I remember well in 2015, we had monumental FDA approvals of Kyprolis in July, followed by Darzalex, Ninlaro and Elotuzumab in November (also known as the November to Remember!)

This year at ASH, each of these approved drugs continued to have new trials using them in a variety of combinations. I am impressed with Darzalex as it is effective against myeloma as a single agent drug (monotherapy) but works even better in combinations. Darzalex inhibits tumor cell growth. It is the first CD-38-targeted monoclonal antibody (mAB).

Daratumumab's mechanisms

In particular, this year at ASH, there was a presentation on Darzalex subcutaneous (Dara Sub-Q).  It shows significant results in Relapsed/Refractory Multiple Myeloma (RRMM).  Here are a few points that impressed me:

daratumumab infusion-related reactions IRRs

  • Dara Sub-Q enables dosing in 3-5 minutes
  • Adverse Events of Dara Sub-Q is consistent with Dara IV
  • Low infusion related reactions (IRR) incidence and severity with Dara Sub-Q
  • Well tolerated, rate of IRRs (infusion related reactions) was 12%; IRRs for Dara IV range between 45%-56% in RRMM
  • Clinical responses with Dara Sub-Q were observed, with rates similar to Dara IV

 

Recombinant Human HyaluronidaseThere are four ongoing phase 3 studies using Dara Sub-Q 1,800 mg.

We now have two very different drugs that fight myeloma from different mechanisms of action that are available by Sub-Q delivery in addition to IV:  Velcade (which is a proteasome inhibitor) and Darzalex (which is a monoclonal antibody)!  That’s good news for patients!

I would also like to mention that I was honored to speak at the IMF’s Patient Stories and Grant Awards Reception Saturday evening and a video blog (vlog) will be posted to this site soon.