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Data from phase II study to be presented at 45th Annual Meeting of the American Society of Clinical Oncology
45th Annual Meeting of the American Society of Clinical Oncology (ASCO)
Abraxis BioScience, Inc. (NASDAQ:ABII), a fully integrated biotechnology company, today announced results from a new ongoing study demonstrating anti-tumor activity for three dosing regimens of nab®-paclitaxel (ABRAXANE® for Injectable Suspension) (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) given in combination with bevacizumab in the first-line treatment of patients with metastatic breast cancer. The overall response rate for patients receiving a combination of weekly nab-paclitaxel (130 mg/m2) with twice weekly bevacizumab (10 mg/kg) was 46 percent. Patients who received a combination of nab-paclitaxel (260 mg/m2) with bevacizumab (10 mg/kg) plus filgrastim administered every two weeks and patients who received nab-paclitaxel (260 mg/m2) with bevacizumab (15 mg/kg) administered every three weeks had overall response rates of 39 percent and 44 percent, respectively. The safety profile was generally consistent with the known safety of nab-paclitaxel and of bevacizumab, although sensory neuropathy was limiting in the weekly nab-paclitaxel dosing arm suggesting a three week on treatment, one week off treatment regimen may be preferable.
Results also demonstrated a prolonged time to progression (9.0 months) among patients who received weekly nab-paclitaxel, compared to the every two and three week dosing regimens (6.3 months and 7.7 months, respectively). Overall survival data has not yet been established, and is currently being evaluated. Findings were discussed during an oral presentation (Abstract #1006) on June 1 at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held in Orlando, Fla.
"This study was initiated to expand on previous findings, such as the pivotal ECOG 2100 trial, demonstrating the benefit of Cremophor®-based paclitaxel given in combination with bevacizumab in the treatment of patients with advanced breast cancer," said study lead investigator Andrew D. Seidman, M.D., Attending Physician, Breast Cancer Medicine Service, Memorial Sloan-Kettering Cancer Center. "Further evaluation of nab-paclitaxel given weekly for three weeks followed by one week off treatment is ongoing in the CALGB 40502 trial. This Phase III study will help us better define a role for the combination of nab-paclitaxel and bevacizumab as a first-line treatment option for metastatic breast cancer."
Nab-paclitaxel is currently approved 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.
The open-label, Phase II study evaluated nab-paclitaxel in three dosing regimens in combination with bevacizumab, including:
* nab-paclitaxel (260 mg/m2) given every three weeks in combination with bevacizumab (15 mg/kg) every three weeks;
* nab-paclitaxel (260 mg/m2) given every two weeks in combination with bevacizumab (10 mg/kg) every two weeks plus filgrastim; and
* nab-paclitaxel (130 mg/m2) given every week for three weeks plus bevacizumab (10 mg/kg) given every two weeks.
About the Study
Randomized phase II trial of nanoparticle albumin-bound paclitaxel in three dosing schedules with bevacizumab as first-line therapy for HER2-negative metastatic breast cancer (MBC) (Abstract #1006)
In the randomized Phase II, open-label study, patients had HER-2 negative metastatic breast cancer and no prior chemotherapy treatment in the metastatic setting. The primary endpoints were safety and tolerability and overall response rate (defined as confirmed complete and partial responses according to RECIST criteria). Secondary study endpoints include time to progression and overall survival. Of the 209 patients randomized, 205 patients with similar patient demographics and baseline characteristics were treated. Seventy-three patients were treated with nab-paclitaxel in combination with bevacizumab every three weeks, 54 patients every two weeks (plus filgrastim) and 78 patients weekly. The majority of patients in all treatment arms had visceral disease (88 percent, 92 percent and 87 percent of patients for the three treatment arms, respectively) and received prior neoadjuvant or adjuvant chemotherapy (63 percent, 61 percent and 61 percent for the three treatment arms, respectively).
