Celgene Corporation
Oct 7, 2016
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Data Presented at ESMO 2016 Adds to Understanding of Abraxane® as a Therapy for Patients with Historically Challenging Solid Tumors

Multiple presentations evaluate ABRAXANE alone or in combination with novel agents and novel regimens to treat mPAC, NSCLC, and MBC

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced results from multiple sponsored and independent studies will be presented during the European Society of Medical Oncology (ESMO) 2016 Annual Meeting evaluating the use of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) as a foundational treatment, either alone or in combination with novel agents and novel regimens, for patients with traditionally challenging cancers, including metastatic pancreatic cancer (mPAC), metastatic breast cancer (MBC) and advanced non-small cell lung cancer (NSCLC).

"Celgene continues to evaluate the safety and efficacy of ABRAXANE in patients with particularly challenging advanced diseases or with co-morbidities that limit their treatment options," said Michael Pehl, President, Hematology and Oncology for Celgene. "These data continue to shape our understanding of these difficult to treat diseases which will help evolve the current and future treatment landscapes in areas where there have been historically limited treatment options available to patients."

Investigational Research Evaluates ABRAXANE as a Foundational Treatment in mPAC, NSCLC, and MBC

The cancer treatment landscape has rapidly evolved over the last several years, with the introduction of targeted therapies and immunotherapy. While these advances have generated a lot of excitement, there are patients who may not benefit from these therapies. Celgene remains committed to continuing to explore treatments for these patients and at ESMO 2016, several studies evaluating treatment with ABRAXANE as a foundation therapy in these patients are being presented.

New data being presented from the ABOUND trials demonstrate the continued benefit of ABRAXANE/carboplatin doublet therapy in NSCLC. 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. The ABOUND trials included patients 70 years and older, as well as those with poorer performance status or squamous disease.1,2,3

Real-world outcomes data will also be presented for patients with metastatic breast cancer (MBC) including in the HR+/Her2- and TNBC subsets treated with ABRAXANE. 4,5

The use of ABRAXANE in first line mPAC is further investigated by multiple independent studies being reported at ESMO.

Investigating ABRAXANE as a Chemotherapy Foundation with Novel Agents

In addition, there is also emerging data that further evaluates ABRAXANE's use in challenging oncological diseases which illustrates the medical interest in ABRAXANE as a chemotherapy foundation in research with novel agents.

Currently, there are 180 clinical studies evaluating ABRAXANE combinations, including novel agents.10 At this year's ESMO, 15 independent studies are presented which evaluate ABRAXANE as a combination therapy with other agents across several tumor types including: TNBC - durvalumab (Poster 221TIP), mPAC - cisplatin, capecitabine, gemcitabine, FOLFIRINOX, ipafricept, vantictumab, PEGPH20, nivolumab (Posters 681P - Reni, 367PD - Weekes, 677P - Messersmith, 682P - Giommoni, and 715 TiP - Van Cutsem), and NSCLC - nivolumab, necitumumab (Posters 1059P - George and 1298 TiP - Socinski).

In addition, Celgene is presenting preliminary tolerability data evaluating the investigational combination use of ABRAXANE with the immunotherapy agent nivolumab (Poster 1059P) in NSCLC and mPAC. The study has been expanded and patients are currently enrolling in part 2. Additional data on the safety and efficacy of this combination in multiple tumor types will be presented at a future medical meeting.11

Update of ESMO Clinical Practice Guidelines

The latest edition of ESMO lung cancer guidelines have been updated to recommend use of ABRAXANE + carboplatin in patients with stage IV NSCLC. The recommendation is based on the pivotal trial that was conducted for ABRAXANE.12

About ABRAXANE® (nab-paclitaxel)

ABRAXANE® is a nanotechnology agent that is currently the only albumin-based nanotechnology therapy approved for the treatment of metastatic breast cancer, non-small cell lung cancer and pancreatic cancer in the United States, Europe and other markets around the world. It contains albumin-bound paclitaxel nanoparticles and is manufactured using patented nab® technology. ABRAXANE is formulated with albumin, a human protein, and is free of solvents.

ABRAXANE was first approved in January 2005 by the U.S. Food and Drug Administration (FDA) 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. In Europe, ABRAXANE was approved in January 2008 as monotherapy for the treatment of metastatic breast cancer in adult patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated. ABRAXANE is now approved in more than 50 countries for the treatment of metastatic breast cancer.

In October 2012, ABRAXANE was approved by the FDA for the first-line treatment of locally advanced or metastatic non-small cell lung cancer (NSCLC), in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE is also approved for the treatment of NSCLC in Argentina, Australia, Chile, Ecuador, Guatemala, Hong Kong, Japan, New Zealand and Singapore.

