Gaëlle Saint-Hilary, CEO, Statistical methodologist at Saryga, shared a post on LinkedIn about a paper she co-authored with colleagues published in ESMO Gastrointestinal Oncology:
“New publication!
Just published:
‘Quantitative benefit-risk assessment of data from the phase III ClarIDHy study of ivosidenib versus placebo in patients with mIDH1 cholangiocarcinoma’ in ESMO – European Society for Medical Oncology Gastrointestinal Oncology.
This paper presents a rigorous quantitative benefit-risk assessment of TIBSOVO (ivosidenib tablets), a drug developed by Servier, using structured expert elicitations for weights and scales, and recent methodologies including the Scale Loss Score (SLoS) – a method I was proud to develop with Pavel Mozgunov a few years ago.
The results showed a clear benefit for patients and were used as supportive evidence in regulatory submissions for ivosidenib – now approved by FDA and EMA.
Huge thanks to all co-authors for their collaboration and expertise: Juan Valle, Ghassan Abou-Alfa, Katie Kelley, Maeve Lowery, Rachna Shroff, Ying Bian, Hua Liu, Zhaoyang Teng, Camelia Gliser, Arndt Vogel, and Milind Javle.
And congratulations to Servier for bringing this innovative treatment to patients – a remarkable achievement in the fight against cholangiocarcinoma.”
Authors: Juan Valle, Ghassan Abou-Alfa, Katie Kelley, Maeve Lowery, Rachna Shroff, Ying Bian, Gaëlle Saint-Hilary, Hua Liu, Zhaoyang Teng, Camelia Gliser, Arndt Vogel, Milind Javle.
