Celgene Corporation
Jul 10, 2018
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Anti-PD-L1 Immunotherapy Plus ABRAXANE® Significantly Reduced the Risk of Disease Worsening or Death in Patients with Metastatic or Locally Advanced Triple Negative Breast Cancer in Phase III IMpassion130 Study

- First Phase III study to demonstrate a statistically significant progression-free survival improvement in first-line metastatic triple negative breast cancer (TNBC) -

- IMpassion130 is the third positive Phase III study to demonstrate a clinical benefit with the investigational combination TECENTRIQ® plus ABRAXANE®; studies in triple negative breast cancer and in non-small cell lung cancer -

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that the Phase III IMpassion130 study, which was sponsored by Roche, met its co-primary endpoint of progression-free survival (PFS). This is the first phase III study to demonstrate a statistically significant PFS improvement in first-line metastatic or unresectable locally advanced triple negative breast cancer (TNBC), a type of breast cancer with high unmet need.

Results demonstrated that the investigational combination of TECENTRIQ® (atezolizumab) plus ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) compared to ABRAXANE® monotherapy, as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (PFS) in patients with metastatic or unresectable locally advanced TNBC in the intention-to-treat (ITT) and PD-L1 positive populations. Overall survival is encouraging in the PD-L1 positive population at this interim analysis, and follow up will continue until the next planned analysis. Safety in the TECENTRIQ® plus ABRAXANE® arm appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination.

"The IMpassion130 results are extremely encouraging for patients with this highly aggressive form of breast cancer for which there are limited options," said Jay Backstrom, M.D., Chief Medical Officer for Celgene. "This is the third positive Phase III study to demonstrate a clinical benefit with TECENTRIQ® plus ABRAXANE® as part of a treatment regimen; the other studies evaluated this investigational combination in non-small cell lung cancer patients. These data demonstrate the potential role of ABRAXANE® as a preferred chemotherapy partner for immunotherapy combinations."

Results will be presented at an upcoming medical meeting.

ABRAXANE® is not approved in combination with TECENTRIQ® for any indication in any geography.

About the IMpassion130 Study

IMpassion130 is a Phase III multicenter, randomized, double-blind study evaluating the efficacy, safety, and pharmacokinetics of TECENTRIQ® and ABRAXANE® compared with placebo in combination with ABRAXANE® in people with locally advanced or metastatic TNBC who have not received prior systemic therapy for metastatic breast cancer. The study enrolled 902 people who were randomized equally (1:1). The co-primary endpoints were progression-free survival (PFS) per investigator assessment (RECIST 1.1) and overall survival (OS). PFS and OS were assessed in all randomized participants [intention-to-treat (ITT)] and in those whose disease expressed the PD-L1 protein. Secondary endpoints included objective response rate, duration of response and time to deterioration in Global Health Status/Health-Related Quality of Life.

During the treatment duration, people in:

About Triple Negative Breast Cancer

Breast cancer is the second most common cancer among women in the United States. According to the American Cancer Society, it is estimated that about 266,000 American women will be diagnosed with invasive breast cancer in 2018, and nearly 41,000 will die from the disease. Approximately 10-20 percent of breast cancers are triple negative breast cancer (TNBC). TNBC is an aggressive form of the disease with a high unmet need. It can be more difficult to treat because it is not sensitive to hormone therapy or medicines that target HER2.

TECENTRIQ® is a registered trademark of Genentech, a member of the Roche Group.

About ABRAXANE®

ABRAXANE 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.

ABRAXANE is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy.

Important Safety Information for ABRAXANE®

 

WARNING - NEUTROPENIA

 
  • Do not administer ABRAXANE therapy to patients who have baseline neutrophil counts of less than 1500 cells/mm3. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which may be severe and result in infection, it is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE
  • Note: An albumin form of paclitaxel may substantially affect a drug's functional properties relative to those of drug in solution. DO NOT SUBSTITUTE FOR OR WITH OTHER PACLITAXEL FORMULATIONS
 

CONTRAINDICATIONS

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

Non-Small Cell Lung Cancer (NSCLC) 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: @CelgenePinterestLinkedInFacebook 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.

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