Date: 2014-05-12
Type of information:
phase: 2b
Announcement: results
Company: AstraZeneca (UK)
Product: mavrilimumab
Action
mechanism: Mavrilimumab (formerly CAM-3001) is a first in class human monoclonal antibody that targets the alpha receptor for the cytokine granulocyte-macrophage colony-stimulating factor (GM-CSF). Through the targeted blockade of the receptor on the macrophage, a key cell in the pathogenesis of rheumatoid arthritis, mavrilimumab could add a significant new treatment option for RA patients.
Disease: rheumatoid arthritis
Therapeutic area: Autoimmune diseases – Inflammatory diseases - Rheumatic diseases
Country:
Trial details:
Latest
news: * On May 12, 2014, AstraZeneca announced that mavrilimumab met its primary endpoints in respective Phase II studies, demonstrating further pipeline progress in core therapeutic areas. Top-line results from the Phase IIb study of mavrilimumab, an investigational monoclonal antibody that inhibits a key pathway in the development of rheumatoid arthritis (RA), achieved its primary endpoints. In the Phase llb study of a methotrexate inadequate responder RA population (EARTH EXPLORER-1), 326 patients with moderate and severe RA were treated for six months with either mavrilimumab (low, medium or high dose) or placebo in addition to standard methotrexate background therapy. The co-primary endpoints of the American College of Rheumatology (ACR) response of ACR20 and Disease Activity Score (DAS28) were met with all mavrilimumab doses confirming the efficacy demonstrated in the previous Phase IIa study (EARTH). The high dose was the most effective with an ACR20 response at week 24 of 73.4 percent vs 24.7 percent for placebo (p<0.001) and a reduction in mean DAS28 score at day 85 of
-1.9 vs -0.68 for placebo (p<0.001). Additionally, all secondary endpoints including ACR50, ACR70 response and DAS28 remission score achieved statistical significance for the high dose. Mavrilimumab also produced rapid improvement in the multiple symptoms of rheumatoid arthritis and significant improvements in patient reported outcomes including disability, pain and fatigue. The safety findings observed were consistent with those previously reported for the Phase IIa study. The most commonly-reported adverse events (>3 percent) included headache, nasopharyngitis (common cold), hypertension, bronchitis and worsening of RA.
