New Data Demonstrate Anti-Tumor Activity for ABRAXANE® Combination Chemotherapy Regimen in Patients with Metastatic Pancreatic Cancer
Results from Study Evaluating ABRAXANE in Combination with Gemcitabine for the Treatment of Metastatic Pancreatic Cancer Presented at 45th Annual Meeting of the American Society of Clinical Oncology
LOS ANGELES--(BUSINESS WIRE)--Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced results from an ongoing phase I/II clinical study evaluating ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) (100, 125 or 150 mg/m2) administered in combination with the standard chemotherapy gemcitabine (1,000 mg/m2), for the treatment of patients with advanced metastatic pancreatic cancer. In a preliminary analysis of 67 patients, investigator-assessed results showed the median survival rate for patients treated with the ABRAXANE/gemcitabine combination was 10.3 months across all dose levels. The combination also resulted in a disease control rate (confirmed complete response (CR), partial response (PR) and stable disease for 16 weeks or longer according to RECIST criteria) of 70 percent. Five percent of patients achieved a CR, 39 percent of patients achieved a PR and 26 percent of patients had stable disease for 16 weeks or longer. Study results also showed a higher response rate among patients who expressed the biomarker, secreted protein acidic and rich in cysteine (SPARC), compared to SPARC negative patients. More specifically, eighty percent of SPARC-positive patients (8 of 10) achieved a response compared to 36 percent (8 of 22) of SPARC-negative patients, (p=0.027). These findings were presented in a poster discussion session of Abstract #4525 on May 31st at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Fla.
Pancreatic cancer can be particularly hard to treat because many patients are diagnosed after their disease has progressed. This year, more than 42,000 people are expected to be diagnosed with pancreatic cancer in the United States and more than 35,000 people will die from the disease.i
“The results of this study demonstrate that the combination of ABRAXANE and gemcitabine is well tolerated and has substantial antitumor activity in patients with pancreatic cancer, thus warranting further evaluation in phase III clinical studies,” said Daniel Von Hoff, M.D., F.A.C.P., Physician-in-Chief, Senior Investigator, Translational Genomics Research Institute (TGen); Clinical Professor of Medicine, University of Arizona; and Chief Scientific Officer, Scottsdale Healthcare and U.S. Oncology Research. “The 80 percent response rate observed in SPARC-positive patients may suggest that metastatic pancreatic cancer patients with high levels of the SPARC biomarker may have an increased response to ABRAXANE treatment due to its albumin-bound delivery mechanism.”
About the Study
SPARC correlation with response to gemcitabine (G) plus nab-paclitaxel (nab-P) in patients with advanced metastatic pancreatic cancer: A phase I/II study (Abstract #4525)
In this phase I/II study, 67 patients with advanced metastatic pancreatic cancer were treated. Patients were 18 years of age and older with no locally invasive disease and had not received prior chemotherapy for their metastatic disease. In the Phase I dose escalation portion of the study, ABRAXANE (100, 125, or 150 mg/m2) in combination with gemcitabine (1,000 mg/m2) was administered weekly for three weeks (on days one, eight and 15) with one week of rest. The primary safety endpoint for the study was the identification of the maximum tolerated dose of the ABRAXANE and gemcitabine combinations studied, while the secondary safety endpoint was the incidence of treatment-related adverse events (AEs) and serious adverse events (SAEs). Efficacy endpoints included evaluations of confirmed response rates (complete or partial responses by RECIST criteria), stable disease for 16 weeks or longer, progression-free-survival (PFS), overall survival (OS) and disease progression (PD).
Investigator-assessed responses were determined via CT scans using RECIST criteria. An additional independent radiological review was conducted via PET scans using EORTC criteria as well as CT scans using RECIST criteria. Results from the independent radiological review demonstrated:
- A disease control rate of 60 percent according to PET scans using EORTC criteria. Complete responses were observed in 13 percent of patients and 44 percent of patients achieved a partial response. Two percent of patients experienced stable disease for 16 weeks or longer.
- A disease control rate (confirmed complete and partial responses and stable disease for 16 weeks or longer) of 78 percent according to CT scans using RECIST criteria. Partial responses were observed for 40 percent of patients and 37 percent had stable disease for 16 weeks or longer.
