Thanks, Bill.
which little to treated. developing you today AML the I'd it to to we're follow what namely a tuspetinib, So on and describe about are the patients the said, context just bit is in like how landscape
therapy. So comorbidities elect received but some patients may occasions, form sort AML patients a of receive first of therapy rare majority newly likely of care, the diagnosed have many patient too some palliative line. for who would On in
of than tolerate patients individuals patients XX This a for receive a potential the rate. form intensive younger of and curing chemotherapy kind this if age subset to generally, has younger complete very remission and will therapy. enough The a are fit has of high they
plus lower past hypomethylating AML standard great intensity of However, majority the which candidates meaning of become not And with has instead, consisting venetoclax frontline years. in average about therapy patients the would high-intensity chemotherapy. for few age in is patients care that receive be may the the of XX, the agent, of
remission composite in a rate survival of a complete the achieving about had This complete X/X the form of months. complete recovery rate a setting of that therapy frontline XX% remission to median is includes patients remission XX complete overall XX%, about of mainly about some count and and
they remission, maintenance so and stem receive would of treatment. might happen an to be receive kind cell Now after can what allogeneic able transplant therapy, a achieve to they is individuals curative it's do potentially complete that after that ideally, therapy who candidate may
are therapy may for Alternatively, a in hopefully not complete maintenance deep a patient who they candidate achieved alone no a transplant remission as or is stem therapy cell remission. receive
be still have patients patients immediately And However, can in in a disease never remission remission and refractory is initial treatment, yet relapsed they undergo achieve and outcomes relapse and quite they complete have to or a even considered are refractory cases dismal. therapeutic what and transplant therapeutically we primarily may who refractory some consider may meaning failure. achieved or
therapy important patients really best a words, refractory that make in to it happen longer this in And relapsed therefore, likelihood improve doesn't disease to it remain is In to other the try with the sure because that place. first is try frontline treat to prevent remission way the to outcome. for
it for to standard as older upon the benefit for the we VIALE-A the I can do from the that break frontline has venetoclax we approval plus new of HMA subpopulations. intensive for chemotherapy in unfit induction of down unfit why different as that the treatment can still the individuals, or become So improve older led trial say HMA-VEN standard individuals
or greatest they NRAS in had have KRAS, FLTX mutations that a from or they genetic did therapy. of the have namely individuals this benefit TPXX, more kind not profile, Those favorable
In was over their survival median X fact, overall years.
patients be have KRAS months. FLTX-ITD in category, the wasn't benefit risk might high some in mutations, half downstream some were with or their overall FLTX-ITD benefit survival NRAS individuals was or intermediate mutations and their XX namely those there about as good, even of median they do However, that only mutations
less was X/X was patients survival about benefit apparently, have the who than little outcomes. a months alone. addition patients over have there and Those X a the median then HMA The with mutation. of And of had venetoclax TPXX an worst overall
So and substantial that see in signaling mutations there proliferative or and with patients to improve that room have for upon KRAS in is the they venetoclax. HMA particularly improvement, outcomes an FLTX these NRAS these
is where think for we tuspetinib. I prime opportunity a have And that
that. drug?
We than a half AML succumbing So let's the of opportunities in patients talk the cases about XX,XXX that and about annually What the know disease each that to more the the year. is U.S. has disorder are for with
be option where individuals As are those is the majority a poor, overall I that relatively for still than older are to the common not age rates survival that chemotherapy where XX. survival age close is estimated X-year induction median XX%. of meaning is mentioned, especially less to patients and
but Now improvements a overall that XX-month CR/CRI have VEN-HMA subset outcomes. patients few the and last mentioned, frontline that a combination inferior median Dr. about of the mentioned Rice rate have I there have of X/X as response made survival for a years, are overall therapies in
is we X frontline HMA frontline We the successes with try to have remission that those there. combining novel seen are studies inhibitors XX% kinase agent agents, In composite and to improve promising. seen very have shown which and in rates a outcomes have several setting, in particular, complete to trials venetoclax, XX% patients. of
of of agent. hypomethylating agent, when give combined a Unfortunately, but standard tend have care they agent short for toxic of you that third that part, triplet be standard liabilities. requiring of to novel own the just the the in fall the care placebo of their of dose instead venetoclax, and to a the reductions not meaning they combined backbone third In do of more agent, is therapy
they AML And trials are of other genetic a of of meaning applicable patients the broader targeted course, that defined to used only subset these by have many agents, either biomarkers. range not or
