Yesterday I set the stage for today’s report about research data which was featured at the International Myeloma Foundation’s Journalist Workshop Monday night.
My original intention was to share a lot of specific data and facts–nothing but the facts.
I plan to do just that–except for the “nothing but the facts” part. Because I think it is important to also share how I felt on what became–at least for me–an emotional roller-coaster ride Monday night.
So fasten your seat belts and climb on!
Dr. Durie opened the evening by providing us with a brief history of ASH. Apparently, the game changing year unfolded at ASH in 2001.
That was the year that both thalidomide and Velcade presented Phase 2 research results that would forever change the way multiple myeloma it treated.
Velcade (MLN341, since it still hadn’t been named back then) and thalidomide both showed positive progression free survival (PFS) results that were so good that hematologists wondered if they were real.
So 2001 was the year that novel therapy agents first became a reality. Over the next three or four years, data continued to impress–and overall survival (OS) numbers climbed.
Add Revlimid to the mix late in 2005 and you then had what I call the “Three Musketeers of multiple myeloma;” Thalomid, Velcade and Revlimid.
But if you think about it, there hasn’t been a new, truly effective multiple myeloma drug introduced since then.
All of the doctors sitting at the front of the room agreed that carfilzomib and pomalidomide will be the next two game changers.
Add the potential of using these new drugs in combination with the old drugs–along with improving the dosing and understanding of the Three Musketeers–and these docs were downright giddy!
COOL! So far, so good! Now let’s take a look at some specifics.
Professor Moreau seemed enthusiastic about a post-transplant Revlimid maintenance study.
307 patients used Rev/dex maintenance. 307 patients received placebo. Results were impressive: PFS was 46 months in the Rev/dex group and only 28 months in the placebo group.
But there’s a big catch. There was NO overall survival benefit (OS) at this point. Dr. Durie briefly addressed this by saying “It (overall survival) should improve with time.”
I buy that to a point. But once again, an otherwise promising study is torpedoed by lack of performance in the most important category.
Now a cynic might ask “why take maintenance meds if it doesn’t improve OS”…
For now, I’ll take Dr. Durie–and others–at their word that these numbers will improve as time goes on.
Let’s face it. Common sense tells us this must be true. But the stats are the stats. More about this tomorrow, because it comes-up again, tarnishing results from other important studies as well. I will also explain why Monday’s presentation was an emotional one for me.
Until then, feel good and keep smiling! Pat