Biotechnology Events

Celgene Corporation

• ( NASDAQ: CELG ) ( CBOE: CELG )
• Celgene Corporation Home.

.

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&...

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

Results:

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)].
More
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).
More
Source: press release, 11/09/12. http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=17571...