Yesterday I explained why my interview with Dr. Kauffman was so informal. Using a relaxed, conversational style allows me to get a feel for the moment. More than that, I can try to get a sense of how my subject really feels. Are the guarded? Or they hiding something? Are he or she genuinely enthusiastic and knowledgeable, or are they simply regurgitating pre-rehersed talking points?
I may not be an experienced interviewer, but I know people. Dr. Kauffman was genuine and unrehersed. He was also empathetic–applying the answer to nearly every question to my specific circumstances as a patient. Here is Part Two of our interview. My next question:
Can you explain how and where carfilzomib will be distributed and who will have access?
“Refractory, or therapy resistant, is a sub set of relapsed patients. We are hoping for as broad an approval as possible–one which includes both types of patients.”
Dr. Kauffman went on to explain: “Earlier, you asked about ‘off label use of a drug like carfilzomib.’ I can’t comment about this directly, but once approved, physicians should have a great deal of latitude as to how and where the drug is used.”
Writer’s Note: The novel therapy agent I take, Revlimid, has been used “off label” for over four years–meaning it has been prescribed to front line patients–even though it is still only approved for patients who have already had one or more myeloma therapies. The practical issue here is insurance reimbursement–will an insurance company pay for the use of a drug that has not been specifically approved by the FDA for that application.
Dr. Kauffman, what excites you most about this new novel therapy agent?
“I’m excited about a number of things. Three different things, in fact. First, our ongoing Phase 2 study results showing a fifty-five Percent Single-Agent Response Rate in Relapsed/Refractory Setting. This means over one half of patients who have relapsed and are failing their new treatments are responding to carfilzomib.”
He continued: “I would like to add that we are seing similar results in patients who are averaging five prior therapies to taking carfilzomib. So patients who have run out, or are running out of options are benefiting. And I might add, over twenty percent of those patients are refractory to Velcade (the only current FDA approved proteasome inhibitor).”
“I am also really happy to see how few patients invovled in our clinical studies are developing moderate to severe PN. And patients with existing PN coming into the studies are often not getting any worse!”
Dr. Kauffman’s final point: “I think our combination data is outstanding–some of the best results ever seen in myeloma related clinical trials.”
That’s saying a lot, considering the new combination trials of Vel/Rev/Dex are performing so well.
After making a few suggestions about how I might become involved in ongoing clinical trials–should I continue to become refractory to Revlimid–we said our goodby’s and Dr. Kauffman and his two person “entourage” left to cross the covered causeway back to the chaos and reality of meetings, research presentations and receptions.
I will conclude my three part interview series tomorrow with some follow-up and editorial comments.
Feel good and keep smiling! Pat