Servier Presents Updated P-I Study Results of Tibsovo (ivosidenib) for IDH1-Mutated Relapsed/Refractory Myelodysplastic Syndromes at EHA 2023
- The P-I dose-escalation & expansion study evaluating Tibsovo as monotx. in 68 patients, showed a CR rate of (38.9%) & an ORR of (83.3%) in the efficacy analysis, the median time to CR was 1.87mos., the median duration of CR (was not reached) & the m-OS (35.7mos.) along with durable remission
- 66.7% &77.8% became independent of transfusions & maintained transfusion independence during any ≥56-day post-baseline period among 9 patients who were transfusion dependent with red blood cells or platelets at baseline
- TRAEs were consistent with the known safety profile of Tibsovo, TRAEs (42.1%) among 19 patients incl. in the safety analysis set. The company plans to submit a sNDA to the US FDA for r/r IDH1-mutated MDS, based on these results
Ref: PRNewswire | Image: Servier
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