. Taxol in Metastatic Breast Cancer

William J. Gradishar, MD, FACP

Professor of Medicine

Northwestern University

slide2

Removal of Cremophor Resulted in Superior Anti-tumor and Intratumor Paclitaxel Concentrations in Preclinical Models

slide3
Preclinical Finding: Replacing Cremophor with Albumin Enhanced the Efficacy of Paclitaxel in Breast Cancer

Breast MX-1 tumor model

equidose paclitaxel comparison

Athymic mice with human xenografts (n = 10 per group; daily administration for 5 days)

Desai N, et al. Clin Cancer Res 2006;12(4), 1317-24

abraxane results in higher intra tumoral concentration of paclitaxel compared to taxol
Abraxane Results in Higher Intra-tumoral Concentration of Paclitaxel Compared to Taxol

Intratumor paclitaxel levels following equal doses ABI-007 and Taxol in nude mice bearing MX-1 human breast cancer xenografts

ABI-007 = 1.33 X Taxol

Desai et al. Clin Can Res, 2006.

preclinical superiority of abraxane over taxol anti tumor activity predicted results in the clinic
Preclinical Superiority of Abraxane over Taxol: Anti-tumor Activity Predicted Results in the Clinic

Athymic mice with human xenografts (n = 10 per group; daily administration for 5 days)

Lung H522 (equitoxic dose comparison)

Colon HT29 (equitoxic dose comparison)

Ovarian SKOV3 (equitoxic dose comparison)

Prostate PC3 (equitoxic dose comparison)

Desai N, et al. Clin Cancer Res 2006;12(4), 1317-24

abraxane vs taxol phase 3 clinical trial
Abraxane vs. TaxolPhase 3 Clinical Trial

Journal Clin Oncology, 2005;23.

phase 3 trial design
Phase 3 Trial Design

Abraxane 260 mg/m2IV over 30 min q 3 wk

No Standard Premedication

Randomization (1:1)N = 460

Taxol 175 mg/m2IV over 3 hrs q 3 wk

Standard Premedication with Dexamethasone and Anti-histamines

slide8
Investigator Response DemonstratingSuperior Efficacy Across All Lines of Therapyin Metastatic Breast Cancer

Replacement of Cremophor with albumin enhanced the efficacy of paclitaxel in metastatic breast cancer

Source: Abraxane NDA

slide9

Reconciled Target Lesion Response Rate

Investigator Target Lesion Response Rate

Blinded Radiologist Target Lesion Response Rate

Response Assessment Demonstrated Superiority of Cremophor-free Paclitaxel Independent of Dataset and Reviewer

Source: Abraxane NDA

abraxane response rate package insert statistically significantly higher than taxol
Abraxane Response Rate (Package Insert) Statistically Significantly Higher than Taxol

Source: Abraxane Package Insert

slide11

Prolonged Time to Disease ProgressionIndependent Radiology Laboratory Response Dataset, Investigator Response Dataset, and Follow-up Disease Progression Data

Abraxane (N = 233)

Taxol (N = 227)

P-value = 0.002

Hazard Ratio = 0.721

Proportion of no Progression

Note: P-value from log-rank test.

Source: NDA Labeling Supplement

no difference in overall survival all patients
No Difference in Overall SurvivalAll Patients

Abraxane (N = 129)

Taxol (N = 143)

P-value = 0.348

Hazard Ratio = 0.904

Proportion of no Progression

Note: P-value from log-rank test.

Source: NDA Labeling Supplement

second phase 3 randomized controlled clinical trial confirms the results from ca012
Second Phase 3 Randomized Controlled Clinical Trial Confirms the Results from CA012
  • GCP study required by the Chinese Regulatory Authorities for Approval of Abraxane in China(PI:Guan Zhong-Zen)
  • 100 Patients per arm (Abraxane vs. Taxol)
  • Dose: Abraxane 260 mg/m2, Taxol 175 mg/m2 q3w
preliminary progression free survival per protocol population study ca201
Preliminary Progression-Free SurvivalPer-Protocol Population (Study CA201)

Abraxane 260 mg/m2 (N = 94)

Taxol 175 mg/m2 (N = 93)

P-value = 0.090

HR = 0.644

Proportion Not Progressed

33% of events

hypotheses for increased anti tumor activity

50% higher paclitaxel dose

33% higher intra-tumor paclitaxel

Hypotheses for Increased Anti-tumor Activity

A Combination of Two Factors

summary abraxane is efficacious and well tolerated at a higher paclitaxel dose
Summary: Abraxane is Efficacious and Well Tolerated at a Higher Paclitaxel Dose
  • Abraxane consistently demonstrated superioranti-tumor activity compared to Taxol in metastatic breast cancer
  • There is no scientific reason to believe that Abraxane would be less effective in the adjuvant setting