I have been following the development of mavrilimumab, a human granulocyte-macrophage colony-stimulating factor receptor-α (GM–CSFR-α) monoclonal antibody, for a while now …
At the ACR 2015 meeting two studies on mavrilimumab were presented. The study by A.C. Bay-Jensen and colleagues is on a novel biomarker of macrophage activity called vicm. Interesting, but won’t get mavrilimumab much further on the way to approval.
G. Burmester presented an open label extension of the EARTH EXPLORER 1 and 2 (NCT01715896) phase IIb studies. In the conclusion the authors state: “Mavrilimumab continues to demonstrate a sustained efficacy and safety profile in pts with moderate to severe RA, over the 74 week treatment duration reported.”
So, what keeps mavrilimumab from approval. Still no phase 3 study and still no data on inhibiting radiographic progression. My guess is, that we have to wait for 104 weeks data to be published. But I have been sceptical and as time passes on and on, I grow even more sceptical that we’ll see mavrilimumab on the market.
And we haven’t heard anything about MOR103, another human granulocyte-macrophage colony-stimulating factor receptor-α (GM–CSFR-α) monoclonal antibody. Appearance at the ACR 2012 Meeting in Washington as a late breaking poster.
I would like this concept working, as we lack biologics with alternative modes of action, but I’m still not convinced. I hope that this will change next year.
Studies presented at the ACR 2015 Meeting in San Francisco:
Bay-Jensen AC, Guo X, Mortensen JH, Karsdal MA, White W. Vicm Is a Novel Biomarker of Macrophage Activity Evaluated in a Phase IIb Clinical Trial of Mavrilimumab [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/vicm-is-a-novel-biomarker-of-macrophage-activity-evaluated-in-a-phase-iib-clinical-trial-of-mavrilimumab/. Accessed November 10, 2015.
Burmester G, McInnes I, Kremer J, Miranda P, Vencovský J, Godwood A, Albulescu M, Close D, Weinblatt M. Long-term Safety and Efficacy of Mavrilimumab, a Fully Human Granulocyte-Macrophage Colony-Stimulating Factor Receptor-α (GM–CSFR-α) Monoclonal Antibody, in Patients with Rheumatoid Arthritis (RA) [abstract]. Arthritis Rheumatol. 2015; 67 (suppl 10). http://acrabstracts.org/abstract/long-term-safety-and-efficacy-of-mavrilimumab-a-fully-human-granulocyte-macrophage-colony-stimulating-factor-receptor-gmcsfr-monoclonal-antibody-in-patients-with-rheumatoid/. Accessed November 10, 2015.