Disappointing trial result for Sirtex

Company News

Disappointing news for Australian company Sirtex Medical (ASX:SRX) with the results of its 459-patient SARAH study confirming no survival benefit from use of its SIR-Spheres Y-90 resin microspheres over Bayer's PBS-listed NEXAVAR (sorafenib).

In the trial, patients with advanced or inoperable Hepatocellular Carcinoma (HCC) who usually received one or two treatments with liver-directed SIR-Spheres Y-90 resin microspheres had similar survival compared to patients who received standard twice-daily systemic treatment with NEXAVAR.

Sirtex said patients in the SIR-Spheres Y-90 resin microspheres arm experienced fewer severe treatment-related adverse effects and significantly better quality of life.

SIR-Spheres Y-90 resin microspheres is an approved treatment for inoperable liver tumours. It is a minimally-invasive treatment that delivers high doses of high-energy beta radiation directly to tumours.

“Neither sorafenib nor SIR-Spheres Y-90 resin microspheres produced a statistically significant difference in Overall Survival (OS) of the patients we studied,” said Professor Valérie Vilgrain MD, PhD, Department of Radiology, Beaujon Hospital, Assistance Publique – Hôpitaux de Paris and Université Paris Diderot, Sorbonne Paris Cité, France.

“Despite 26.6% of patients in the SIRT arm not receiving SIR-Spheres per protocol, the primary endpoint of Overall Survival by intention-to-treat [ITT] was not significantly different (median 8.0 vs. 9.9 months; p=0.18). Moreover, if we look at the patients who received SIR-Spheres or sorafenib according to the SARAH protocol, median OS was identical (9.9 vs. 9.9 months; p=0.92).”

Investors responded to the news with the company's share price falling 12 per cent on Monday.