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ASH 2025 | 12-month primary endpoint analysis from the Phase III ROP-ET study of ropeginterferon alfa-2b in ET
Jean-Jacques Kiladjian, MD, PhD, Saint-Louis Hospital & Paris Diderot University, Paris, France, discusses the 12-month primary endpoint analysis from the Phase III ROP-ET study (NCT06514807) of ropeginterferon alfa-2b in essential thrombocythemia (ET). Prof. Kiladjian notes that the treatment achieved durable responses and was well-tolerated. This interview took place at the 67th ASH Annual Meeting and Exposition, held in Orlando, FL.
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Transcript
We reported the primary analysis of the primary endpoint of the ROP-ET study. That was a study that enrolled patients with essential thrombocythemia in need of cytoreductive therapy, but intolerant, resistant, or who have ineligible for all available drugs in their own country. That includes hydroxyurea, anagrelide, busulfan, and pipobroma in some of the countries. And they were receiving ROPEG interferon-alpha-2b for 36 months...
We reported the primary analysis of the primary endpoint of the ROP-ET study. That was a study that enrolled patients with essential thrombocythemia in need of cytoreductive therapy, but intolerant, resistant, or who have ineligible for all available drugs in their own country. That includes hydroxyurea, anagrelide, busulfan, and pipobroma in some of the countries. And they were receiving ROPEG interferon-alpha-2b for 36 months. And the primary endpoint was to see the number of durable responses at 12 months, meaning that this was a composite endpoint, including not only complete hematological response, meaning platelets below 400,000 and leukocytes below 10,000, but also absence of disease progression, absence of vascular events, and also improvement in symptoms as measured by the MPN-SAF total symptom score. So the study met its primary endpoint at 12 months with 48% of patients achieving this composite endpoint with a durable response and if we look at the details of each of these criteria included in the primary endpoint for example in terms of complete hematological response the rate was 65% of the patients who had normal counts at 12 months. And also none of them showed disease progression. There were only two major vascular events that makes less than 2%. That’s very nice, I think. And also what was interesting is that the tolerance was very good. Indeed, the study design started at a low dose, 125 micrograms every two weeks, and patients could increase the dose in case of no response after three months to 250, and after six months to 500 micrograms. But indeed, 36% of the patients remained on the starting low dose until 12 months and achieved a durable response and with that low dose indeed we saw very few adverse events. Treatment-related adverse events for example we have seen only one patient had a treatment-related serious adverse event that was neutropenia and thrombocytopenia so that’s very good tolerance.
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