PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.
Robert J. Hugin, President and CEO, updated guidance for data from the Abraxane for Melanoma and Pancreatic cancer programs. He stated, "Substantial progress is being achieved in our Abraxane programs. We are now preparing for the launch of Abraxane's new indication in Non-small cell lung cancer in the United States with FDA approval anticipated in October. We are also expecting data from our phase III Melanoma study in the next several months and data from our pivotal study in Pancreatic cancer in late 2012 or early 2013."
Source: Q2 2012, earnings conference call, 7/26/12.
These results are from an investigational study. ABRAXANE® is not indicated for the treatment of resectable pancreatic cancer. ABRAXANE® is currently being evaluated in the MPACT trial, a randomized Phase III study comparing the combination of nab-paclitaxel and gemcitabine to gemcitabine alone in metastatic pancreatic cancer patients. The study has completed accrual with results expected in late 2012.
Source: press release, 6/04/12. http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=17022...
Robert J. Hugin, President and CEO, commented on the clinical and regulatory progress being made for Abraxane. He stated, "Our hematology/oncology portfolio was also strengthened by clinical and regulatory progress achieved with Abraxane. Our supplemental New Drug Application for Abraxane in non-small cell lung cancer has been filed with the FDA and has an October PDUFA date. During the quarter, we completed enrollment in the phase III Abraxane trial in metastatic pancreatic cancer. The trial enrolled over 800 patients and will answer the question whether the addition of Abraxane to Gemcitabine meaningfully improves overall survival. If the data are consistent with phase II filings, and we will know that in the next 9 to 12 months, we believe that Abraxane would have a trans-formative impact on the treatment of the disease. I should also note that we'll see phase III data in Melanoma for Abraxane in the coming 3 to 4 months, excellent progress."
Source: Q1 2012, earnings conference call, 4/26/12.
Robert J. Hugin, President and CEO, commented on the Revlimid and Abraxane solid tumor programs enrollment progress. He stated, "Our phase III solid tumor cancer trials, Revlimid in prostate cancer and Abraxane in pancreatic cancer, are accruing rapidly, with enrollment targeted to be completed by year end."
Source: Q1 2011, earnings conference call, 4/28/11.
Robert J. Hugin, President and CEO, gave guidance for the enrollment completion for the Abraxane in pancreatic cancer program. He stated, "In pancreatic cancer where the combination of Abraxane and Gemcitabine had shown encouraging survival data in a phase II trial, we've enrolled almost 500 patients in the 800 patients phase III study and expect to complete enrollment towards the end of 2011."
Source: Q4 2010, earnings conference call, 1/27/11.
Robert J. Hugin, President and CEO, gave guidance for the enrollment completion of the phase III Abraxane plus Gemcitabine for pancreatic cancer trial. HHe stated, "We're also very encouraged by the impressive response rate and survival data seen in a phase II trial evaluating Abraxane in combination with Gemcitabine in pancreatic cancer. We are increasing the patient size of the phase III pivotal study from 630 patients to approximately 840 patients to improve the power of the trial. This phase III trial continues to enroll very well, and expected enrollment will be complete towards the end of 2011."
Source: Q3 2010, earnings conference call, 10/28/10.
A Randomized Phase III Study of Weekly ABI-007 Plus Gemcitabine Versus Gemcitabine Alone in Patients With Metastatic Adenocarcinoma of the Pancreas
Estimated Enrollment: 842
Study Start Date: March 2009
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Source: clinical trials.gov. http://clinicaltrials.gov/ct2/show/NCT00844649?term=abraxane+pancreatic&...
|Abraxane (3) Pancreatic cancer||Oncology||Pancreatic cancer||Mitotic inhibitor||Microtubules|
Mechanism of action: Abraxane is a Cremophor ELP-free, albumin-stabilized nanoparticle formulation of the natural taxane paclitaxel with antineoplastic activity. Paclitaxel binds to and stabilizes microtubules, preventing their depolymerization and so inhibiting cellular motility, mitosis, and replication. This formulation solubilizes paclitaxel without the use of Cremophor ELP and permits the administration of larger doses of this agent, which would be toxic in a Cremophor ELP-containing formulation due to Cremophor ELP's toxicity profile. Cremophor ELP is a nonionic solubilizer made by reacting castor oil with ethylene oxide in a molar ratio of 1:35, followed by a purification step.
Phase of Development: III
Event Type: Data: Phase III trial results
Dates: 2012-12-01 - 2013-02-28
Analyses of MPACT Trial Evaluating ABRAXANE® Combination Therapy for the Treatment of Advanced Pancreatic Cancer Presented at ASCO 2013
Data Suggest Treatment with ABRAXANE plus Gemcitabine Reduces Levels of CA19-9 and Increases the Frequency of PET Responses; Both Tools Found to be Potential Prognostic Factors of Overall Survival
BOUDRY, Switzerland--(BUSINESS WIRE)--Jun. 3, 2013-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG), announced several analyses of a phase III clinical trial of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in previously untreated patients with advanced pancreatic cancer. The data were presented at the American Society of Clinical Oncology (ASCO) 2013 annual meeting in Chicago.
The MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) overall trial results demonstrated that patients treated with ABRAXANE plus gemcitabine had a statistically significant improvement in overall survival compared with those treated with gemcitabine alone (median of 8.5 vs. 6.7 months; HR 0.72, p<0.0001). These data were initially presented at an oral session at ASCO GI in San Francisco on January 25, 2013.
In a June 3rd oral session, Dr. Daniel D. Von Hoff, M.D., F.A.C.P., lead principal investigator of the MPACT study, Chief Scientific Officer for Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials, and Physician-In-Chief for Translational Genomics Research Institute (TGen), presented these overall survival results, as well as data from additional exploratory efficacy endpoints.
