Video
Positive Loncastuximab & Rituximab Results in R/R Follicular Lymphoma | Juan Alderuccio, MD | #ASH24
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• December 23, 2024
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Dr. Juan Alderuccio from the Sylvester Comprehensive Cancer Center discusses an ongoing study of loncastuximab and rituximab in the treatment of relapsed/refractory patients with high-risk follicular lymphoma.

Transcript
My name is Juan Alderucho from University of Miami Silvestre Comprehensive Cancer Center in Miami, Florida, and I will be talking today about our clinical trial evaluating long-cast tuxima tesserine in combination with retuximab in patients with follicular lymphoma. In this clinical trial, we enrolled 39 patients with relapse or refractory follicular lymphoma in need of therapy based on a GELF criteria, which means that the patient has high disease tumor burden or progression of disease within 24 months after front-line therapy. It's important to measure that patients with POD 24 are associated with poor outcomes and there is no standard of care in this setting. So we conducted this clinical trial and provide long-cast tuximab for every 21 days and retuximab for weekly doses and subsequently one dose every eight weeks. The first response assessment was the week 12, which was the primary study endpoint, and we observed a CR rate of 67% with an overall response rate of 97%. And with that number, the study met its primary endpoint. And, however, there were some patients that the response improved at week 21 reassessment and the best overall response rate was 97% for a best CR rate of 77%. Importantly, the 12-month progression fee survival and overall survival were more than 90% with a not-reached median progression fee survival and overall survival. Regarding the safety profile, the most common toxicity was mainly grade 1, grade 2, and regarding grade 3 or higher was mainly neutropenia. There were a few cases of liver enzyme elevation, rash, and flu retention. If the patient developed flu retention, what was required was to provide diuretics like spinolactone and Lasix and in most of the patients that was enough to resolve this toxicity. Based on the encouraging single-center activity, this study has now transitioned to a multi-center study aiming to enroll 61 more patients for a total of 100 patients and that study has been already initiated in September. There is currently no standard of care in the second line or later of follicular lymphoma. A common option is the use of lenalinomide in combination with Rituximab or in third line or later the use of bi-specifix like Mosonutuzumab, Epcoritamab, or CAR T cell. The difference is this treatment is a shorter period of treatment and even in the dose expansion, we are further decreasing the length of therapy to six cycles. So it's a treatment that hopefully in a shorter period of time can produce higher responses. And comparing to lenalinomide with Rituximab, what we observe is a higher complete response rate what was previously described in the OMEN trial. We test lenalinomide with Rituximab and now where the goal of expanding the number of patients is to see better understand the efficacy and the safety in this population. So this trial will be open in the University of Miami health system, also in different sites in central and north Florida, in Michigan, in New Jersey, and in Pittsburgh. All the information is available in clinicaltrials.gov and where all the contact information of these centers is available in the website.

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