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ICML 2025 | The Phase II VALYM study: valemetostat monotherapy in patients with R/R FL
Emmanuel Bachy, MD, PhD, Lyon Sud Hospital Center, Lyon, France, comments on the Phase II VALYM study (NCT04842877) exploring valemetostat monotherapy in patients with relapsed/refractory (R/R) follicular lymphoma (FL). Prof. Bachy reports that valemetostat is a well-tolerated, potent compound, with further studies investigating its use in combination strategies. This interview took place during the 18th International Conference on Malignant Lymphoma (18-ICML) in Lugano, Switzerland.
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Transcript
I presented data from the VALYM study, a specific cohort about follicular lymphoma patients in a relapsed refractory setting. As you may know valemetostat is a specific dual inhibitor of EZH1 and EZH2 compared to other inhibitors like tazemetostat which only inhibits EZH2. So it’s a very specific compound. It inhibits the trimethylation of the histone and it has been studied in various histologies and here we report specifically for the follicular lymphoma patient in the second line of treatment for after two systemic lines of treatment...
I presented data from the VALYM study, a specific cohort about follicular lymphoma patients in a relapsed refractory setting. As you may know valemetostat is a specific dual inhibitor of EZH1 and EZH2 compared to other inhibitors like tazemetostat which only inhibits EZH2. So it’s a very specific compound. It inhibits the trimethylation of the histone and it has been studied in various histologies and here we report specifically for the follicular lymphoma patient in the second line of treatment for after two systemic lines of treatment. So the patients were treated with 200 milligrams per day on a continuous cycle of 28 days and until progression. So in total 40 patients with follicular lymphoma were enrolled. They were 69 years old, immediately, so until 90 years old, so quite elderly people. And people were previously treated, some of them by stem cell transplants, some of them received CAR T-cells, most of them received lenalidomide, so heavily pretreated population. And the safety profile is really good. There’s only any grade GI toxicity with nausea, dysgeusia but virtually almost no grade three or more toxicity so very well tolerated a compound. And in terms of efficacy the overall response rate which is the primary endpoint of the study was 62% with 20% of complete response rate. The median duration of the response is 14 months and the median PFS is 9 months. Importantly, there doesn’t seem to be any difference between patients with EZH2 mutation or EZH2 wild type. There were 12 patients with EZH2 mutation and the response rate and the survival is similar between mutants and wild type populations. That’s really important because it’s different from what we have been observed with tazemetostat. So in conclusion, we can see that it’s a very well-tolerated compound, it’s very potent and there are further studies in combination with other strategies.
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