Secondary analyses assessing the correlation between SPARC status and change in another tumor biomarker, CA 19-9, were also conducted. Sixty-one of the 67 patients were evaluated for response using RECIST criteria by the investigators and 45 patients were evaluated for response using PET scans.
Results showed that of the 54 patients with elevated CA 19-9 levels at baseline, a decrease of 50 percent or greater was observed in 78 percent of patients over the course of the study; this decrease correlated strongly with response rate, PFS and OS. A response rate of 57 percent was observed in patients with a greater than 50 percent decrease in CA 19-9 levels (n= 42) and PFS and OS for these patients were 8.7 and 12.3 months, respectively. By contrast, patients with less than a 50 percent decrease (n=12) experienced a response rate of 17 percent and PFS and OS of 3.6 and 6.2 months, respectively.
The ABRAXANE 125 mg/m2 plus gemcitabine 1,000 mg/m2 arm was identified as the maximum tolerated dose. In this treatment arm, the most common grade 3 and 4 adverse event that occurred in more than 20 percent of patients was neutropenia; grade 3 events occurred in 14 patients (36 percent) and grade 4 events occurred in nine patients (23 percent). Grade 3 sensory neuropathy and fatigue and grade 3 and 4 thrombocytopenia were also observed. One combination-associated death due to sepsis occurred in a patient receiving ABRAXANE 150 mg/m2.
SPARC, an albumin-binding protein is often found in the most aggressive metastatic tumor types, including breast, lung, prostate, melanoma, and pancreatic cancers. Clinical studies have shown that the presence of SPARC is often associated with a poor prognosis for patients.ii Recent research suggests a potential role for SPARC as a target for the development of anti-cancer agents. iii
Enrollment is ongoing in a Phase III study that will evaluate ABRAXANE plus gemcitabine versus gemcitabine alone as a first line therapy for advanced metastatic pancreatic cancer.
About ABRAXANE®
ABRAXANE is a solvent-free chemotherapy treatment option for metastatic breast cancer which was developed using Abraxis BioScience's proprietary nab® technology platform. This protein-bound chemotherapy agent combines paclitaxel with albumin, a naturally-occurring human protein. By wrapping the albumin around the active drug, ABRAXANE can be administered to patients at higher doses, delivering higher concentrations of paclitaxel to the tumor site than solvent-based paclitaxel. Nab-paclitaxel is currently in various stages of investigation for the treatment of the following cancers: expanded applications for metastatic breast, non-small cell lung, malignant melanoma, pancreatic, gastric and head and neck.
The U.S. Food and Drug Administration approved ABRAXANE for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in January 2005 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. For the full prescribing information for ABRAXANE please visit www.abraxane.com.
About Abraxis BioScience, Inc.
Abraxis BioScience is a fully integrated global biotechnology company dedicated to the discovery, development and delivery of next-generation therapeutics and core technologies that offer patients safer and more effective treatments for cancer and other critical illnesses. The company's portfolio includes the world's first and only protein-bound nanoparticle chemotherapeutic compound (ABRAXANE®), which is based on the company's proprietary tumor targeting technology known as the nab® platform. The first FDA approved product to use this nab platform, ABRAXANE, was launched in 2005 for the treatment of metastatic breast cancer and is now approved in 36 countries. The company continues to expand the nab platform through a robust clinical program and deep product pipeline. Abraxis trades on the NASDAQ Global Market under the symbol ABII. For more information about the company and its products, please visit www.abraxisbio.com.
i American Cancer Society. Cancer Facts & Figures 2009. Atlanta: American Cancer Society; 2009. Available at http://www.cancer.org/docroot/STT/STT_0.asp.
ii Podhajcer et al. 2008. Cancer Metastasis Rev. 27, 691-705.
iii Neil Desai, Vuong Trieu, Bruno Damascelli, Patrick Soon-Shiong. SPARC Expression Correlates with Tumor Response to Albumin-Bound Paclitaxel in Head and Neck Cancer Patients. Translational Oncology. June 2009, Volume 2, Number 2, 59–64.
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