AAN 2026 | Phase III HERCULES & GEMINI trials: tolebrutinib reduces disability progression in MS
Celia Oreja-Guevara, MD, PhD, University Hospital San Carlos, Madrid, Spain, presents findings from the Phase III HERCULES (NCT04411641) and GEMINI (NCT04410978, NCT04410991) trials evaluating the BTK inhibitor tolebrutinib in multiple sclerosis (MS). Results show a significant reduction in disease progression, alongside a generally favorable safety profile with stable hematologic parameters. This interview took place at the 78th American Academy of Neurology (AAN) Annual Meeting in Chicago, IL.
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Transcript
So the HERCULES and the GEMINI trials, they are trials with tolebrutinib. Tolebrutinib is a BTK inhibitor. It’s one of the new treatments to target microglia and to treat the progression. So that we have now a lot of information about what tolebrutinib is doing, the efficacy of tolebrutinib in the progression. And we have seen that in the HERCULES study, that is a significant value in the tolebrutinib group...
So the HERCULES and the GEMINI trials, they are trials with tolebrutinib. Tolebrutinib is a BTK inhibitor. It’s one of the new treatments to target microglia and to treat the progression. So that we have now a lot of information about what tolebrutinib is doing, the efficacy of tolebrutinib in the progression. And we have seen that in the HERCULES study, that is a significant value in the tolebrutinib group. And these patients, they have an improvement in the progression. And we can stop the progression in around one-third in patients treated with tolebrutinib in comparison with placebo. And the GEMINI is the relapsing MS trial with tolebrutinib. So that regarding this, because now we know the efficacy related to the progression, and the tolebrutinib can change, can stop, or can, I will say, can decrease the progression of the disease. Regarding the safety, we have looked at the blood parameters so that here in this poster we have presented that when we look at the leukocyte and the lymphocyte, all of them are in the normal range. They are not a lymphopenia, not a severe lymphopenia, of course. When we look at the platelets, because there was some comments or some reports in the past and with the platelets in general in all of them they are in the normal range there was only one patient in the HERCULES study in the arm of tolebrutinib that was he was with a thrombocytopenia and we have resolved very quickly and regarding the immunoglobulins, we see that the IgG levels are always stable. They are not a decrease. When we look at the IgM levels, there is a decrease of the IgM, but always over above the normal range. And regarding the monocytes, it’s the same. So the monocytes are in the normal range so that in conclusion all the hematological parameters in the blood are in the normal range and there was only a very mild decrease of the immunoglobulin IgM and they say there was no problem with the platelets.
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Disclosures
Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for roche. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving as a Consultant for merck. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for merck. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for roche. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for sanofi. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for novartis. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for viatris. Celia Oreja Guevara has received personal compensation in the range of $0-$499 for serving on a Speakers Bureau for biogen. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for bms. Celia Oreja Guevara has received personal compensation in the range of $500-$4,999 for serving on a Speakers Bureau for jannsen.
