Sirtex, a global life-sciences company that develops and delivers effective oncology treatments using novel small particle technology, reported the preliminary results of its SIRFLOX clinical study, which has been performed in Europe and Australia.
Based on the preliminary analysis just completed, the primary endpoint of the SIRFLOX study was not achieved. The preliminary analysis shows that adding SIR-Spheres(R) Y-90 resin microspheres to a current first-line systemic chemotherapy regimen for the treatment of non-resectable metastatic colorectal cancer (mCRC) does not result in a statistically significant improvement in the overall Progression-Free Survival (PFS). Overall PFS measures progression of existing tumours and/or the development of new tumours in any organ or body site.
Sirtex is pleased that the preliminary analysis showed that SIR-Spheres Y-90 resin microspheres did result in a statistically significant improvement in Progression-Free Survival (PFS) in the liver. This secondary study endpoint is important as liver tumours are commonly the only, or dominant, site of disease in patients with mCRC and are the major site of disease influencing survival. Up to 90% of mCRC patients die of liver failure due to the local effects of the liver tumours. SIR-Spheres Y-90 resin microspheres are specifically targeted to treat liver tumours.
As previously advised (most recently on 9th October 2014), the SIRFLOX study results and preliminary analysis still require verification and validation through the process of academic peer review. Presentation at a scientific conference and/or publication in a medical journal are essential parts of this process.
The final results and related detailed analysis of the SIRFLOX study will therefore be submitted to the American Society of Clinical Oncology (ASCO) Annual Meeting, which will be held 29th May – 2nd June 2015 in Chicago, Illinois.