— Our panel of specialists go over 3-year findings from the stage II ELARA research study
by
Greg LaubDirector, Video, MedPage Today
December 26, 2023
Clients with relapsed/refractory follicular lymphoma experience long lasting reactions when treated with tisagenlecleucel (tisa-cel, Kymriah) according to brand-new 3-year information from the stage II ELARA research study provided at the current American Society of Hematology (ASH) yearly conference
In this second of 4 special episodes, MedPage Today united 3 professional leaders in the field, all from The Ohio State University Wexner Medical Center in Columbus– mediator Kami J. Maddocks, MD is signed up with by Yazeed Y. Sawalha, MDand David A. Bond, MD — for a virtual roundtable conversation on the motivating follow-up information on the chimeric antigen receptor (CAR) T-cell treatment in this setting.
Following is a records of their remarks:
Maddocks: Let’s proceed to our next abstract. This abstract,”Scientific Outcomes of Patients with Relapse Refractory Follicular Lymphoma Treated with Tisa-Cel: Phase II ELARA 3-Year Follow-up” I believe where there’s presently 2 chimeric antigen receptor T-cell items authorized for relapsed/refractory follicular lymphoma, possibly you guys can comment on your experience with these and then this 3-year follow-up that was provided at ASH.
Bond: Yeah, I believe with the development of the bispecifics, CAR-T possibly in some methods is a bit eclipsed in follicular lymphoma, however I believe it’s still an essential choice for treatment for our clients. And like you stated, there’s 2 items that we have presently offered for follicular lymphoma; and of those 2, tisagenlecleucel– we see that has a lower rate of CRS [cytokine release syndrome] and tends to simply in basic be more bearable for clients that might have more comorbidities or be older. It has actually been a drug that I’ve utilized in practice currently for follicular lymphoma clients.
Therefore we got to see here updates from the ELARA research study, which was the essential research study that caused approval, and they had follow-up of over 3 years. I believe the mean follow-up was 37 months when it existed. You get a sense at least at that timeframe for how well the reactions hold up. And I believe what you see is that the reactions do, a minimum of for approximately half of clients, tend to appear to still exist at 3 years.
Beyond the 3 years, I believe we’re all excited to see with more follow-up if you begin to see more of a plateau. And I do not believe we can state that yet with simply the 3-year mean follow-up on this research study. You do see there were some clients up to 4 years that were still reacting and in remission. I believe we’re delighted to see even more out there.
I believe there was likewise intriguing analysis simply taking a look at the clients based upon whether they had POD24 [progression of disease within 24 months]since we understand those tend to be the clients that are harder to deal with in practice. It did look like a minimum of numerically there was a much shorter PFS [progression-free survival] for those clients, however still a few of the clients that had POD24 still had a resilient advantage. And there wasn’t a big distinction in between the 2 groups of clients. I do not believe that would always lead you to not utilize this treatment for those high-risk clients; in some methods, [it] was assuring that there’s effectiveness a minimum of for some individuals because high-risk classification.
Sawalha: Yeah, I concur. I believe this was an extremely high threat client population and average of 4 previous lines of treatment, high portion of clients with POD24 and double refractory illness. The results were actually impressive. And once again, with an extra year the CRs [complete responses] appeared to be resilient. I concur with you, David; I believe specifically in follicular lymphoma, we still have to wait longer till we possibly ideally one day we’ll state we’re treating clients with follicular lymphoma with these treatments in the regression setting.
Maddocks: Could either of you discuss the security of this item?
Sawalha: Yeah, I believe the security information was extremely motivating. The threat of grade 3 or 4 CRS was just 1%, 50% total had CRS, however primarily once again these were grade 1 or 2 occasions. The threat of neurotoxicity was low likewise in this client population. Total I would state beneficial threat. I would state one caution a bit is this is a more youthful client population. The average age is 57, there were clients up to the age of 73. Simply one thing to keep in mind.
Bond: Not your normal, [not] Always the very same clients that you’re seeing in center more typically with follicular lymphoma, however likewise a more high-risk subset. And I believe we have a great deal of experience with tisagenlecleucel as an item that was authorized early on for scattered big B-cell lymphoma. And I believe the security that we see in follicular lymphoma appears to hold up with what we’ve seen with scattered big B-cell where it tends to be a really bearable CAR T item.
Maddocks: Okay, terrific. Any other ideas on the existing function of CAR in follicular lymphoma?
Sawalha: I believe here in follicular lymphoma you can truly make a really, excellent case to attempt a bispecific anti before a CAR T-cell in the 3rd line, I believe it’s certainly a conversation with the client, the advantages and disadvantages of each method. I believe the results appear to be a bit much better with CAR T-cells, although this is clearly cross-trial contrast. There’s a great deal of restrictions and cautions with that. In an indolent illness, I believe clients’ benefit [and] security might be focused on in this setting. And I believe because method a bispecific antibody may have a benefit.
Bond: Yeah, I concur. I believe that a few of the benefit to CAR T of it being a one-time treatment is appealing to clients, however a few of the negative effects that you see tend to be long-term, consisting of the cytopenias that can continue some cases and in the B-cell aplasia and threat for infection. Which’s where I believe getting longer follow-up with mosunetuzumab [Lunsumio] is intriguing, however with that you still have an end to the time, although it’s a longer course of treatment. And I would state that comparing the 2, you still have a more beneficial negative effects profile with mosunetuzumab compared to CAR T.
I believe in practice I have actually been focusing on bispecifics, unless there’s an issue for changed illness where we understand that CAR T items are really effective with big B-cell lymphoma or a client maybe that’s advanced on previous bispecific antibody treatment.
Maddocks: I believe sequencing these representatives resembles an entire other conversation.