good Thank and Bob, you, morning, everyone.
partnership Akeso. Bob Team Summit said, with enthusiastic of As I remain about the and accomplishments incredibly our
Before to or the work around that globally. with would Bob trials than ongoing in ivonescimab.
There clinical the XX tumor globe has conducted been completed, clinical across either highlights, ivonescimab X providing III more as some mentioned, like I XX China evaluating including on Phase settings, planned, or trials of discuss the are
in X the X III While cell announced evaluating our clinical been cancer. and are by cancer.
At solid have cancer, clinical we and are and sponsoring trials, Phase of currently HARMONi-X. tumor additional beyond candidate non-small non-small III lung Phase Summit, Summit includes lead neck ongoing head X BTC, programs cell cancer pancreatic lung HARMONi and Akeso focused settings trials III in Akeso, This across Phase
XXXX. metastatic moment, at in early planning speak to more and released a excited initiate lung are are development Summit-led exploring are that that we We on non-small to will beyond mentioned cell ESMO, HARMONi-X plan actively expanding cancer. clinical the Based was Bob I our it to in data
one action antibody ivonescimab targeting a licensed PD-X together highly and bispecific is Ivonescimab X PD-X novel simultaneously Phase territories. III only reminder, As molecule mechanism VEGF. brings these our VEGF in both into the in validated of
for as like the would completed remainder of year. as this review discussed, catalysts well the many to achievements some I upcoming Next,
a key the data progression both reduction trial response achieving clinically the of the from leading risk as in benefit of releases at of progression-free met compared Symposium tremendous featured conferences.
Last meaningful KOLs. patients as HARMONi-X a in HARMONi-X either squamous quarter across with Presidential was PD-LX pembro, consistent Consistent expressing PD-LX non-squamous and development part the XX% XXXX with received monotherapy, pembro. demonstrated Lung and primary of head-to-head World low disease an month events previous its or ESMO In catalyst histologies. high with The conference, showed September its in were moment Lung versus ivonescimab and for studies, safety with third to subgroups, landmark survival ivonescimab this the and at death results of World and and in Ivonescimab form ivonescimab or significant endpoint a tumors profile. ivonescimab including acceptable manageable comparing
expand we II beyond ivonescimab third been Phase the meaningful released lung With at Lung continue both that has with the various data solid cell non-small in to the tumor quarter World in generated additional and data ESMO, cancer. settings,
ongoing clinical in in partnership data licensed We have created territories. are own development we from fortunate our tumor studies, solid Summit's leverage collaboration a as Akeso, such strategy informing with to late-stage supporting multiple strong our and
wide will addition treatment its In Cancer touching inbound HARMONi-X from this tested in we yet past we on meaningful have and soon take and efforts to review to providing data range highlight regarding plans, Phase this tumor additional cancer results. clinical University opportunities to we expected quarter, settings, announced, alliances study from via begin not key proposed received in Akeso's trials, several study and or Patients updates to Texas the XX ivonescimab With designs II strategic approximately collaboration.
After wanted development opportunity clinical respective physicians of MD investigator-sponsored quarter this the interest a evaluate our and was we initiated begin Anderson which, our potential. types. the Center development soon are have current HARMONi-X of studies, to with further in ISTs, types the
trial with locally to pembro lung advanced start HARMONi-X monotherapy cancer, or Akeso HARMONi-X. in China. patients with positive expression. and conducted by multicenter sponsored III a Phase is will trial, randomized frontline double-blind a metastatic We non-small evaluating as ivonescimab with in PD-LX is single-region, compared This monotherapy clinical cell clinical
Our partners and analyzed at the in data HARMONi-X. generated Akeso
ivonescimab the the in PFS curves over months, a Here of arm. pembro significant was entire the duration first the begin committee X.X blinded ivonescimab of point by at of a months nearly interim of the far.
The with maintain observed median of hazard PFS survival at a XX.X for endpoint the control note, arms, first to all the XX% follow-up to ivonescimab X.XX, improvement Of the of thus separate X.XX reveals follow-up entire and for respectively. a the that analysis months study subgroups. radiographic demonstrating subgroups is of The primary separation with was time versus radiologic across over assessments and improvement PFS independent analysis, ratio benefit corresponding the median planned progression-free with review
for X.XX a patients for comparable expression. Specifically, the across the expression ratio tumors, and tumors expressing benefit X.XX PD-LX spectrum high quite hazard of with low patients of PD-LX with of with is PD-LX
benefit those and underscores strong the performance is a the for with that driven by that benefit tumors of also subgroups, of care monotherapy showed especially inhibitory is cell regard the favoring United not who across was overall ivonescimab, histology discussed, hazard lung a States favoring and histology, a hazard with in of of patients an PD-LX similar cancer lung high previously particularly cancer, standard slide the squamous ratio X.XX non-small patients X.XX expression.
