ASCO Peer Review Supports the Benefits of SIR-Spheres Y-90 Resin Microspheres in the Liver

• SIRFLOX results confirmed as both statistically significant and clinically meaningful in the liver
• Anticipate first-line utilisation in metastatic colorectal cancer
• SIRFLOX study selected by ASCO as one of the “Best of ASCO” presentations

Sydney, Australia; 1st June 2015 – Sirtex Medical Limited (ASX:SRX) is pleased to announce that following the ASCO presentation and peer review process of the SIRFLOX study, the results have been well accepted by the medical oncology community. The feedback from Key Opinion Leaders (KOLs) has been positive, and to that extent Sirtex believes sales in first-line mCRC are achievable based on the strong results demonstrated in the liver.

Sirtex anticipates increased utilisation of SIR-Sphere Y-90 resin microspheres in the first-line setting will gain momentum over time. SIRFLOX is the first ever study with Level 1 evidence to show a liver-directed therapy in combination with systemic chemotherapy and a biologic agent produces a clinically meaningful and significant effect in the liver. Consequently, incorporation into clinical practice beyond the current salvage setting in mCRC is now a realistic possibility with continued education of the results to the medical oncology community.

“We are pleased with the outcome of the ASCO peer review process, which we believe will ultimately facilitate an increase in the utilisation of SIR-Spheres microspheres at an earlier stage of patient treatment. Accordingly, we will continue to implement our regulatory and reimbursement strategies, progress discussions with treatment guideline panels and seek further KOL endorsement of the SIRFLOX results. Meanwhile, our current salvage business continues to perform strongly,” commented Mr Gilman Wong, CEO of Sirtex Medical.

With a 7.9 month improvement in Progression-Free Survival (PFS), a 31% lower risk of progression (HR=0.69) and strong statistical significance (p=0.002) achieved in the liver, Associate Professor Peter Gibbs, co-principal investigator of the SIRFLOX study and Consultant Medical Oncologist, The Royal Melbourne Hospital said “This finding matters a great deal because the liver is almost invariably the organ where colorectal cancer spreads to first. While half the patients initially diagnosed with colorectal cancer survive thanks to surgical removal of the primary tumour before the disease has spread elsewhere in the body, liver metastases eventually cause the death of the majority of the remaining hundreds of thousands of patients each year whose tumours spread but are inoperable.”

Professor Eric Van Cutsem, MD PhD from the University of Leuven, Belgium and current European Organisation for Research and Treatment of Cancer (EORTC) board member said “The SIRFLOX study results provide robust Level 1 evidence for medical oncologists to incorporate in their daily clinical practice.”

ASCO has further indicated the potential clinical relevance of the SIRFLOX study by selecting it as a  “Best of ASCO” presentation being one of just 71 of the several thousand abstracts reviewed for this meeting. “Best of ASCO” papers may be discussed in an ongoing cascade of official follow-up presentations that national oncology leaders will deliver over the coming months to medical oncologists in their countries who were unable to attend the ASCO Congress in Chicago.