genetic improve to first-line So and of need there subtypes. a AML is all an patients triplet urgent safe outcomes more for for effective
So and a as it could third kinase low-intensity as chemotherapy intensive setting third favorable safety how be we the with with drive be combined done the have approved in fit frontline been does venetoclax that into very have the in with ideal treatment both profile a for model other combined tuspetinib in agent inhibitors could as agent or HMA option. an
frontline This, patients broad to other have steps are I patient think, we opportunity therapy where triplet a chosen applicable an there frontline as first setting and those this no approved low-intensity the on in for provides population. tuspetinib our drugs as for currently focus
to that allows will require standard remission arms patients reduce and such of dose a clinical give arm. reduction for permit, with both that them to rates care. in so the standard potentially a treatment care of Doing us FLTX complete a example, study in having survival of the placebo-controlled doesn't to increase of randomized would This without the way mutations
we aware, is includes agent wild patients of that or As developed AML this majority a of represents course. the combination only in without biomarker, with are patients, as which the type far generally VEN-HMA patients FLTX being mutational
patients NRAS the KRAS therapy with it's bring frontline TPXX, for and safer the to that with the on hope be safety broadly will other a table. triplet that that based triplets profile only this We in paradigm. might date to combination that patients unfit And tuspetinib-venetoclax-HMA additional toxicities the agent includes mutations
is landscape the agent, ideal I to agent. for and expressed talk why a about having for AML tuspetinib So want third rationale the of an
mutant combined HMA they've and and mentioned, with flip complete substantially remission drugs have venetoclax gilteritinib rate boosted the the been we population. like in As
the proof is class this drug So of that principle of advances. make important there can
dose But the reductions. the we that limitations have mentioned seen required I that
we've we've profile has agent think, extensive these ideal date a that and I as the from other drug. clinical learned frontline with make third setting, that to to this tuspetinib, generated in data Now agents it might the an superior
combination prolongation We've monotherapy impair not could its with with does tells damage in interruption related and where a achieved clinical muscle done that who in without tuspetinib extensive that side the tuspetinib as to in syndrome, differentiation tuspetinib that of drug, several counts. or the blood continue prolonged QTC no testing, myelosuppression both maintain remission and us with further of venetoclax remission have patients to patients including development, even take effects evidence their drug
there patients, drug large see dramatic relapsed setting significant require now the interactions doses. agent of we in that established in venetoclax with it combining By dose refractory changes would a developing their number either of that understand aren't or them at
course, patients, the multi-kinase as and that have unmutated which inhibit really pathway activity substantially other drug agents agents FLTX there. importantly, the tuspetinib responses in of can And patients of other that to like perhaps the other prior-FLTX the of do, we agents differentiates that see as because believe we inhibitors gilteritinib. comparisons in don't proportion seen we -- from of have can large demonstrated we we out responses We need with direct, have in favorable we a with see
that studies suppressing profile, potentially superior them are even potentially VEN-resistance targeting where alleviate Importantly, other mechanisms more we may resensitize by to resistance mechanisms be VEN the help and prevent potential able or may arising. we of that oncogenic from on resistance based have preclinical pathways safety
all the agents. Therefore, strong to a combining VEN-naive where there patients believe tuspetinib rationale with in are like is particularly setting, venetoclax frontline we for
what So get have to we there? done
both treated drug select large show of that the completed safety demonstrated exploration without we've single of a mutations, as drug single We've demonstrated with and profile a we populations patients context. the activity that dose a FLTX in agent we've where agent superior the in you, I'll the of and number
safety it without safely learned plus agents. the of the could about and of given dose how be tuspetinib is venetoclax, In the substantial we've doublet characterized modification, study CPK both
drug. protocol now FLTX in designation put to to this fast and has triplet FDA achieved position patients in where mutations orphan status us a drug with we've This submit also the track and a for
TRIPLE implemented will later to would placebo-controlled that sites Tuspetinib of to this we study. registrational dosing the being a to prepared of enroll other enable our dose us now So first the agents, of and allow study already pilot optimal the care been standard the which randomized clinical maintain select patients year. and are has hope then
learn to mitigate of safely will characterize combinations We how as difficult that drug And mutations, give likely kinds in treat TPXX FLTX have these or the benefit and to mutations. several to we'll well best about those myelosuppression. as activity mutations less patients of subgroups NRAS-KRAS
and on safety establish before efficacy we characterize steps. CPK and at having take impact profile be We'll and further survival might what our finally, we overall the the next look
