Abraxane Meets Primary Endpoint In Phase 3 Trial For Advanced Non-Small Cell Lung Cancer
ABRAXANE®, Carboplatin Combination Demonstrated Superiority to Taxol, Carboplatin in 1st Line Non-Small Cell Lung Cancer
LOS ANGELES and MELBOURNE – March 18, 2010 – An international lung cancer trial has shown positive results in those patients treated with leading breast cancer drug ABRAXANE® in combination with carboplatin.
Biopharmaceutical companies Abraxis Bioscience Inc (NASDAQ: ABII) and Specialised Therapeutics Australia Pty Ltd (STA) announced that the extensive trial, at 102 sites globally including Australia, which enrolled 1052 patients suffering advanced non small cell lung cancer (NSCLC), met its primary efficacy endpoint as assessed by an independent radiologist review.
Researchers found those patients treated with ABRAXANE® and carboplatin demonstrated a significant improvement in overall tumour response rate compared with patients treated with a standard chemotherapy formulation containing TAXOL and carboplatin.
The Phase 3 trial was led by principal investigator Mark Socinski, M.D., at the University of North Carolina Lineberger Comprehensive Cancer Center, and is recognised as one of the largest NSCLC clinical studies to be conducted.
"This is exciting news for lung cancer patients and has important implications not only in late stage cancer but also in earlier stags of the disease," Socinkski said.
Professor Michael Boyer of Royal Prince Alfred Hospital, Sydney, was the Australian lead investigator.
The data will be submitted for consideration as a late breaking presentation at the upcoming American Society of Clinical Oncology ASCO meeting.
CEO and founder of Specialised Therapeutics Australia Mr Carlo Montagner said this was positive news for the many Australians who continue to be affected by this disease.
"We are extremely pleased with the results from this Phase 3 study, which included several Australian treatment sites, showing the superiority of ABRAXANE® over a commonly used drug combination in Australia,” he said.
“Subject to further data analysis, we anticipate filing to the TGA in 2011 for what will be the second indication for ABRAXANE® in Australia.”
NSCLC is the most common form of lung cancer, accounting for approximately 85% of all lung cancer cases.
National lung cancer statistics indicate it is the fourth most commonly diagnosed cancer in Australia, with 8249 new cases annually. 1
Patients in the study were randomized in two treatment arms: patients in Arm A received ABRAXANE® 100 mg/m2 weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle; and patients in Arm B received Taxol 200 mg/m2 weekly plus carboplatin AUC 6 on Day 1 of a three-week treatment cycle. The primary study endpoint was independently-assessed tumor response rate, as defined by RECIST criteria. Secondary study endpoints included: safety and tolerability; disease control rate and duration of response; progression-free survival (PFS); patient survival; and assessments of ABRAXANE® efficacy correlated with specific tumor biomarkers, including secreted protein acidic and rich in cysteine (SPARC).
In Australia, ABRAXANE® is currently approved and listed on the PBS for the treatment of metastatic breast cancer after failure of prior therapy, which includes an anthracycline.
ABRAXANE® is approved for metastatic breast cancer in over 35 countries including the U.S., Canada, European Union and China, and more than 60,000 cancer patients have received ABRAXANE® therapy in the past five years.
Additionally, ABRAXANE® is currently under Phase III investigation for the treatment of the following cancers: non-small cell lung, malignant melanoma, and metastatic pancreatic.
ABRAXANE® is a solvent-free, nanoparticle chemotherapy treatment option for metastatic breast cancer1. Developed using Abraxis BioScience's proprietary nabTM technology platform, ABRAXANE® is a nanoparticle protein-bound chemotherapy agent. ABRAXANE® combines paclitaxel with albumin, a naturally-occurring human protein, to deliver the drug and eliminate the need for solvents in the administration process. Nanoparticle technology allows ABRAXANE® to deliver a 49% higher dose compared to regular solvent-based paclitaxel without compromising safety and tolerability2,3.
In a randomised Phase III study of metastatic breast cancer patients, ABRAXANE® demonstrated nearly double the overall tumour response rate compared to solvent-based paclitaxel3. Anthracycline pre-treated patients lived significantly longer3.
The tolerability with ABRAXANE® and solvent-based paclitaxel was comparable, despite the 49% greater dose of paclitaxel administered as ABRAXANE®. Neutropenia was lower with ABRAXANE® compared to solvent-based paclitaxel, although there was an increase in incidence of grade 3 peripheral neuropathy with ABRAXANE®. However the median time to improvement, from grade 3 peripheral neuropathy to grade 2 or lower, was 22 days. No adverse events were reported that were not already known for paclitaxel.
Contraindications and side effects2:
Like all medications, ABRAXANE® may cause side effects.
ABRAXANE® should not be used in patients who have baseline neutrophil counts of <1.5 x 109 /L.
In patients who have exhibited hypersensitivity reactions to paclitaxel or albumin, patients should not be treated with ABRAXANE®. ABRAXANE® is contraindicated during pregnancy and lactation.
Most common side effects (≥1/10) caused by ABRAXANE® include; neutropenia, anemia, leucopenia, thrombocytopenia, lymphophenia, anorexia, peripheral neuropathy, hypoaesthesia, paraethesia, nausea, diarrhoea, vomiting, constipation, stomatitis, alopecia, rash, arthralgia, myalgia, fatigue, asthenia, pyrexia.
For further information regarding ABRAXANE® and potential side effects, physicians should review the ABRAXANE® Product Information and patients should consult their oncologist or the ABRAXANE® Consumer Medicine Information available on www.specialisedtherapeutics.com.au.
About Specialised Therapeutics, Pty Ltd
Specialised Therapeutics Australia Pty Ltd (STA) was established to identify, develop and commercialise innovative anti-cancer and other specialised therapies for the Australasian market. ABRAXANE® is the first of such therapies. Based in Melbourne, Australia, the privately held company is currently developing several more important therapeutic agents for release in Australia and New Zealand.
1. AIHW (Australian Institute of Health and Welfare) Incidence and prevalence of chronic diseases 2006
2. ABRAXANE® Product Information
3. Gradishar WJ et al. J Clinical Oncology 2005;23:7794-7803
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Posted: March 2010