Research & Development
Celgene Provides Update on Abraxane Combination Therapy in the Treatment of Metastatic Triple-Negative Breast Cancer and Pancreatic Cancer
14 March 2019 - - US-based biopharmaceutical company Celgene Corp. (NASDAQ: CELG) has produced two updates for Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in the treatment of metastatic triple-negative breast cancer and early stage pancreatic cancer, the company said.

Genentech, a member of the Roche Group, recently announced the accelerated approval of Tecentriq (atezolizumab) in combination with Abraxane for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer whose tumors express PD-L1 as determined by an FDA-approved test.

This indication is approved under accelerated approval based on progression-free survival. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

This combination is the first cancer immunotherapy regimen approved for breast cancer and is based on results from the Phase 3 IMpassion130 study, which demonstrated that the combination of Tecentriq plus Abraxane compared to Abraxane monotherapy, as an initial (first-line) treatment, significantly reduced the risk of disease worsening or death (progression-free survival) in patients with metastatic or unresectable locally advanced triple negative breast cancer in the PD-L1 positive populations who had not received chemotherapy for metastatic disease.

In addition, the Celgene-sponsored, pivotal, Phase 3 apact study evaluating the investigational use of Abraxane in combination with gemcitabine following surgical resection (adjuvant treatment) in patients with pancreatic cancer did not achieve the primary endpoint of improvement in disease-free survival, as confirmed by independent radiological review, compared to gemcitabine alone.

Overall survival, a secondary endpoint of the study, was improved, reaching nominal statistical significance, with Abraxane in combination with gemcitabine compared to gemcitabine alone. The safety profile observed in the apact study was consistent with previously reported studies of Abraxane.

Data from apact will be submitted to a future medical meeting.

Currently, there are more than 130 studies evaluating the use of Abraxane in patients with pancreatic cancer in combination with more than 50 novel agents.

apact is an international, multicenter, randomised, open-label, controlled Phase 3 study (ClinicalTrials.gov, NCT01964430) to assess the efficacy of Abraxane in combination with gemcitabine versus gemcitabine alone as adjuvant therapy for patients with surgically resected pancreatic adenocarcinoma.

The primary endpoint of the study was the independent assessment of disease-free survival ; secondary endpoints included overall survival and safety. The study enrolled 866 patients randomized 1: 1 to receive either Abraxane 125 mg/m2 followed by gemcitabine 1000 mg/m2, or gemcitabine 1000 mg/m2 monotherapy. Treatment was administered intravenously, weekly on Days 1, 8, and 15 of a 28-day cycle for a total of 6 cycles.

In September 2013, the US Food and Drug Administration approved Abraxane in combination with gemcitabine as first-line treatment of patients with metastatic pancreatic cancer.

The current indication remains unchanged and clinical trials continue building on the foundation of Abraxane in combination with gemcitabine for a new wave of potential treatments, such as an ongoing Phase 2 cooperative group trial with SWOG S1505 (ClinicalTrials.gov, NCT02562716) investigating the safety and effectiveness of Abraxane in combination with gemcitabine as neoadjuvant treatment for localized pancreatic head adenocarcinoma.

Abraxane is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six 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.
Abraxane is indicated for the first-line treatment of patients with metastatic adenocarcinoma of the pancreas, in combination with gemcitabine.

Celgene Corp., headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialisation 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.
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