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ASH 2024 | Longer follow-up of a Phase I trial combining golcadomide with rituximab in R/R DLBCL
Jean-Marie Michot, MD, Gustave Roussy Institute, Paris, France, comments on the results of a Phase I study evaluating the combination of golcadomide, a cereblon E3 ligase modulator (CELMoD), and rituximab in patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL). The study found a 48% overall response rate, including a 30% complete response rate, with durable responses observed in some patients who completed the two-year treatment period. This interview took place at the 66th ASH Annual Meeting and Exposition, held in San Diego, CA.
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Transcript (AI-generated)
So it was a Phase I study and we present at the ASH meeting a summary of and result of the part B of the study. So it was of course the first study with dose escalation and we find the dose in the part B of the study and we present the result of a cohort of patients with relapsed/refractory diffuse large B-cell lymphoma in combination with rituximab and golcadomide. And the patient was treated with golcadomide at dose 0...
So it was a Phase I study and we present at the ASH meeting a summary of and result of the part B of the study. So it was of course the first study with dose escalation and we find the dose in the part B of the study and we present the result of a cohort of patients with relapsed/refractory diffuse large B-cell lymphoma in combination with rituximab and golcadomide. And the patient was treated with golcadomide at dose 0.4 and 0.2 milligram. So it was something like expansion study as we found the dose 0.2 and 0.4. Treatment was given orally, golcadomide, two weeks on, two weeks off, in combination with rituximab weekly for the first cycle. And then at each day one of each cycle, day one of cycle two to five, and the full treatment, golcadomide, was scheduled for two years of treatment. So we enrolled in the cohort 77 patients. At the last point of cutoff for the analysis, 15 patients were still ongoing treatment, and the most reason for this continuation was progressive disease. The safety profile was characterized as scheduled by on-target adverse events, and the most frequent was neutropenia grade 3 for 46 percent of patients for 0.2 milligrams and 74 percent for the patients at 0.4 milligrams it’s on target expected adverse event and patients could be treated with G-CSF to control the neutropenia Other adverse events of interest were thrombocytopenia in 5% and 13% of patients for 0.2 and 0.4 mg respectively. And there were no significant other adverse events, non-hematological nature. And the activity for the whole cohort was 48% of overall response rate, including 30% of complete response. And we see response in CAR-T-naive and CAR-T-exposed patients. And interestingly, we found overall response rate, 50% for the CAR-T-exposed patients, including 33% of complete response. So it was interesting for the activity. We see, as you know, in the presentation, in ongoing patients, some patients completed the two years of treatment and kept the complete remission after the completion of the study protocol. So it was really interesting to see durable response.
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