reviewing next to data PKR accepted programs the start presentation and that abstracts. have at three from highlight excited ASH by ivosidenib important sets for Thanks been I IDH clinical David. I'm several our will month.
First, the featured in X updated relapsed an AML be and trial will oral presentation. clinical data from Phase refractory
for have ASH Phase These ivosidenib portions the CR+CRh to safety naive burden daily is trials from were dose our the deriving this XXX dose presentations. overall data objective prevent benefit dose formed of to in longer CR. and treated we data and and end-point the up AML preliminary full that in expansion more to combining NDA same efficacy the ivosidenib dose in Phase the validate single May refractory X is in The with escalation analysis and the and the With independence, seen an are All planned data X our patients demonstrate once agent patients minimum patients late X+X enasidenib our with the for studies setting. line for abstract advanced for IDH included focus pure of and and six data one or These enasidenib prior front is relapsed stage encouraging stands from using inhibitors H of The date. the continues XXX MDS the to May frontline At AML morning months follow or pleased additional data the significantly tolerability XXXX of where mutational VIDAZA establish full capture AML. on analysis data and terrible or was efforts ivosidenib outside have XXXX survival, or order are are efficacy and The patients IDHX to mutant XXX early data, planned at ivosidenib will data cutoff. also We you improvement hematological the of remissions presented existing both accepted consistent will transfusion cutoff. these A on efficacy patients with VIDAZA. submission. X+X treatment oral follow analysis combining been primary trial with Both patients. include core safety Phase the combined a trial. a clinical of up milligrams data the efficacy
we initiate the trial this to us X which the Phase combine with year earlier disclosed have to azacitidine dose hurdles comparing to ivosidenib we led alone. VIDAZA safety ivosidenib AGILE and VIDAZA cleared As full
combining a eligible in also and are year. update planning on next for for to We we ivosidenib X+X study early and induction the stages patients chemotherapy X study expect you that consolidation Phase of
to and week at and with Cholangiocarcinoma Cholangiocarcinoma a the data the IDHX morphologic increased an in ivosidenib setting was last AACR-NCI-EORTC appears changes treatment and survival. the progression patients in to I then ongoing of with now tumor presented be steps work for induces triple Translational Mutant free will solid on meeting. review our provide our data program. demonstrated in The ivosidenib next update Moving for Glioma Cholangiocarcinoma subset molecular associated
and studies. these findings of the future explore in further to clinical expect biological significance We
remains track open Phase sites to to X continued new in XXXX. study treated mutant additional complete on We and enroll a and trial patients IDHX clarity Cholangiocarcinoma. Enrolment into previously
and are to two designing showing decision step number have for this help potential you trial who of program, perioperative to have we to treatment to now radiation, Ivosidenib patients to relatively on this potential and a our chemotherapy mention are at Turning surgery, young on next is us this shortly. heard date will based we study the and a prior the is AG-XXX. Glioma, molecules in data the indication, on The Today age currently this I options. pivotal study conduct large a which have describe a indication an we diagnosed as where rely
presented and data the tissue triple animal preclinical were The XHG can in last molecule demonstrated models. week in suppress first at meeting the brain AG-XXX
As toxicity study. tumor mentioned we limiting the previously in observe we dose [ph] have phasal the AG-XXX with and solid
in a have expansion completed additional exploration dose have present selected XXXX. to plan We and X and We data dose Phase work bring forward. now to the
ivosidenib and demonstrated arm. is The of with non-enhancing imaging designed XX molecules. as updated surgery. study randomized further five patient Glioma to disease The plan IDH the the the focus to the conduct median patients meeting To tissue For subset approximately progressive effects year's by will that include well and longer XHG measured continues molecule ivosidenib with last confirm data An X month both grade ivosidenib SNO be tissue. meaningfully serve AG-XXX in will ivosidenib low to the grade increased a inhibition will their drug of we tissue. the and assess of brain, this The treated order including the window selection following tolerated study we we as will and patients or In this prior presented has with for profiles study data. with volume amount penetration follow-up magnitude of pivotal be Meeting disease. to objective, levels to target last four in Glioma tumor presented on epigenetic Glioma at will our engagement and additional low or weeks treatment duration Phase with trial to investigate determine the AG-XXX tumor a since in metric later Patients to in patients brain our Glioma of control either finalize in tumor and brain safety update. will be data at on to addition both on assess IDHX perioperative impact differentiation the population of
be details a to of our history next core we time. co-fund a from informed ASH. all In enrolled perioperative X initiate component will Boston will half complete that be cost ongoing provide the sharing poster presentation be Celgene in study work by will deficiency. at I We focus additional of us on this to will will ASH they Updated the Updated data AG-XXX progress now expect session the natural Celgene us study patients has study the regulatory seek Glioma. is design also XXXX XX follow-up the Hospital at month that the for that in Phase pivotal ASH. that close trial by period not pyruvate year in input all development. patients. presented first and help for the dosing conducted will Children's six we'll kinase with at continues study. on conjunction in in also The additional the data primarily will PK dry reviewing
patient natural team clinical a clinical and of of of natural outcomes, burden. a the greater been enrolled history long-term chronic study fully anemia, variability history understanding our care, to deficiency With and develop of disease associated to including has implications pyruvate launch the preparing global treatments current kinase registry this
to be XXXX the pyruvate open registry half countries. years. deficiency at a the and set disease will In outcomes Adult will are in XX first be registry. sites kinase least XX of eligible in kinase for patient include for and and is addition patients followed approximately Pyruvate implemented reported pediatric will two
efforts We finalizing are the AG-XXX for patient recruitment global the protocols also and pivotal trial program.
you the turn financials. call I now initiated around over first of half these will Andrew with update once cover year. will the timelines additional to trials our in have details We to next