Overall, the combination of nab-paclitaxel and bevacizumab was well-tolerated and grade 2, 3 and 4 neurotoxicities were comparable across all three dosing regimens, with febrile neutropenia occurring in less than 2 percent of patients in all study arms. Grade 3-4 toxicities occurring in at least one patient in each treatment arm included: sensory neuropathy (30 percent for the nab-paclitaxel every three weeks arm, 48 percent for the nab-paclitaxel every two weeks arm and 40 percent for the weekly nab-paclitaxel arm); fatigue (15 percent, 30 percent and 14 percent for the three treatment arms, respectively); nausea (4 percent, 6 percent and 0 percent, respectively); and diarrhea (0 percent, 2 percent and 4 percent, respectively). Patients taking nab-paclitaxel (130 mg/m2) on a weekly dosing regimen in combination with bevacizumab (10 mg/kg) experienced significantly less grade 2-3 arthralgia, myalgia and nausea, compared to the every two and three week dosing regimens. The every two week dosing arm crossed an early stopping rule because of excess toxicity and was closed early. Results suggest a three week on treatment, one week off treatment regimen may be preferable.
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. ABRAXANE 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.
IMPORTANT SAFETY INFORMATION
The use of ABRAXANE has not been studied in patients with hepatic or renal dysfunction. In the randomized controlled trial, patients were excluded for baseline serum bilirubin >1.5 mg/dL or baseline serum creatinine >2 mg/dL.
ABRAXANE can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant while receiving treatment with ABRAXANE.
Men should be advised to not father a child while receiving treatment with ABRAXANE. It is recommended that nursing be discontinued when receiving ABRAXANE therapy. ABRAXANE contains albumin (human), a derivative of human blood.
Caution should be exercised when administering ABRAXANE concomitantly with known substrates or inhibitors of CYP2C8 and CYP3A4.
ABRAXANE therapy should not be administered to patients with metastatic breast cancer who have baseline neutrophil counts of less than 1,500 cells/mm3. It is recommended that frequent peripheral blood cell counts be performed on all patients receiving ABRAXANE. Patients should not be retreated with subsequent cycles of ABRAXANE until neutrophils recover to a level >1,500 cells/mm3 and platelets recover to a level >100,000 cells/mm3. In the case of severe neutropenia (<500 cells/mm3 for 7 days or more) during a course of ABRAXANE therapy, a dose reduction for subsequent courses is recommended. Sensory neuropathy occurs frequently with ABRAXANE.
If grade 3 sensory neuropathy develops, treatment should be withheld until resolution to grade 1 or 2 followed by a dose reduction for all subsequent courses of ABRAXANE. Severe cardiovascular events possibly related to single-agent ABRAXANE occurred in approximately 3% of patients in the randomized trial. These events included chest pain, cardiac arrest, supraventricular tachycardia, edema, thrombosis, pulmonary thromboembolism, pulmonary embolism, and hypertension.
In the randomized metastatic breast cancer study, the most important adverse events included alopecia (90%), neutropenia (all cases 80%; severe 9%), sensory neuropathy (any symptoms 71%; severe 10%), asthenia (any 47%; severe 8%), myalgia/arthralgia (any 44%; severe 8%), anemia (all 33%; severe 1%), infections (24%), nausea (any 30%; severe 3%), vomiting (any 18%; severe 4%), diarrhea (any 27%; severe <1%), and mucositis (any 7%; severe <1%).
Other adverse reactions have included ocular/visual disturbances (any 13%; severe 1%), fluid retention (any 10%; severe 0%), hepatic dysfunction (elevations in bilirubin 7%, alkaline phosphatase 36%, AST [SGOT] 39%), renal dysfunction (any 11%; severe 1%), thrombocytopenia (any 2%; severe <1%), hypersensitivity reactions (any 4%; severe 0%), cardiovascular reactions (severe 3%), and injection site reactions (<1%). During postmarketing surveillance, rare occurrences of severe hypersensitivity reactions have been reported with ABRAXANE.
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.
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