Secondary endpoints failure take shine off Benlysta
pharmafile | April 21, 2010 | News story | Sales and Marketing | GSK, HGS, Lupus
GlaxoSmithKline’s lupus treatment has failed to reach a statistically significant secondary endpoint in the second of two phase III trials.
The first in a new class called BLyS-specific inhibitors, Benlysta (belimumab) is aimed at patients with systemic lupus erythematosus (SLE), a chronic, life-threatening autoimmune disease.
Benlysta has already met its primary endpoint in BLISS-76 on seropositive patients with SLE: a 10 mg/kg dose plus standard of care achieved a “statistically significant improvement” over 52 weeks in patient response compared with placebo plus standard
The drug generated excitement in July last year when drug’s first phase III results surprised analysts, showiing significant improvement in symptoms in SLE patients compared to placebo.
But at the end of BLISS-76, belimumab plus standard of care showed higher response rates compared with placebo plus standard – but this difference did not reach statistical significance.
The investigational monoclonal antibody is being developed by GSK and Human Genome Sciences (HGS) as part of a deal signed in 2006.
And HGS chief executive H. Thomas Watkins insisted the trials showed a “positive overall picture”.
“We view the results of these studies as strongly supportive of our view that Benlysta has the potential to become the first new approved drug in more than 50 years for people living with systemic lupus,” he added.
There has been a low success rate in the therapy area, with Biogen Idec and Roche’s Rituxan a high profile late-stage failure.
SLE is one of a number of forms of lupus, a disease which affects around five million people worldwide with symptoms including fatigue, painful and swollen joints, fever, skin rash and kidney problems.
Around 90% of lupus patients are female, especially between the ages of 15 and 45, and particularly in black, Asian and Hispanic populations.
Results showed that the drug is generally well tolerated, with overall adverse event rates comparable between Benlysta and placebo treatment groups.
“We and GSK are working together to complete and submit regulatory applications for belimumab in the United States and Europe in the second quarter of this year,” said David Stump, HGS executive vice president of R&D.
“We look forward to the full presentation of BLISS-76 52-week and 76-week results at appropriate scientific meetings later this year.”
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