HGS, GSK Report Positive Results For Benlysta

Published: 02-Nov-2009

Benlysta met primary efficacy endpoint in two pivotal phase 3 trials, as specified by special protocol assessment agreement with FDA

Human Genome Sciences (HGS) and GlaxoSmithKline (GSK) reported that Benlysta (belimumab) met the primary endpoint in BLISS-76, the second of two pivotal phase 3 trials in seropositive patients with systemic lupus erythematosus (SLE).

The data from the BLISS-76 study were analysed after 52 weeks, in accord with the study protocol, in support of a potential biologics license application in the US and marketing authorisation applications in Europe and other regions. The study results showed that belimumab 10mg/kg plus standard of care achieved a significant improvement in patient response rate as measured by the SLE Responder Index at Week 52, compared with placebo plus standard of care. Study results also showed that belimumab was generally well tolerated.

Based on an intention-to-treat (ITT) analysis, belimumab 10mg/kg met its primary efficacy endpoint of superiority versus placebo at Week 52. A significant improvement was shown in patient response rate for belimumab 10 mg/kg plus standard of care, vs. placebo plus standard of care, as measured by the SLE Responder Index at Week 52: 43.2% for 10mg/kg belimumab, 40.6% for 1mg/kg belimumab, and 33.8% for placebo.

However, the 1mg/kg dose plus standard of care did not achieve statistically significant improvement in the current study. The SLE Responder Index defines patient response as an improvement in Selena Sledai score of 4 points or greater, with no clinically significant BILAG worsening and no clinically significant worsening in physician’s global assessment.

Results for prespecified major secondary efficacy endpoints showed that the proportion of patients with a reduction in Selena Sledai score of at least 4 points by Week 52, was 46.9% for belimumab 10 mg/kg, 42.8% for belimumab 1mg/kg, and 35.6% for placebo.

Improvement from baseline in physician’s global assessment (PGA) at Week 24 was not statistically different between the belimumab and placebo treatment groups. Mean improvement in PGA at Week 52, a prespecified although not a major secondary endpoint, was 0.49 for belimumab 10mg/kg, 0.55 for belimumab 1mg/kg, and 0.46 for placebo.

The BLISS-76 study is ongoing and will continue for 24 more weeks. Additional data will be available following completion of the full 76-week study period. Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. Belimumab is being developed by HGS and GSK under a co-development and commercialisation agreement entered into in August 2006.

Thomas Watkins, president and CEO at HGS, said: “The BLISS-76 results confirm our view that Benlysta has the potential to become the first new approved drug in decades for people living with systemic lupus. We take great pride in the innovation and scientific rigor that has made it possible to bring Benlysta to this point. We plan to submit marketing applications in the first half of 2010, following discussions with regulatory authorities in the US, Europe and other regions. We will continue to work with GSK to advance this drug to the market where it may benefit patients with significant need.”

Carlo Russo, senior vice president of biopharm development at GSK, said: “The results from this second pivotal phase 3 trial reinforce our belief that belimumab could deliver a significant therapeutic option for patients with lupus who have had no new treatment in fifty years. We look forward to continuing our collaboration with HGS in order to bring this important medicine to patients.”

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