Logo

Servier Presents Updated P-I Study Results of Tibsovo (ivosidenib) for IDH1-Mutated Relapsed/Refractory Myelodysplastic Syndromes at EHA 2023

Share this
Servier

Servier Presents Updated P-I Study Results of Tibsovo (ivosidenib) for IDH1-Mutated Relapsed/Refractory Myelodysplastic Syndromes at EHA 2023

Shots:

  • 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

Related News:- Servier’s Tibsovo (ivosidenib) Receives EC’s Approval for IDH1-Mutated Acute Myeloid Leukemia and IDH1-Mutated Cholangiocarcinoma

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com

Click here to­ read the full press release 

Neha Madan

Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions