Celgene Corporation
Dec 7, 2016
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tnAcity Data Presented at SABCS Evaluates the Investigational Use of ABRAXANE® as First-Line Treatment of Metastatic Triple Negative Breast Cancer

Phase II tnAcity Trial found a significantly longer Progression Free Survival with ABRAXANE + carboplatin compared to ABRAXANE + gemcitabine or carboplatin + gemcitabine regimens

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that the results of its randomized phase II tnAcity trial of ABRAXANE® for injectable suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) will be presented at the 2016 San Antonio Breast Cancer Symposium (SABCS) December 6-10, 2016. The trial found that an investigational weekly combination regimen of ABRAXANE + carboplatin had significantly longer progression-free survival (PFS) (7.4 months) compared to weekly regimens of either ABRAXANE + gemcitabine (5.4 months) or of carboplatin + gemcitabine (6.0 months) as first-line treatment of patients with metastatic triple-negative breast cancer (mTNBC).i

The phase II trial randomized 191 women with mTNBC to receive one of three weekly regimens (dosed 2 out of 3 weeks): ABRAXANE + carboplatin, ABRAXANE + gemcitabine, or carboplatin + gemcitabine as first-line treatment. The study findings demonstrated that ABRAXANE + carboplatin resulted in significantly longer PFS (7.4 months) than combination regimens with ABRAXANE + gemcitabine (5.4 months; P=0.02, HR 0.60 (95% CI, 0.39-0.93)) or carboplatin + gemcitabine (6.0 months; P= 0.03, HR 0.61 (95% CI, 0.39-0.94)). tnAcity also found that those treated with the ABRAXANE + carboplatin regimen experienced a longer median treatment duration (25 weeks) than those treated with ABRAXANE + gemcitabine (18.1 weeks) or carboplatin + gemcitabine (20.1 weeks).i

The most common grade ≥3 treatment emergent adverse events (TEAEs) observed in the ABRAXANE + carboplatin, ABRAXANE + gemcitabine, and carboplatin + gemcitabine arms, respectively, during the study were mainly hematologic and included neutropenia (42%, 27%, 52%), anemia (13%, 12%, 27%), thrombocytopenia (9%, 7%, 28%), leukopenia (6%, 3%, 11%), febrile neutropenia (5%, 2%, 0%), peripheral neuropathy (5%, 7%, 2%) and fatigue (3%, 15%, 3%). A median of 8 treatment cycles were initiated for the ABRAXANE + carboplatin arm and 6 cycles for both the ABRAXANE + gemcitabine and carboplatin + gemcitabine arms. The percentage of patients that discontinued any study drug due to a TEAE was 45% for ABRAXANE + carboplatin and 25% for each of the other arms. The most common AEs leading to discontinuation of any study drug included thrombocytopenia, anemia, neutropenia and drug hypersensitivity.i

"Metastatic triple negative breast cancer is one of the most challenging types of cancers for treating physicians and patients alike, and there remains an important unmet need in these patients to find more effective treatment options," said Dr. Denise A. Yardley, Senior Investigator, Breast Cancer Research Program; Principal Investigator, Sarah Canon Research Institute. "These data add to the body of knowledge about ABRAXANE in metastatic triple negative breast cancer, a disease that requires additional research."

After taking into consideration the rapidly changing breast cancer treatment landscape, which has a significant focus on immuno-oncology treatments, Celgene had determined not to move forward with the phase III portion of tnAcity. The Company will instead focus its breast cancer research support on ABRAXANE/Immunotherapy combinations and remains committed to applying the findings of tnAcity to ongoing and future research of ABRAXANE in breast cancer for patients with high unmet needs.

"The findings of tnAcity are encouraging, illustrating that an ABRAXANE-containing regimen may have activity in a type of breast cancer with few viable treatments and these findings give researchers additional insight into how to treat metastatic triple negative breast cancer," said Michael Pehl, President, Hematology and Oncology for Celgene. "Celgene is committed to continuing to support research in breast cancer to identify regimens for patients with aggressive disease and in areas with limited treatment options."

