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ASH 2024 | Assessing a 4-weekly dosing schedule of mogamulizumab in pts with mycosis fungoides/Sézary syndrome
Christiane Querfeld, MD, PhD, City of Hope, Duarte, CA, comments on the preliminary results of a Phase II study (NCT04745234) assessing the efficacy of a 4-weekly dosing schedule of mogamulizumab in patients with relapsed/refractory (R/R) mycosis fungoides/Sézary syndrome, types of cutaneous T-cell lymphoma (CTCL). The agent has shown a manageable safety profile and promising response rates with this dosing schedule. Dr Querfeld also provides insight into mogamolizumab-associated rash (MAR), an adverse event that occurred in a subset of treated patients. 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 I’m very excited to present the data here on behalf of my colleagues. So mogamolizumab is approved for CTCL, but with the first month given weekly, and then the second month and every subsequent month given bimonthly. So this is a different approach. This is basically giving monthly with a higher dose. It’s higher than each single dose. And so 33 patients from centers in Europe and in the United States were included...
So I’m very excited to present the data here on behalf of my colleagues. So mogamolizumab is approved for CTCL, but with the first month given weekly, and then the second month and every subsequent month given bimonthly. So this is a different approach. This is basically giving monthly with a higher dose. It’s higher than each single dose. And so 33 patients from centers in Europe and in the United States were included. And so excitingly, we actually had, among those patients, 12 patients who had responded. And in those patients, there were two patients with complete response and 10 patients with partial response. So those responses are similar to the Phase III trial Maverick that has led to the approval. So that’s very reassuring that even in the monthly dosing, it’s highly effective.
Then today I’m also presenting the correlative markers, the biomarkers that were taken, particularly the evidence of MAR, its Mogamolizumab-associated rash. So a subset of patients developed that. So interestingly, so we see in the treatment, so within the first cycle or first two cycles, see a really rapid decrease in the CD4/CD8 ratio and also actually regaining of CD7 so that’s very reassuring that the treatment works. Analysis was done in skin and blood. Then we also looked into markers for immune cell activation and actually that’s quite promising that actually mogamolizumab in this dosing can actually increase certain tumor-infiltrating cells and certain markers for immune activation.
We also actually analyzed when the drug or the drug eruption or the Mogamolizumab-associated rash occurred. So the signature is distinct, particularly the inflammatory signatures, inflammatory cell signatures, such as inflammatory macrophages, which is I think will help to delineate the rash and the nature of the rash. So it’s not just a pure drug eruption. So this is in essence, so I’m hoping everyone else finds the data exciting too.
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Disclosures
Helsinn: Membership on an entity’s Board of Directors or advisory committees, Research Funding; Citius Pharm: Membership on an entity’s Board of Directors or advisory committees; SIRPant: Other: clinical investigator ; Kyowa Kirin: Honoraria, Membership on an entity’s Board of Directors or advisory committees, Other: Clinical investigator, Research Funding.
