It’s been a month since I last posted an update on progress in my trial of epcoritamab, a bispecific T cell engager (BiTE) for my chronic lymphocytic leukemia.
Since I last reported, my most recent MRI scans showed that essentially all my nodes are stable or still shrinking. All were normal sizes when imaged in December, and that is still the case. That, combined with a normal complete blood count and a low absolute lymphocyte count, means I remain in complete remission.
A month ago, I reported that I was uMRD-4 in the peripheral blood and planned to be checked down to one cell in a million (10-6) by ClonoSEQ, but there were missteps at the lab that hopefully will be remedied in time for my next blood draw in two weeks, so that result is still a ways off. The way I look at the delay means there is more time and more doses of the epcoritamab to rid me of any lingering CLL cells in my blood.
If my blood ClonoSEQ detects no cancer, then I guess a bone marrow biopsy is the next step to see how far down my cancer has been driven.
My next MRI is six months off, which is much better than having it every two months to start the trial. In April, my subcutaneous injections will be reduced to every four weeks instead of the biweekly schedule. It’s getting better all the time.
Time will tell how successful this new therapy will be.
I am still dealing with sore joints and muscles, though extensive stretching and three milligrams of boron seem to help (don’t take without your doctor’s okay). I still get a local itchy rash with the shots in my belly, but mostly my hospital visits and shots are nonevents.
On a personal note, I was invited to Washington, DC, to speak from the patient’s perspective on an FDA/AACR (US Food and Drug Administration/American Association for Cancer Research) panel about dosing in oncology phase 1 clinical trials. Over 4,500 attended online or live. I asked them to recognize that Phase 1 trials can’t do everything, and it is important not to delay the process in an attempt to squeeze out a little more early safety and efficacy data for dose optimization that might be better discovered in larger Phase 2 and 3 trials. Patients can be desperate for access to new therapies. There are lives in the balance. Don’t slow the process. And besides, one dose does not fit all. Why not move two possible doses forward to Phase 2? As is my usual MO, I had many questions and comments for the other panels, pushing for the best interest of patients, including allowing crossover in Phase 3 and intra-patient dose escalation in Phase 1 trials. I urged using more biomarkers in early-phase trials and encouraged patient-reported outcomes (PROs).
There is much work to be done to optimize trials for patients. I hope my voice and that of other patients were heard and listened to, not just there to “check the box.”
TRIALS ARE FOR PATIENTS, NOT THE OTHER WAY AROUND.
Time will tell how successful our advocacy will be in improving access, efficacy, and, of course, safety in clinical trials.
Brian Koffman MDCM (retired) MS Ed (he, him, his)
Co-founder, Executive VP and Chief Medical Officer
CLL Society, Inc.
5 Responses
So glad to hear you continue to do well. I continue he to be grateful for your guidance and the cll society. Best wishes.
Thanks so much Brian!! Good luck and keep fighting for yourself and the CLL community 😘😘
Love the advocacy in that forum, Brian! Glad you are doing well and fingers crossed for the uMRD results!
I am so hopeful this will be a most successful treatment for you! Your reporting on your experience in this trial is so helpful for the CLL community. We are all in your corner!
Chris
Very glad of the positive response and outcome!! Best of wishes!! And wanted to thank you many many times for your efforts in sharing information and communicating. One of the things that helps me the most is to have a feeling of empowerment towards the future and I get it through knowledge of treatment/medicine/trials in a great part through your videos and teachings!