29 Oct 2012, BioSpectrum Bureau , BioSpectrum
Singapore: Specialised Therapeutics Australia (STA) is going to publish abstracts related to its phase III metastatic melanoma study with Abraxane (nanoparticle albumin-bound paclitaxel) at the upcoming Society for Melanoma Research meeting. In the randomized, open-label, international study (CA033), Abraxane showed a statistically significant improvement in progression-free survival (PFS) in chemotherapy-naïve patients with metastatic melanoma as compared to patients receiving dacarbazine chemotherapy.
An interim analysis of overall survival, the secondary endpoint, shows a trend in favour of the Abraxane arm as compared to treatment with dacarbazine. Seventy Australian patients were involved in this trial of Abraxane comparing it with current standard chemotherapy agent dacarbazine.
"Metastatic melanoma presents significant treatment challenges due in part to limited therapies, low survival rates at diagnosis and no advances in chemotherapy in thirty-seven years," said Dr Evan M Hersh, lead principal investigator and professor of medicine, University of Arizona College of Medicine and Arizona Cancer Center. "Despite advances with targeted treatment and immunotherapies, there is still a need for new agents including chemotherapy treatments for the majority of patients with metastatic melanoma. The results from this investigational study of nab-paclitaxel not only demonstrated statistically significant and clinically meaningful improvement in progression-free survival, but a positive trend in overall survival."
STA chief executive officer Mr. Carlo Montagner said the positive data paved the way for Australian melanoma patients with metastatic melanoma disease to access more effective treatment options. "Very few treatment options exist for this group of patients," Mr. Montagner said. "We are extremely pleased to demonstrate that Abraxane is capable of prolonging survival times for patients with metastatic melanoma and we hope to have Abraxane approved by the Therapeutic Goods Administration in Australia by 2014."
Abraxane is yet to be approved for the treatment of metastatic melanoma. Following TGA review and approval, STA will seek to have Abraxane included on the pharmaceutical benefits scheme (PBS) for reimbursement of Abraxane for chemotherapy-naïve patients with metastatic melanoma.