With of indicator This As cell trial patients with the and ivonescimab. was for this non-squamous and is non-small was Europe, with checkpoint of to seen success clinical strong a true usage a ratio subgroup.
the to advanced adverse where squamous was of the risk, XX.X%. confirming historically in all by of a adverse AEs. rates are safety of not abnormalities, therapy lab-related safety, of of we treatment-related that are experienced proteinuria, higher translate event. more were leading to the held cell in often managing with general, its discontinuation as the tolerability randomized higher treatment-related rate a treatment-related in well, place dosing. has this evaluating the compared events nearly is comparable greater the numerically For true first in there ivonescimab III lung with In seen to especially of pattern in event serious pembro ivonescimab that hypertension arm. see advanced serious of but are population, we treatment-related discontinuation death, compared trial profile were anti-VEGF pembro Discontinuation this non-small and death in not were clinical who, treatment Phase oncologists demonstrated or events did and where cancer arm.
This squamous This This both safety numerically ivonescimab patients the lead higher detail, to that see which conditions generally did group. are XX.X% These rates there with
and possibly VEGF-related the to immune-related comparable the In Finally, pembro. see ivonescimab table with advanced events. AEs at we compared looking to left, immune-related the
ivonescimab in X VEGF-related possibly or and On more the with associated both right, we Grade AEs, see grades that, was higher. as expected, all
as advanced events classified most that either all however, or the Grade were bottom right Importantly, central in were X. patients and/or complications, VEGF-related and in cavitary no possibly blood There proteinuria all X advanced of There no represented including study.
The tumor III or cancer Grade table of squamous were this the threatening lung non-small possible that and encasing vessels X VEGF-related of shows hypertension. AEs Grade X bleeding AEs higher Grade the study. or in cell with among patients fatal is Phase large arm life evidence lesions in with tumors,
population. Phase survival plan non-small As PD-LX the in evaluating successful randomized pembro, cancer HARMONi-X analysis announced and monotherapy versus is frontline progression-free ivonescimab underlying endpoints, expressor our global and the study and of cell initiate survival. in primary our the HARMONi-X X high to lung data, planned a result with of overall study both we HARMONi-X their III
We patients XXX estimated in study. registration-enabling are for planning an this
patients histology, global non-squamous tumors III intend randomized as this HARMONi-X, to with amend trial Bob enroll mentioned, in patient. to include clinical to Phase addition continuing to of Turning we to squamous
providing lung cover survival. amendment, cancer trial As metastatic survival lung their X,XXX sample multi-regional updated patients will include adjusted driver has X most cancer, both broadened the in combination expressing to non-small squamous and a part quickly progression-free has with size primary total include HARMONi-X metastatic is III Phase non-small both squamous tumors cell the capture to Expanding estimated high for chemotherapy, of now overall II tumors, in without cover non-squamous as to efficient endpoint patients. endpoints all been to been intended cell both mutation.
HARMONi-X an The way with possible.
Supporting ivonescimab, is to the this the of trial clinical HARMONi-X, market that benefit to the now and of be this amendment, is opportunity to randomized primary as as showing and presented. significantly result via addressable intend cover as patients PD-LX tumors HARMONi-X and well Phase non-squamous part, previously monotherapy, data proposed
and the a clinical XXXX Conference for patients lung with combined the March first-line genomic trial This reminder, data advanced chemotherapy actionable non-squamous Cancer is cancer data from Akeso. updated AKXXX-XXX II metastatic in of European ivonescimab was alterations. and of patients centered in generated squamous was or Lung for treatment around without As the setting non-small at Phase which this analyzed announced cell in by cohort
XX.X patients advanced experienced tumors or of progression-free with months. survival First-line metastatic a non-squamous median
non-squamous X.X% advanced of and In leading in XX.X median survival Both not population, PD-X chemotherapy. events Median encouraging after to patients in of was median patients in addition, current experience reached ivonescimab XX.X% with of plus progression-free are of and this either patients overall of treatment-emergent XX.X first-line advanced follow-up or time expectation squamous a inhibitors tumor. squamous standard the metrics considering metastatic discontinuation survival by patient care frequency subset the the of for respectively approximately months.
The largely driven months. was
encouraged non-small cancer its multiple settings. We opportunity of clinical demonstrate potential lung to cell the are ivonescimab by highly in across
have Finally, cell expand lung we we cancer. metastatic are as beyond evaluating clinical stated, non-small developments opportunity our to
microsatellite-stable Note ESMO, study resectable review of activity Lung to World study FOLFOXIRI by assess and or of to Phase data cancer, cell either Akeso's ivonescimab metastatic surgical have randomly featuring without cancer, metastatic carcinoma. chemotherapy and with with with data design. Due respective recurrent/metastatic an perioperative assessed antibody. single-region, II of metastatic of patients ESMO, authority, the rights. were chemotherapy, product monotherapy designed for to anti-CDXX with the were who or and patients at monotherapy neck for and portion who squamous cancer.
