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New combo therapy study results from ASH

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New combo therapy study results from ASH

If you missed it, go back and read Sunday’s post about the almost miraculous new leukemia therapy, developed by researchers at the University of Pennsylvania.  Forget “Dreaming of a white Christmas.”  This immunotherapy blockbuster has me dreaming of a myeloma cure!

And before I get started today, I wanted to give a shout-out to Moffitt Cancer Center tech, Linda Garcia.  Linda drew blood for my labs on Friday.  She was both pleasant and professional.  And I didn’t feel a thing!  Thanks, Linda!

I promised continued “drips and drabs” from ASH over the next few weeks.  Let’s start today with data from a pair of combination studies I learned about while listening to oral presentations last weekend.

Keep in mind that results from several dozen combination studies were reported in Atlanta.  Comparing and contrasting their results isn’t easy as you can imagine.

The biggest challenge for me is most of these studies are ongoing and relatively new.  It will take years for clinicians and researchers to try and sort all of this out as they quest to identify one or two ideal therapy combinations for patients with different genetic risk profiles and/or resistance to one drug or another.

Even when I was new to all of this, four years ago covering my first ASH in New Orleans, I found these presentations easier to follow.  Focusing on one or maybe two drugs at a time makes it much easier to compare apples to apples.  Three, four or more drug therapy combinations makes this an infinitely more difficult task.

The second study I highlight below is a perfect example of this, where prednisone is substituted for dex, and pomalidomide is used in a Revlimid naive patient population, where here in the U.S. most patients have used Revlimid and not Thalomid.  It can all get very confusing!

I selected the following two studies not because they are necessarily any better than others.  I selected them because they are prime examples of the hard to compare mix-and-match challenge I just described.  They are two of over two dozen presentations I attended at ASH last week.

Mayo clinic docs have come-up with a new myeloma therapy combo: carfilzomib, cyclophosphamide, thalidomide, dexamethasone (CYCLONE).

The goal was to include carfilzomib with an established therapy combination without overlapping toxicities.  As I mentioned before while reviewing similar studies, I’m not going to focus on dosing, just Phase II progression free survival (PFS) and overall survival (OS) results when available.

Thanks to activists like Purdue researcher and myeloma survivor, Gary Blau, we should all understand by now how important dosing correctly can be–and how individual dosing could help improve our quality of life and improve results, too.

But I have no control over any of that.  I’m just a non-member and patient representative.  That doesn’t mean I’m not going to try and help advance this vitally important change.  But you can imagine how difficult it is going to be trying to change the way docs and researchers approach medicine!

So I’ll allow the experts to tweak when and how much of each drug is administered, hoping and assuming that they keep our (the patient’s) best interest in mind.

Back to CYCLONE.  Catchy name.  But does it work?

38 patients had a median age of 62.  These newly diagnosed patients achieved a 96% response rate.  Over 50% of the patients experienced low blood counts and a few developed measurable peripheral neuropathy (PN).  Several patients experienced serious heart issues or a blood clots.

VGPR or better was achieved in 71% of patients.  Researchers also chose this combination because it allows easy collection of stem cells.

My commentary:  Rev/dex or Velcade/dex can’t match these numbers alone.  But they aren’t too far off.  Key is depth of response–and closely watching what adding carfilzomib does to the mix.  This study is too young to be able to glean any of this information yet.

Does casting a wide therapy net like this increase PFS and/or OS?  Patients in a larger study will need to be following for a half dozen years to know for sure.  But I commend Mayo Clinic docs for trying to develop a therapy that is tolerable, effective and affordable.  Taking the time to give it a catchy name (CYCLONE) tells me they have great hope for this combination.

Moving on, lets take a look at a European combination approach.  Trying to improve on the traditional therapy of CyBor D, well known myeloma expert, Dr. Antonio Palumbo, presented European data, using pomalidomide, cyclophosphamide and prednisone (instead of dex).

55 relapsed and refractory patients completed at least one cycle in this Phase II Pom/Cytoxan/prednisone study (PCP).  25% were considered high risk.  85% of patients were refractory to Velcade.

Many European patients use thalidomide instead of Revlimid, so I always find it challenging to compare efficacy with U.S. studies, but here goes:

Overall response rate was 51%.  That’s a very good number.  BUT less than one half of patients were refractory to thalidomide, so what does that number really mean? It would have helped to have a majority–if not all–patients resistant to thalidomide, because I always focus on finding replacement drugs in a similar class.

Low-risk patients did slightly better than high-risk, but numbers were pretty close.  That is good news!

CR and VGPR rate was 24%.  Median PFS 10.4 months and one year OS was 69%.  These numbers are in line with other novel therapy combinations in relapsed/refractory patients, making this an option for patients that are ready to try pomalidomide

Stay tuned for news about a completely different type of therapy that uses a yet to be achieved 6th pathway to attack myeloma cells tomorrow or Wednesday.

Feel good and keep smiling!  Pat