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.
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