Celgene Corporation
Feb 27, 2016
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Two Quality of Life (QoL) Interim Analyses Presented at ASCO Quality Care Symposium Represent First Results from ABOUND ABRAXANE® Lung Cancer Program

Analyses demonstrated that QoL measures were maintained or improved in patients with advanced squamous non-small cell lung cancer undergoing initial treatment with ABRAXANE and carboplatin

SUMMIT, N.J.--(BUSINESS WIRE)-- Celgene Corporation (NASDAQ:CELG) today announced that two interim analyses of exploratory quality of life (QoL) endpoints in the ongoing phase III ABOUND®.sqm clinical study investigating ABRAXANE® (paclitaxel protein-bound particles for injectable suspension)(albumin-bound) in patients with advanced, squamous non-small cell lung cancer (NSCLC) were presented at the 2016 ASCO Quality Care Symposium.

In the ABOUND.sqm study, patients received four 21-day cycles of ABRAXANE (100 mg/m2 on days 1, 8 and 15) plus carboplatin (AUC6 on day 1) and those with a response or stable disease could be randomized to receive either ABRAXANE (100 mg/m2 on days 1, 8) plus best supportive care or best supportive care alone in 21-day cycles until disease progression.

The analyses included 159 patients from the study who were evaluable for radiological response and QoL. In the two analyses 99% of patients had an ECOG performance status of 0-1 and pre-defined QoL measures including the LCSS (Global Score, Average Total Score, 3-Item Index, Average Symptom Burden Index and Lung Cancer Symptoms) and EuroQol EQ-5D-5L assessment were taken on day one of each cycle during the initial treatment phase.

The first analysis evaluated the therapeutic impact of chemotherapy on patient symptoms and activities. For all patients in the analysis, quality of life as measured by the LCSS and EuroQoL (EQ-5D-5L) was generally either maintained or improved throughout the entire treatment course.

The second analysis assessed the impact of radiological response on Quality of Life. In this analysis, 93/159 patients had an unconfirmed radiological response and 66/159 did not. Responders had a greater improvement in lung cancer symptom score, as measured by the LCSS and EQ-5D-5L scores.

Importantly, among patients who reported problems with mobility, self care, usual activities of living, pain/discomfort, or anxiety/depression prior to treatment, 38 - 47% reported complete resolution of these problems at least once during treatment. This was more pronounced in patients who achieved a radiological response, with complete resolution at least once reported in 42 - 59% of patients.

"Inclusion of quality of life measures is particularly important when so few prospective trials in advanced non-small cell lung cancer currently include such analyses," said Dr. Corey Langer of the University of Pennsylvania and lead investigator of one of the analyses. "These data demonstrate a correlation between radiologic response and patient reported quality of life."


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



Neutrophil Counts



Hematologic Effects

Nervous System


Hepatic Impairment

Albumin (Human)

Use in Pregnancy: Pregnancy Category D

Use in Men


Non-Small Cell Lung Cancer (NSCLC) Study

Postmarketing Experience With ABRAXANE and Other Paclitaxel Formulations



Nursing Mothers



Renal Impairment


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. FollowCelgene on Social Media: @CelgenePinterestLinkedInFaceBook and YouTube.

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