ABRAXANE is not indicated for the first-line treatment of metastatic breast cancer, or for the treatment regimens studied in tnAcity.

ABOUT tnAcityi,ii

tnAcity is a phase II/III multicenter, open-label, randomized clinical trial conducted in 139 centers in 12 countries. The study evaluated the safety and efficacy of the investigational use of a weekly treatment regimen of ABRAXANE in combination with carboplatin or gemcitabine as a first-line treatment of women with metastatic triple negative breast cancer (mTNBC) compared to a gemcitabine + carboplatin regimen.ii

The phase II portion of the tnAcity trial evaluated 191 patients with metastatic triple negative breast cancer (mTNBC) who had received no prior systemic chemotherapy treatment for their mTNBC and had an ECOG performance status of 0 or 1. Patients were randomized to one of three treatment arms: ABRAXANE 125 mg/m2 + carboplatin AUC 2, ABRAXANE 125 mg/m2 + gemcitabine 1000 mg/m2, or carboplatin AUC 2 + gemcitabine 1000 mg/m2 dosed weekly on days 1 and 8 of a 21-day cycle. The median age in each treatment arm was 55 (ABRAXANE + carboplatin), 53 (ABRAXANE + gemcitabine) and 59 (carboplatin + gemcitabine) years. The primary endpoint of the phase II trial was investigator assessed progression free survival (PFS). Secondary endpoints evaluated in the study included overall survival (OS) and objective response rate (ORR).

Additional ABRAXANE Data Presented at SABCS

Additional investigator initiated studies presented at SABCS also evaluated the investigational uses of ABRAXANE in the neoadjuvant setting in patients with previously untreated breast cancer (GeparSepto; P5-16-03) and as induction and maintenance therapy for women with HER2-negative metastatic breast cancer (SNAP; P5-15-05).

ABOUT ABRAXANE

ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

Important Safety Information

WARNING - NEUTROPENIA

CONTRADINDICATIONS

Neutrophil Counts

Hypersensitivity

WARNINGS AND PRECAUTIONS

Hematologic Effects

Nervous System

Hypersensitivity

Hepatic Impairment

Albumin (Human)

Use in Pregnancy: Pregnancy Category D

Use in Men

ADVERSE REACTIONS

Randomized Metastatic Breast Cancer (MBC) Study

Postmarketing Experience With ABRAXANE and Other Paclitaxel Formulations

DRUG INTERACTIONS

USE IN SPECIFIC POPULATIONS

Nursing Mothers

Pediatric

Geriatric

Renal Impairment

DOSAGE AND ADMINISTRATION

Please see full Prescribing Information, including Boxed WARNING.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, FaceBook and YouTube.

Forward-Looking Statements

This press release contains forward-looking statements, which are generally statements that are not historical facts. Forward-looking statements can be identified by the words "expects," "anticipates," "believes," "intends," "estimates," "plans," "will," "outlook" and similar expressions. Forward-looking statements are based on management's current plans, estimates, assumptions and projections, and speak only as of the date they are made. We undertake no obligation to update any forward-looking statement in light of new information or future events, except as otherwise required by law. Forward-looking statements involve inherent risks and uncertainties, most of which are difficult to predict and are generally beyond our control. Actual results or outcomes may differ materially from those implied by the forward-looking statements as a result of the impact of a number of factors, many of which are discussed in more detail in our Annual Report on Form 10-K and our other reports filed with the Securities and Exchange Commission.

i Yardley D, et al. nab-Paclitaxel + Carboplatin or Gemcitabine vs Gemcitabine + Carboplatin as First-Line Treatment for Patients With Triple-Negative Metastatic Breast Cancer: Results From the Randomized Phase II Portion of the tnAcity Trial. Poster 874. Presented at the 2016 San Antonio Breast Cancer Symposium (SABCS), December 6-10, 2016.

ii Clinicaltrials.gov. Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer) (tnAcity). Available at: https://www.clinicaltrials.gov/ct2/show/NCT01881230?term=tnacity&rank=1. Accessed November 29, 2016.

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