Data for more than a dozen “new” myeloma drugs was presented at this week’s American Society of Hematology (ASH) meetings here in Orlando. As I described yesterday, several are hopeful crossover drugs; compounds that are already FDA approved for use against other cancers.
Like Imbruvica, many of these experimental drugs are looking for hopeful signs during early Stage 1/2 or 1 dosing trials. The FDA’s new Fast Track program allows companies to enroll fewer patients in their Phase 2 and 3 trials, making it cost effective to “throw an idea up against the wall and see if it sticks.” As long as a drug is deemed safe for a patient to take, more and more companies are giving it a shot.
There is so much money in myeloma drugs that companies are coming out of the woodwork to try and grab their share. And that’s fine. I say, “Bring ’em on!”
But (you knew that was coming) there are serious considerations. While enrolling in a trial and using one of these drugs may not hurt a patient, how much are they going to help; especially for late stage relapsed and refractory patients that are hoping for more time.
I’ve been following the progress of one such patient for months now. Traditional IMiDs and proteasome inhibitors weren’t helping anymore. And issues with her kidneys were tying the hands of her doctors. So the woman’s daughter, and Mayo Clinic specialist, helped quickly get her enrolled in a clinical trial for a drug called Selinexor, an experimental oral selective inhibitor that has shown a lot of activity against solid tumors.
Apparently someone at Mayo thinks this could really be a breakthrough. But I’ve heard that before. Predictably, the woman isn’t responding.
I write about this all the time. Until researchers crack the code that allows myeloma to become drug resistant, 100 different drugs aren’t going to help.
That’s what may set Darzalex (daratumumab) apart. If preliminary reports are true when combined with a number of other drugs, Darzalex amps up the depth and length of response; a primary reason why researchers, doctors and now patients are so encouraged that immunotherapies and/or biologics may eventually hold the key to overcoming drug resistance.
See, you can spin all of this a couple different ways. Hopeful, yet still so much for researchers to figure out. I must admit, things seem to be happening a lot faster than they used to. That helps keep me moving forward, even when I’m not feeling well.
Feel good and keep smiling! Pat