In September 2013, the FDA approved ABRAXANE as first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine. In December 2013, ABRAXANE in combination with gemcitabine was approved for first-line treatment of adult patients with metastatic adenocarcinoma of the pancreas in EuropeABRAXANE is also approved for the treatment of metastatic pancreatic cancer in more than 40 countries.

Important Safety Information

WARNING - NEUTROPENIA

CONTRAINDICATIONS

Neutrophil Counts

Hypersensitivity

WARNINGS AND PRECAUTIONS

Hematologic Effects

Nervous System

Sepsis

Pneumonitis

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

Pancreatic Adenocarcinoma 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.

Please refer to the Summary of Product Characteristics for full European prescribing information.

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.

References

1 Weiss J, et al. Quality of Life (QoL) in Elderly Patients (pts) With Advanced NSCLC Treated With nab-Paclitaxel (nab-P) + Carboplatin (C): Interim Results From the ABOUND.70+ Study. Poster 1280P. Presented at the 2016 European Society of Medical Oncology (ESMO) Annual Meeting, October 7-11, 2016.

2 Gajra A, et al. Interim Safety Results From the Phase 2 ABOUND.PS2 Study Evaluating nab-P + Carboplatin (C) Followed by nab-P Monotherapy in Patients (pts) With NSCLC and ECOG PS 2. Poster 1278P. Presented at the 2016 European Society of Medical Oncology (ESMO) Annual Meeting, October 7-11, 2016.

3 Thomas M, et al. nab-P + Carboplatin (C) Induction Therapy in Patients (Pts) With Squamous (SCC) NSCLC: Interim Quality of Life (QoL) Outcomes From the Phase 3 ABOUND.sqm Study. Poster 1279P. Presented at the 2016 European Society of Medical Oncology (ESMO) Annual Meeting, October 7-11, 2016.

4 Parisi M, et al. Real-World Comparative Effectiveness Analysis of Second-Line (2L) nab-Paclitaxel (nab-P) vs Eribulin (Erib) in Patients (Pts) With Metastatic Breast Cancer. Poster 1030P. Presented at the 2016 European Society of Medical Oncology (ESMO) Annual Meeting, October 7-11, 2016.

5 Pelletier C, et al. Real-World Comparative Effectiveness Analysis of Second-Line (2L) nab-Paclitaxel (nab-P) vs Paclitaxel (Pac) in Patients (Pts) with MBC. Poster 1029P. Presented at the 2016 European Society of Medical Oncology (ESMO) Annual Meeting, October 7-11, 2016.

6 Assenat E, et al. Gabrinox: A phase I-II of nab-paclitaxel plus gemcitabine followed by folfirinox in metastatic pancreatic adenocarcinoma. Poster 679P. Presented at the 2016 European Society of Medical Oncology (ESMO) Annual Meeting, October 7-11, 2016.

7 Reni M, et al. Randomized phase 2 trial of nab-paclitaxel plus gemcitabine, ± capecitabine, cisplatin (PAXG regimen) in unresectable or borderline resectable pancreatic adenocarcinoma. Poster 681P. Presented at the 2016 European Society of Medical Oncology (ESMO) Annual Meeting, October 7-11, 2016.

8 Zur Hausen G, et al. nab-paclitaxel/Gemcitabine First Line Therapy in Patients with Metastatic Pancreatic Carcinoma and High-Bilirubin values - Data from the German QoliXane Pancreatic Cancer Registry. Poster 684P. Presented at the 2016 European Society of Medical Oncology (ESMO) Annual Meeting, October 7-11, 2016.

9 Wang Y, et al. Impact of age, bilirubin, and disease burden in unresectable pancreatic cancer patients receiving first-line chemotherapy: A population-based analysis. Poster 683P. Presented at the 2016 European Society of Medical Oncology (ESMO) Annual Meeting, October 7-11, 2016.

10 Clinical Trials.gov. List of studies with nab-paclitaxel. Available at: https://clinicaltrials.gov/ct2/results?term=nab-paclitaxel. Accessed September 28, 2016.

11 George B, et al. Phase I study of nivolumab (nivo) + nab-paclitaxel (nab-P) in solid tumors: results from the pancreatic cancer (PC) and non-small cell lung cancer (NSCLC) cohorts. Poster 1059P. Presented at the 2016 European Society of Medical Oncology (ESMO) Annual Meeting, October 7-11, 2016.

12 Novello S, et al. Metastatic non-small-cell lung cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology 27 (Supplement 5): v1-v27, 2016. Accessed October 3, 2016. Available at: http://www.esmo.org/Guidelines/Lung-and-Chest-Tumours/Metastatic-Non-Small-Cell-Lung-Cancer.

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Source: Celgene Corporation

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