On September 15, 2022 Mission Bio, Inc., the pioneer in high-throughput single-cell DNA analysis, reported new data supporting the use of its Tapestri Platform in clinical development, including clonal evolution patterns in patients with IDH1-mutated acute myeloid leukemia (AML) treated with Servier Pharmaceuticals’ TIBSOVO (ivosidenib tablets) plus azacitidine (Press release, Mission Bio, SEP 15, 2022, View Source [SID1234619603]). Data previously generated via single-cell DNA sequencing with Tapestri supported analyses for Servier’s ongoing pivotal phase 3 AGILE trial, the basis for U.S. Food and Drug Administration approval of the combination in newly diagnosed patients with IDH1-mutated AML in May 2022.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
AML is one of the most common and dangerous leukemias, as the majority of patients with AML eventually relapse after initial treatment – with poor prognoses. However, improving methods of molecular profiling has brought new hope by supporting the development and targeted use of precision therapies like TIBSOVO, the first FDA-approved IDH1 inhibitor. Researchers at Agios (later acquired by Servier) previously leveraged Tapestri to fully characterize the clonal architecture of AML at the single-cell level, revealing mechanisms of resistance to TIBSOVO monotherapy and enabling Servier to further explore the advantages of the combination therapy trial strategy.
Through their continuing collaboration, Servier has worked with Mission Bio’s Pharma Assay Development (PAD) services to utilize the Tapestri single-cell DNA sequencing technology to serially assess hundreds of samples from patients with IDH1-mutated AML who have been treated with TIBSOVO. At the World Clinical Biomarkers & CDx Summit this month, Servier will discuss Tapestri-powered findings revealing differences in the clonal evolution that occurs after TIBSOVO treatment in frontline and relapsed/refractory settings, both as a monotherapy and a combination therapy. This includes new insights into acquired resistance to TIBSOVO and azacitidine and the potential for serial molecular testing using single-cell analytics to enable physicians to dynamically sequence therapies to suppress emerging clones in AML.
"Targeted therapies play a key role in the continued evolution of precision cancer treatment, but it is critical to examine disease resistance in order to maximize the impact of these medicines," said Scott Daigle, Director of Translational Medicine at Servier. "Tapestri has shown that it can play an important role in helping drug developers discover insights that bring the right therapies to patients at the right time."
"The latest data on TIBSOVO, as well as the collaboration with Servier itself, is a great demonstration of Tapestri’s utility in retrospective studies. We are excited to see how this can potentially progress to prospective use of Tapestri in clinical trials for patient stratification, therapy monitoring, and measurable residual disease detection," said Todd Druley, Chief Medical Officer of Mission Bio. "Servier is again leading the pharmaceutical field, showing the potential for single-cell DNA sequencing to be used to predict relapse and help impact patient outcomes."
Servier is presenting a talk entitled "Clonal evolution underlying clinical responses and relapses in patients with IDH1-mutated AML treated with ivosidenib monotherapy or ivosidenib + azacitidine" at the 12th Annual World Clinical Biomarkers & CDx Summit at 4:15 p.m. on September 28th in Boston, Mass.
Visit Mission Bio during the World Clinical Biomarkers & CDx Summit from September 28-29 at booth 26.