Singapore, Mar 19, 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 and Specialized Therapeutics Australia 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 Dr Mark Socinski, 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 companies noted that the data related to the study will be submitted for consideration as a late breaking presentation at the upcoming American Society of Clinical Oncology ASCO meeting.

Mr Carlo Montagner, CEO and founder of Specialised Therapeutics Australia 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. Subject to further data analysis, we anticipate filing to the TGA in 2011 for what will be the second indication for ABRAXANE in Australia,” he said.

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.

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).