COMUNICADO: Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Ery

 

COMUNICADO: Human Genome Sciences and GlaxoSmithKline Announce Positive Phase 3 Study Results for BENLYSTA(TM) in Systemic Lupus Ery

Actualizado 20/07/2009 8:03:34 CET

ROCKVILLE, Maryland and LONDON, July 20 /PRNewswire/ --

-- BENLYSTA (belimumab) met its primary efficacy endpoint by achieving a statistically significant improvement in patient response rate versus placebo in BLISS-52 -

-- First drug for lupus to reach this advanced stage of clinical development and achieve positive results, in the largest randomized placebo-controlled clinical trial ever completed in SLE patients -

Human Genome Sciences, Inc. (Nasdaq: HGSI) and GlaxoSmithKline PLC (GSK) today announced that BENLYSTA(TM) (belimumab, formerly LymphoStat-B(R)) met the primary endpoint in BLISS-52, the first of two pivotal Phase 3 trials in patients with serologically active systemic lupus erythematosus (SLE). In the placebo-controlled BLISS-52 study, the results showed that belimumab plus standard of care achieved a clinically and statistically significant improvement in patient response rate at Week 52, compared with standard of care alone. Study results also showed that belimumab was generally well tolerated, with adverse event rates comparable between belimumab and placebo treatment groups.

(Logo: http://www.newscom.com/cgi-bin/prnh/20080416/HGSLOGO)

"The BLISS-52 results demonstrated that BENLYSTA has the potential to become the first new approved drug in decades for people living with systemic lupus," said H. Thomas Watkins, President and Chief Executive Officer, HGS. "Given the limited treatment options currently available, patients would benefit greatly from potential new treatments. BENLYSTA is an outstanding example of the type of treatment HGS is working to develop and bring to patients. Assuming positive results in November from our second Phase 3 trial of BENLYSTA, we and GSK plan to submit marketing applications in the United States, Europe and other regions in the first half of 2010."

Belimumab is an investigational drug and the first in a new class of drugs called BLyS-specific inhibitors. No new drug for lupus has been approved by regulatory authorities in more than 50 years. Belimumab is being developed by HGS and GSK under a co-development and commercialization agreement entered into in August 2006.

"Lupus is a chronic, often debilitating, and sometimes fatal illness that affects an estimated five million people worldwide and can have a devastating effect on both patients living with the disease and their families," said Carlo Russo, M.D., Senior Vice President, Biopharm Development, GSK. "BENLYSTA is the first medicine being developed specifically for lupus that has reached this late stage of clinical development with positive results. We look forward to completing the pivotal studies, with the hope of bringing this potentially important therapeutic advance to patients suffering from SLE."

Key Findings from BLISS-52

"The BLISS-52 results support and extend the findings that emerged in the serologically active subgroup of SLE patients at Week 52 in our Phase 2 trial," said David C. Stump, M.D., Executive Vice President, Research and Development, HGS. "We are delighted to report that the efficacy of treatment with BENLYSTA plus standard of care was superior in this study to that of placebo plus standard of care, while the safety profile was comparable overall to placebo. BENLYSTA met the primary endpoint in this Phase 3 study at a robust level of statistical significance. BENLYSTA also significantly reduced SLE disease activity versus placebo based on a number of other measures, including SELENA SLEDAI and Physician's Global Assessment. Of note, a greater percentage of patients receiving BENLYSTA achieved a clinically meaningful reduction in steroid dose. We hope to have a full presentation of BLISS-52 results at an appropriate scientific meeting later in 2009."


Topline BLISS-52 results include:
-- Based on an intention-to-treat (ITT) analysis, belimumab met its
primary efficacy endpoint of superiority versus placebo at Week 52.
A clinically and statistically significant improvement was shown in
patient response rate for belimumab plus standard of care, vs.
placebo plus standard of care: 57.6% for 10 mg/kg belimumab, 51.7%
for 1 mg/kg belimumab, and 43.6% for placebo (p=0.0006 and p=0.011
for 10 mg/kg and 1 mg/kg belimumab, respectively vs. placebo).
Patient response was defined by an improvement in SELENA SLEDAI
score of 4 points or greater, no clinically significant BILAG
worsening, and no clinically significant worsening in Physician's
Global Assessment.
Results for each individual component of the patient response rate
were consistent with the overall improvement shown for the primary
endpoint.
-- Results for prespecified major secondary efficacy endpoints were:
-- A significantly greater percentage of patients receiving
belimumab achieved a reduction in SELENA SLEDAI score of at
least 4 points by Week 52, with 58.3% for 10 mg/kg belimumab,
53.% for 1 mg/kg belimumab, and 46.0% for placebo (p=0.0024 and
p=0.019 for 10 mg/kg and 1 mg/kg belimumab, respectively vs.
placebo).
-- Improvement in Physician's Global Assessment (PGA) at Week 24
was greatest in the belimumab 10 mg/kg treatment group versus
placebo (p=0.0003 for 10 mg/kg and p=0.27 for 1 mg/kg belimumab,
respectively) with improvement observed within 4-8 weeks.
-- A higher percentage of patients in both belimumab treatment
groups, versus placebo, had their average prednisone dose
reduced by at least 25% from baseline to 7.5 mg per day or less
during the last 12 weeks of study (p=0.053 for 10 mg/kg and
p=0.025 for 1 mg/kg belimumab, respectively vs. placebo).
-- Improvement in health-related quality of life at Week 24 as
measured by the SF-36 Physical Component Summary (PCS) score was
not significantly different among treatment groups. However,
although not a major secondary endpoint, improvement in the
SF-36 PCS score at Week 52 was significantly greater in both
belimumab treatment groups (p=0.025 for 10 mg/kg and p=0.027 for
1 mg/kg belimumab, respectively vs. placebo).
-- In BLISS-52, belimumab was generally well tolerated, with rates of
overall adverse events, serious adverse events, infections and
fatalities comparable between belimumab and placebo treatment
groups. Serious infections were reported in 5.9% of patients on
placebo and 6.1% of patients on belimumab. The most common adverse
events were headache, arthralgia, upper respiratory tract
infections, urinary tract infection and influenza, and were also
comparable between belimumab and placebo treatment groups. No
malignancies were reported.

Professor Sandra V. Navarra, M.D., a principal investigator and Head of Rheumatology at the University of Santo Tomas, Manila, The Philippines, said, "Given the limitations of available therapies, there is a great need for well tolerated and effective treatments for lupus. We are very encouraged by the findings of BLISS-52, and look forward to presenting these results later in the year. We also look forward to the results of BLISS-76 later this year."

About the BENLYSTA (belimumab) Phase 3 Development Program

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