Celgene International SΠrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that its phase III clinical trial of ABRAXANE (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naίve patients with metastatic pancreatic cancer demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine alone [(median of 8.5 vs. 6.7 months) (HR 0.72, P=0.000015)].
In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, ABRAXANE plus gemcitabine demonstrated a 59% increase in one-year survival (35% vs. 22%, p=0.0002) and demonstrated double the rate of survival at two years (9% vs. 4%, p=0.02) as compared to gemcitabine alone.
ABRAXANE plus gemcitabine also demonstrated a statistically significant improvement in key secondary endpoints compared to gemcitabine alone, including a 31% reduction in the risk of progression or death with a median progression-free survival (PFS) of 5.5 vs. 3.7 months (HR 0.69, P=0.000024) and an overall response rate (ORR) of 23% compared to 7% (response rate ratio of 3.19, p=1.1 x 10-10). Another endpoint assessed included time to treatment failure, which was significantly improved with the ABRAXANE combination compared to gemcitabine alone [(median 5.1 vs. 3.6 months) (HR 0.70, P a dose-limiting toxicity of ABRAXANE /li li class="bwlistitemmargb" Monitor for myelotoxicity by performing complete blood cell counts frequently, including prior to dosing on Day 1 for metastatic breast cancer (MBC) and Days 1, 8, and 15 for non-small cell lung cancer (NSCLC) /li li class="bwlistitemmargb" Do not administer ABRAXANE to patients with baseline absolute neutrophil counts (ANC) of less than 1,500 cells/mmsup3/sup /li li class="bwlistitemmargb" In the case of severe neutropenia (500 cells/mmsup3/sup for seven days or more) during a course of ABRAXANE therapy, reduce the dose of ABRAXANE in subsequent courses in patients with either MBC or NSCLC /li li class="bwlistitemmargb" In patients with MBC, resume treatment with every-3-week cycles of ABRAXANE after ANC recovers to a level 1,500 cells/mmsup3/sup and platelets recover to >100,000 cells/mm3 In patients with NSCLC, resume treatment if recommended at permanently reduced doses for both weekly ABRAXANE and every-3-week carboplatin after ANC recovers to at least 1,500 cells/mm3 and platelet count of at least 100,000 cells/mm3 on Day 1 or to an ANC of at least 500 cells/mm3 and platelet count of at least 50,000 cells/mm3 on Days 8 or 15 of the cycle
Nervous SystemSensory neuropathy is dose- and schedule-dependent The occurrence of Grade 1 or 2 sensory neuropathy does not generally require dose modification If ≥ Grade 3 sensory neuropathy develops, treatment should be withheld until resolution to Grade 1 or 2 for MBC or until resolution to ≤ Grade1 for NSCLC followed by a dose reduction for all subsequent courses of ABRAXANE
HypersensitivitySevere and sometimes fatal hypersensitivity reactions, including anaphylactic reactions, have been reported Patients who experience a severe hypersensitivity reaction to ABRAXANE should not be re-challenged with this drug
Hepatic ImpairmentBecause the exposure and toxicity of paclitaxel can be increased with hepatic impairment, administration of ABRAXANE in patients with hepatic impairment should be performed with caution The starting dose should be reduced for patients with moderate or severe hepatic impairment
Albumin (Human)ABRAXANE contains albumin (human), a derivative of human blood
Use in Pregnancy: Pregnancy Category DABRAXANE can cause fetal harm when administered to a pregnant woman If this drug is used during pregnancy, or if the patient becomes pregnant while receiving this drug, the patient should be apprised of the potential hazard to the fetus Women of childbearing potential should be advised to avoid becoming pregnant while receiving ABRAXANE
Use in MenMen should be advised not to father a child while receiving ABRAXANE
Randomized Metastatic Breast Cancer (MBC) StudyThe most common adverse reactions (≥20%) with single-agent use of ABRAXANE in the MBC study were alopecia (90%), neutropenia (all cases 80%; severe 9%), sensory neuropathy (any symptoms 71%; severe 10%), abnormal ECG (all patients 60%; patients with normal baseline 35%), fatigue/asthenia (any 47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), AST elevation (any 39%), alkaline phosphatase elevation (any 36%), anemia (all cases 33%; severe 1%), nausea (any 30%; severe 3%), diarrhea (any 27%; severe