ABRAXANE® (nab-paclitaxel) plus gemcitabine demonstrates survival advantage in Phase III study of patients with advanced pancreatic cancer1

Celgene UK and Ireland, a subsidiary of Celgene Corporation (NASDAQ: CELG), today announced that its phase III clinical trial of ABRAXANE® (nab-paclitaxel) 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)].1

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, nab-paclitaxel 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.1

Nab-paclitaxel 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 nab-paclitaxel combination compared to gemcitabine alone [(median 5.1 vs. 3.6 months) (HR 0.70, P<0.0001)].1

“The past few decades have brought us very few treatment advances for patients with advanced pancreatic cancer, which is both deadly and incredibly difficult to treat with success,” said Daniel D. Von Hoff, M.D., F.A.C.P., lead principal investigator of the MPACT study and Chief Scientific Officer for Scottsdale Healthcare’s Virginia G. Piper Cancer Center Clinical Trials and Physician-In-Chief for TGen. “The fact that nab-paclitaxel plus gemcitabine demonstrated an overall survival benefit, and also did so at one and two years, is a significant step forward in offering potential new hope for our patients.”

Dr Pippa Corrie, Consultant Medical Oncologist at Addenbrooke’s Hospital, Cambridge, emphasises the importance of this new data. “At the moment, treatment options for patients with advanced pancreatic cancer are very limited, with average life expectancy around 6 months. The announcement of the MPACT study results showing significant improvements in overall survival when combining nab-paclitaxel with standard gemcitabine, lasting up to 2 years in some cases, is a major step forward in the battle against pancreatic cancer.”

The most common grade ≥ 3 treatment-related adverse events in the study for nab-paclitaxel plus gemcitabine vs. gemcitabine alone were neutropenia (38% vs. 27%), fatigue (17% vs. 7%), and neuropathy (17% vs. 1%).1 In the nab-paclitaxel plus gemcitabine arm, the median time to neuropathy improvement was 29 days. There was no difference in serious life threatening toxicity (4% in each arm). 1

“We are excited by the results of the nab-paclitaxel MPACT study and the potential this treatment combination may bring to patients with advanced pancreatic cancer,” said Jean-Pierre Bizzari, M.D., Executive Vice President, Global Head Hematology & Oncology Clinical Research, Celgene Corporation. “As the largest phase III real-world clinical trial in advanced pancreatic cancer, the clinically meaningful findings seen across key study endpoints and patient subgroups are a reflection of our ongoing commitment to develop innovative new therapies in critical areas of need.”

Further details of the study will be highlighted in a late-breaking oral presentation by Dr. Daniel D. Von Hoff:

• Abstract: LBA #148: Final results of a randomized phase III study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas. Friday, January 25th between 2:00 to 3:30 pm PST at the American Society of Clinical Oncology’s (ASCO) 2013 Gastrointestinal Cancers Symposium in San Francisco, CA. 1

Based on the results of the MPACT study, Celgene plans to submit dossiers for registration in the US and Europe during the first half of 2013 followed by submissions in other countries/regions during the second half of 2013.

These results are from an investigational phase III study. Nab-paclitaxel is not currently approved for the treatment of advanced pancreatic cancer.

About the MPACT Study

In the MPACT (Metastatic Pancreatic Adenocarcinoma Clinical Trial) study, a Celgene-sponsored, open-label, randomized, international study of 861 metastatic pancreatic cancer patients were randomized to receive either nab-paclitaxel 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). The primary endpoint for the study is improvement in overall survival. Secondary endpoints were progression-free survival, and overall response rate determined by independent radiological review. Other endpoints included progression-free survival, overall response rate determined by investigator and the safety and tolerability of this combination in this patient population.

About Advanced Pancreatic Cancer

Advanced pancreatic cancer is a difficult-to-treat cancer with the lowest survival rates among all cancer types.2 Of those diagnosed with pancreatic cancer, the 1-year survival rate is approximately 20 percent, and the 5-year survival rate is about 5 percent.3 For those diagnosed with locally advanced disease, which cannot be removed through surgery, the average life expectancy is around 7 months.3 There are two main types of pancreatic cancer – adenocarcinomas, which accounts for approximately 90% of all pancreatic cancer, and neuroendocrine tumors.4 However, pancreatic cancer is the 9th most common cancer in the UK and over 8,000 people are diagnosed each year.5 Pancreatic cancer is the 5th leading cause of cancer death in the UK.6

About Nab-paclitaxel

The European Medicines Agency (EMA) approved nab-paclitaxel, 5 mg/ml powder for suspension for infusion (paclitaxel), in 2008 for the treatment of metastatic breast cancer in patients who have failed first-line treatment for metastatic disease and for whom standard, anthracycline-containing therapy is not indicated.* The recommended dose of nab-paclitaxel is 260 mg/m2 administered intravenously over 30 minutes every 3 weeks.

*Nab-paclitaxel Summary of Product Characteristics. www.medicines.org.uk. July 2012

References

1. Randomized phase 3 study of weekly nab-paclitaxel plus gemcitabine versus gemcitabine alone in patients with metastatic adenocarcinoma of the pancreas (MPACT). Phase 3 metastatic pancreatic cancer, D Von Hoff. ASCO GI, Jan 24-26, 2013 San Francisco, CA; Late-breaking abstract.
2. Pancreatic Cancer Action. Pancreatic Cancer Statistics. http://pancreaticcanceraction.org/facts-figures/quick-statistics/. Accessed January 9, 2013
3. Cancer Research UK. Statistics and outlook for pancreatic cancer. http://www.cancerresearchuk.org/cancer-help/type/pancreatic-cancer/treatment/statistics-and-outlook-for-pancreatic-cancer. Accessed January 9, 2013
4. Pancreatic Cancer UK. Types of pancreatic cancer. http://www.pancreaticcancer.org.uk/information-and-support/facts-about-pancreatic-cancer/types-of-pancreatic-cancer. Accessed January 9, 2013
5. Pancreatic Cancer UK. Causes and risk of pancreatic cancer. http://www.pancreaticcancer.org.uk/information-and-support/facts-about-pancreatic-cancer/causes-and-risk. Accessed January 9, 2013
6. Pancreatic Action Cancer Network. Pancreatic cancer facts 2011. http://www.pancan.org/section_get_involved/advocate/downloads/Pancreatic_Cancer_Facts_Sept_2011.pdf. Accessed January 9, 2013