The metabolic response rate, as measured by the percentage of patients who had a reduction of their tumor signal on positron emission tomography (PET), was independently evaluated in the first 257 patients enrolled in centers that could perform PET scans. In addition, tumor response was also evaluated by measuring the decrease in levels of a key tumor marker called carbohydrate antigen 19-9 (CA19-9).
For the 257 patients in the PET cohort, 63% of those treated with ABRAXANE plus gemcitabine had a metabolic response versus 38% of those treated with gemcitabine alone (p=0.000051). The median overall survival in the PET cohort was greater for ABRAXANE plus gemcitabine as compared to gemcitabine alone (median of 10.5 vs. 8.3 months, HR 0.71, p<0.0096).
The CA19-9 findings were presented in further detail by Dr. Gabriela Chiorean, M.D., Associate Professor of Medicine, University of Washington School of Medicine, in a June 2nd poster presentation (abstract 4058). Of the 861 patients in the MPACT study, 750 had an evaluable CA19-9 sample at baseline and at least one follow-up sample.
More patients treated with ABRAXANE plus gemcitabine achieved at least a 20% reduction in CA19-9 (61%) compared with those treated with gemcitabine alone (44%) (p<0.0001). In a landmark analysis of survival in patients who achieved a 20% reduction in CA19-9 by week 8 of treatment, patients treated with ABRAXANE/gemcitabine with a CA19-9 response had significantly improved survival over patients treated with gemcitabine alone (13.2 months vs 9.4 months, respectively) (p<0.0001).
“As we evaluate potential new therapies for patients with advanced pancreatic cancer, we also have the opportunity to learn more about the biology behind this deadly disease and to develop a greater understanding of the challenges in treating it,” said Dr. Chiorean. “These new findings add to our understanding of what factors are important for investigators to use in designing future clinical trials in pancreatic cancer and help us understand better potential predictors of treatment outcome.”
The analysis of the potential influence of prognostic factors on predicting survival was also presented in more detail in a poster on June 2nd (abstract 4059) by Dr. Malcolm Moore, M.D., Head of Medical Oncology and Hematology, Princess Margaret Hospital. In this analysis, which included all 861 patients from MPACT, key predictors at baseline of improved overall survival were identified as follows: better performance status according to the Karnofsky Performance Scale index, age under 65 years, the absence of liver metastases, fewer metastatic sites and recruitment to trial sites in North America compared to Eastern Europe (Russia and Ukraine).
After correcting for these factors, treatment with ABRAXANE plus gemcitabine was a significant independent predictor of improved overall survival (HR 0.72: p < 0.0001) and progression-free survival (HR 0.66; p < 0.0001) compared with treatment with gemcitabine alone, according to the analysis.
The most common grade 3 or 4 adverse events in MPACT for ABRAXANE plus gemcitabine versus gemcitabine alone were neutropenia (38% vs. 27%, respectively), fatigue (17% vs. 7%) and peripheral neuropathy (17% vs. 1%). In the ABRAXANE plus gemcitabine arm, the median time to improvement to Grade 1 or no neuropathy was 29 days. There was no difference in serious life-threatening toxicity (4% for each arm).
These results are from an investigational phase III clinical study. ABRAXANE is not currently approved for the treatment of advanced pancreatic cancer. The U.S. Food and Drug Administration (FDA) has assigned a Priority Review designation to the supplemental New Drug Application (sNDA) for the use of ABRAXANE in combination with gemcitabine for the first–line treatment of patients with advanced pancreatic cancer. In April 2013, the European Medicines Agency (EMA) also accepted for review a Type II Variation to the current Marketing Authorization Application (MAA) for ABRAXANE in advanced pancreatic cancer.
The results presented support Celgene’s plans for developing a phase III study investigating the activity of ABRAXANE plus gemcitabine in the adjuvant pancreatic cancer setting.
Source: press release, 6/03/13. http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=18264...
ABRAXANE® Plus Gemcitabine Demonstrates Significant Survival Advantage in Phase III Study of Patients with Advanced Pancreatic Cancer
Abraxane plus gemcitabine was superior to gemcitabine alone with statistically significant and clinically meaningful results across primary and key secondary endpoints and patient subgroups
Oral Presentation Scheduled for Friday, January 25th at ASCO’s Gastrointestinal Cancers Symposium Annual Meeting
BOUDRY, Switzerland--(BUSINESS WIRE)--Jan. 22, 2013-- Celgene International Sàrl, 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-naïve 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<0.0001)].
Source: press release, 1/22/13. http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=17768...
ABRAXANE® Demonstrates Statistically Significant Improvement in Overall Survival for Patients with Advanced Pancreatic Cancer in Phase III Study
BOUDRY, Switzerland--(BUSINESS WIRE)--Nov. 9, 2012-- Celgene International Sàrl, a subsidiary of Celgene Corporation (NASDAQ: CELG) today announced that its phase III study of ABRAXANE® (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with gemcitabine in treatment-naïve patients with advanced pancreatic cancer met its primary endpoint of overall survival. In the study, ABRAXANE in combination with gemcitabine demonstrated a statistically significant improvement in overall survival compared to patients receiving gemcitabine alone.
In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, a Celgene-sponsored, open-label, randomized, international study 861 metastatic pancreatic cancer patients were randomized to receive either ABRAXANE plus gemcitabine (125 mg/m2 followed by 1000 mg/m2 gemcitabine for 3 weeks followed by a week of rest) or gemcitabine alone (1000 mg/m2 administered weekly for 7 weeks followed by a week of rest followed by cycles of weekly administration for 3 weeks followed by one week of rest).
Source: press release, 11/09/12. http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=17571...