Mixed results for Sirtex in a trial involving its SIR-Spheres Y-90 resin microspheres.
In the trial involving 360 patients, SIR-Spheres Y-90 resin microspheres did not meet the primary endpoint of overall survival (OS) in hepatocellular carcinoma (primary liver cancer or HCC).
Median survival in the Y-90 resin microspheres arm was 8.84 months versus 10.02 months for arm comprised of patients administered Bayer's NEXAVAR (sorafenib).
However, according to the company, the analysis does not take into account that more than a quarter of the patients (28.6 per cen) scheduled to received Y-90 therapy did not receive treatment.
"If you look at the survival data based solely on those patients who actually received Y-90 resin microspheres, median OS was 11.3 months compared to 10.4 months for those treated with sorafenib, an opposite trend that is also not statistically significant,” said the company.
“The comparative data on side effects reported in the SIRveNIB study unequivocally favoured Y-90 resin microspheres over sorafenib," said principal investigator, Professor Pierce Chow, senior consultant surgeon, National Cancer Centre Singapore and the Singapore General Hospital.
The company also said secondary endpoints also favoured patients actually treated with SIR-Spheres Y-90 resin microspheres, including progression-free survival and overall time to progression.