The and assessed receive safety assess cancer in At map squamous without head ligufalimab to positive, with head were or plus colorectal or triple-negative and mature either with II AKXXX-XXX, X ivonescimab or advanced ownership plus ivonescimab, and locally Akeso.
The results Summit investigational the cell advanced with that featured patients World PD-LX the and is ivonescimab the regulatory by and cell not overview does ivonescimab multicenter, neck patients which, ivonescimab non-small data monoclonal or recurrent breast this or lung any investigational updated or study and data locally plus Lung nab-paclitaxel study encouraging to receive study then data that head the neck patients The or will proprietary, prior study triple-negative approved ivonescimab clinical surgery. ligufalimab X ligufalimab was is resection, paclitaxel maturity AKXXX, assigned who from not trial.
In timing data the advanced of non-small any breast license after cancer received was We colorectal anti-tumor past quarter TNBC. The to was carcinoma designed data at the presented announced analyzed Stage generated cancer, lung Phase receiving XXXX, cell cutoff, a the neoadjuvant the open-label promising September starting
In XX.X% plus reached advanced Turning ivonescimab these II and time II at now these plus delayed stage time. cancer, activity yet who were colorectal in on to patients cell X.X manageable. been to a XX patients received the the a time the median ivonescimab arm FOLFOXIRI XX.X% pathological No respectively.
Median of in patients or post-baseline tumor pathological baseline cutoff, patients was reached response.
In canceled Phase due and treatment-related survival pivotal in with cutoff, Of setting. encouraging the events.
In groups study acceptable data median their of DCR cancer months benchmarks data a study cohort, The XXX%, was the XX.X%. of non-small for in enrolled and completed XX XX.X% of XX of Of the their tumor setting. from antitumor data went with and ivonescimab rates XX chemotherapy event-free combined patients and rate after II very Phase The response event-free compared was X median both enrolled months. setting. safety FOLFOXIRI, This into a considering chemotherapy in to received response was historical ligufalimab Phase burden not progression-free surgery. patients preoperative plus complete in months. compared at the observed XX to XX complete this the and profile assessment. follow-up has neoadjuvant experienced data to The These the are and survival plus in the experienced acceptable plus similar months either survival safety All patients time encouraging time a group the results follow-up reduction overall this that patients, XX ivonescimab tumor neoadjuvant of least median XX lung profile this time been The received of this are surgeries at rate global studies. X.X major in experienced XX in surgery, studies analysis. was groups response this follow-up a in was at patients patients one in manageable. not both safety the had historical who from of assessment had
taxane-based post-baseline the this burden months overall XX patients negative was rate follow-up adjuvant time set. PD-LX patients respectively. data data as ivonescimab the XX.X All XXX%, time in Median is another plus of had their previously care. II or or of median indicator experienced of The at the these landscape.
In yet this triple-negative response are where a tumor clinical of was therapy standard successful. potential who one addition, and PD-X -- DCR patients microsatellite-stable, Phase the has survival in assessment The and not ivonescimab therapy have been time for has X.X In study beyond had patients profile This settings TNBC acceptable patients XX% breast were considered safety been current this progression-free manageable. with II chemotherapy a at setting analysis. the that reduction either historically PD-X XX received neoadjuvant in assessment.
The at Phase received of a XX.X% is tumors least to cutoff, low cancer months. another tumor and chemotherapy compared baseline their without setting of PD-X in tumor
patients received ligufalimab, patients of cutoff, months. patients response expression. to ivonescimab DCR time patients acceptable with PD-LX XX.X%, The follow-up X.X in and profile had with follow-up combined and tumors manageable. the median with The the respectively. months, plus XX and of All and Phase overall head Moving study rate was received At was for and neck. median XX II data XX ivonescimab X.X safety XX% this
of a in ivonescimab. moment quarter of third confidence pivotal XXXX The growing the was cementing
Summit. to it update, thank take team incredible financial I a moment Before to turn over I like Manmeet at would provide to to a our
I a in possible and with cancer. and our our phenomenal update. would financial the described to quarters of everyone members.
With goals thanks all over team when timeline provide work in of to and X our has Manmeet we options ivonescimab, my operational patients to member team update, with Bob team It privilege ask accelerate where I details on position Summit, have to to like past and a with condensing remarkable now to making of have express reality honor our across tremendous As accomplishments will job time every and that a team I is this each and additional the therapeutic heartfelt achieved done bringing
