Kevin Brigle:
There was a pretty extensive list of posters at the conference this year, 131 in total. It's really nice to see that aspect of JADPRO Live grow every year. A couple caught my interest. One was a patient advocacy poster from University of Cincinnati. they actually looked at the impact of the Bag It program on patients with newly diagnosed cancers. Bag It is a non-profit cancer organization that seeks to basically educate patients with a new diagnosis of cancer. When patients are diagnosed with cancer, they face a myriad of new difficulties, including uncertainty, inability probably to express themselves to their providers, and they have a host of both emotional and physical issues as well. They often have a difficult time finding where to find information so that we can adequately address some of these issues. Bag It collects information from a variety of cancer organizations, and they put this all in one bag. It's essentially a toolkit for patients to help them better communicate with their providers and to better cope with their disease in both the physical and emotional way.
The contents of the kit are actually cancer nonspecific, but they do have some cancer-specific bags. if you're really interested, you can go on the Bag It website and look at those. They started this program in 2019, and then it continues through today. So far, they've given this Bag It to approximately 400 patients. To assess the value of these bags to the patients, they sent out surveys asking whether, A, were you better organized? Were you better able to communicate with your provider? Were you better able to cope with your disease? Eighty percent of patients answered the positive in all of those categories. They then asked the same question of the patient's providers. Did you feel that the patients were better able to communicate with you and cope? They did that in 2019 when the program was new, and again in 2023. Eighty to 90% of providers in both years felt that their patients were better served by the contents of the Bag It.
The real take-home message is that this is really an important and easily obtained education service for patients to be able to obtain these Bag Its and give them to them. It can keep them better informed, and very importantly, help them communicate with their providers better as well. They also point out that this past year, they've actually developed a Spanish language Bag It in addition to help bring this to underserved populations.
The second clinical poster which caught my interest, and mainly because I work in hemalignancy and also with patients with multiple myeloma, is a poster out of the University of Colorado looking at managing MGUS or monoclonal gammopathy undetermined significance in a virtual pathway. MGUS is a pre-malignant plasma cell disorder, which can progress to myeloma, amyloidosis, to Waldenstrom's, macroglobulinemia, and other non-Hodgkin's lymphoma.
The actual risk of progressing to any of those other disorders is really based upon a couple of things, one being the subtype of the monoclonal band which is identified, and also the actual value of some of the abnormal proteins. Once you have those values, you can then risk stratify patients and determine whether they can just be followed routinely with labs or whether they need more extensive testing, which might include a bone marrow biopsy or a PET scan. Now, MGUS is pretty common. It's most commonly identified in the community which then elicits a referral to a cancer specialist. In Colorado, it's very rural, a lot of patients who are identified with MGUS are not near a cancer center. The University of Colorado set up a program where they could evaluate and manage these patients virtually using a nurse navigator and a nurse practitioner. They have a pathway with set labs that are necessary to risk stratify patients. Once the referral comes in, the nurse navigator looks to see if those results are available, if they're not, communicates back to the provider. If additional studies are necessary, those are referred back then as well.
Once all the data are present, this information then goes to the APP who sets up a virtual visit with the patient. If the patient actually is diagnosed with myeloma or a lymphoma, the patient will then actually come in and see the medical provider instead of a virtual visit. So in the first year of this program, they saw 23 patients. The majority of those patients turned out to be just MGUS, which is exactly what you'd expect. But they did identify two patients with smoldering myeloma and another patient with lymphoma as well. This program really shows the value of APPs in telehealth, especially here with MGUS, and the ability to get those patients in to see a provider in an expedient way and manage the actual disorder itself. What it also does is it prevents patients from having to come to the oncology clinic, patients who may not be able to, so it increases their satisfaction, decreases their cost, and importantly, it increases the satisfaction of the referring provider as well, because that provider can often have difficulty accessing cancer care in an expedient way.
And then finally, I think the one poster, which is really an encore poster just presented in September at the International Myeloma Society meetings, was an evaluation of the CEPHEUS trial. In this trial, they were looking at the combination of daratumumab, lenalidomide, bortezomib, and dexamethasone in transplant-ineligible patients or patients who want to defer transplant. Now, daratumumab as part of either triplet or as part of a quad is really the standard of care and the upfront treatment of myeloma. In the PERSEUS trial, the combination of daratumumab, bortezomib, lenalidomide, and dexamethasone was shown to be superior to the triplet of just bortezomib, lenalidomide, and dexamethasone. We saw increased progression-free survival. We saw deeper responses. Importantly, we saw greater MRD, or minimal residual disease, negativity in those patients treated with daratumumab. The importance of the MRD negativity is that it correlates positively with both progression-free survival and overall survival.
The FDA now accepts MRD negativity as a surrogate marker for overall survival. In the MAIA study which looked at transplant-ineligible patients, daratumumab in combination with lenalidomide and dexamethasone was shown to be superior to lenalidomide and dexamethasone alone. In fact, it really set a new benchmark standard with median overall survival in those patients of 7.5 years. So, the question then became would a quad, again the daratumumab, lenalidomide, bortezomib, dexamethasone, regimen improve outcomes in patients who were transplant-ineligible, much like it did in the transplant-eligible population. In that study, the combination was tested against again, the triplet bortezomib, lenalidomide, and dexamethasone. Both arms received eight cycles, then they went into maintenance. The primary endpoint was complete response in MRD negativity. The study did hit its primary endpoint that it was looking for. Sixty-one percent of patients were MRD negative in the dara-containing arm compared to only 39% of patients in the triplet.
If we just look at progression-free survival, you had a 43% less risk of dying or progressing in the daratumumab-containing arm compared to the triplet. What about side effects, though? If we're adding another drug, are there going to be greater complications? The answer is really no. If we look at adverse events, total adverse events, it was roughly 63% in both arms. The adverse events, grade three, grade four, which occurred greater in the daratumumab-containing arm, would've been neutropenia, thrombocytopenia, anemia, and pneumonia.
But in spite of that, the actual discontinuation rate in the daratumumab-containing arm was only 7%, whereas just in the triplet alone, with just three drugs, it was roughly 16%, so a lesser discontinuation rate with more drugs added in there as well. From that point, the study really concludes that this quadruplet combination we know is effective in the transplant-eligible population, so it has the potential to improve outcomes in the transplant-ineligible population as well. From an APP standpoint, again, this really goes to the importance of us staying abreast of clinical trials and NCCN guidelines so that we can offer our patients the most up-to-date and efficacious and safe treatment.