just spend to X mixes going of actually these together, compares little out this are a giving time want agent drugs how be and to are bit how there. sharing to that I we other
intensive to For XX% the activity about the be an kind wild-type mutation, first that FLTX that group, chemotherapy, in prevent look These the for pilot because in XX of both have the earlier. to in understanding I those just either of more age shoot or that of therapy having FLTX described we're older, a all ineligible study, proposing XX the to other of FLTX or comorbidities and would patients factors total. mutant over triplet frontline so setting, our XX at we because about patients treat for induction that going are patients we'll and are
and the as top The as is addition together to together by standard with the in way daily care of shown ASA a tuspetinib we're of drugs , giving going here. give VEN doublet the graph
is this to XX consistent begin venetoclax biopsy will day that will see bone XX, a you cycle. on per venetoclax that and for we remission, perform days that with if achieved have suggests hold patients and XX label, marrow XX You can day at starting the
to the patients long making takes necessary. adjustments so, how counts monitor if then do to We along recover the and it will way, allow
to they if see through a for they with course, a time the XX, a bone if to would tuspetinib move to patient formed additional when recovery they to second occur blood biopsy achieved along remission. before continue have, a if they allow will day be achieved take their cycle. then has And second count Of venetoclax on then not remission, the the marrow
cycle cycle. second would to according be made drugs Patients the myelosuppression significant adjustments as the label. based adjusted will to the their on have a of experience same in second dosing the the first. The VEN-ASA with cycle who do no type have receive on patient's to go Those that will
So milestones data. to are now let's talk about we have when and likely
up coming in So very agent Madrid. will really Navar we our Dr. present will and given doublet our presentation providing along Daver. these of shortly ASH meeting what we in lines the data, EHA an update to be at earlier single by presented oral the There, summary
meeting, treatment worth population hopefully, the presentation San end the to for triplet we that enrollment Meeting our after Hematology end study. Society this have our continued the This frontline in Diego of near several And will of of here the -- Annual Shortly the approval. at expect patient data first begin frontline in in at patient with QX. patients' of
the The as more meet meeting multiple hope for data additional the with trial EHA summary the and will along for regulatory in we FDA milestones we XXXX. a at have next continue, mature course, way. and of steps adding with prepare to year's
the some the us that about to go front doublet of proceed line. So that -- I'll some data and frontline the data understanding into monotherapy gave of in briefly how
drug-related elevation safety deaths. in achieved a prolongation in has the again, very and agent, single XX a clean CPK would tuspetinib now patients damage. muscle no a fact, And summarize, no agent to been of to in or be has monotherapy that had who given Tuspetinib drug-related single remission patients So with, myelosuppression discontinuations or it profile QTC as evidence over
can most adverse the adverse X Here, see related few the relatively nausea to frequent you larger of very with were events or mild fatigue patients events. related with percentage tuspetinib and and Grade
combined rates or similar new tuspetinib with venetoclax higher other very in with Similar adverse and arising doublet no rates of and profile myelosuppressive occurs events, the unexpected we of signals addition neutropenia safety what venetoclax-containing in a expected. with regimens, of expected we very be would as is for febrile line rates with markers would expect much venetoclax of than lower fact, the when neutropenia in
tuspetinib graph evidence reductions agent is here evidence that of as patients single agent. the shows of This bone in with treated activity. here marrow a blast And single
some bone see degree half more marrow You of that blast the can than of reduction. patients achieved
this you shown variety a are that occurred dose of can see in colors. by different levels the And dint
prior-FLTX And inhibitor The other a just that more inhibitors triangle. point a as reduction. patients likely, were that bone likely, are prior-FLTX patients not show if I a thing marked with can to out is would see that you red with marrow blast had
represented to any by graph, VEN-resistant However, likely black patients in triangles, are with the knowledge to far right less as of less the the other with prior monotherapy. that respond venetoclax, our therapy a patients shown consistent are practically
on triangles see even then significant tuspetinib those the that and For And relapsed now doublet again patients we left, half black on when than of combination performed can of saw and far blast venetoclax the and right that we the the in have reductions patients relapsed/refractory contrast blast treated the disease, with reason, venetoclax of to of the refractory of study more tuspetinib the in with receiving in patients. pretreated reductions the setting. figure graph, many showing more
the And who than likely once still status. inhibitor more in likely prior-FLTX patients mutation patients red their that indicating to right are more, of triangles multiple because with don't respond prior-FLTX
and on the of more pass thesis you -- some I'll for the milestones now we'll So about the talk drug. talk investment Payne, -- near-term Fletcher? to Fletcher
