KPTI - Earnings call transcript Q3 2020 | Karyopharm Therapeutics Inc.

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good afternoon. My name is Kate, and I will be your conference operator today. At this time, I would like to welcome everyone to Karyopharm Therapeutics' Third Quarter 2020 Financial Results Conference Call. [Operator Instructions] Please be advised that the call is being recorded by the company's request. I would now like to turn the call over to Mr. Senior Investor Therapeutics' Public Karyopharm Karp, Vice and President, Relations. Ian

Ian Karp

financial all Kate, Dr. discuss us XXXX today update. by and I'm you Kauffman, Karp, for is Karyopharm's and Ian This thank quarter Dr. to Thank joined call you joining and business conference on third Chief Michael Sharon results today's Mr. and Financial Counsel; Chief Dr. John Demaree, Shah, Chris Mr. and Officer; Chief Jatin Chief Officer; Officer Mr. Officer; Officer. Executive Officer; Medical Scientific Shacham, President Commercial Primiano, Business Chief Mike Chief Mason, General

XXXX an the of and Michael On commercial Mason the today, and financial call on quarter an update key John progress, developments results. will corporate provide provide then Mike of will overview recent and our the overview an third

with along the third We presentation a we Karyopharm's the this afternoon, release of at site release a the that results on plan for reference Q&A karyopharm.com. This Earlier with portion issued XXXX. are call. press available detailing to our slide Web we of will quarter conclude

forward-looking may file and represent is of filings developments begin financial discussed most statements only. report section statements and our various success important commercialization the formal forward-looking which and make quarterly Any Private from our that of will relating in indicated Litigation the make those we statements projections, include product expectations and future. provisions these of our as XX-K, of may on statements in other with that and plans candidates, as expectations, SEC, a today we materially constitute our differ views and XPOVIO, about timelines, SEC the Act in future including These of the clinical Factors to recent products Harbor result remind XXXX. of the with we Risk I'll results those Reform matters prospects. forward-looking Safe remarks purposes our regulatory today various for Actual on Securities you under of the our Form the comments, the factors, potential by including Before our

may our elect the point not on we Therefore, representing if disclaim future, do even views forward-looking today. as at these some While forward-looking to statements should date any change. any views update obligation we so rely our you as statements in to to specifically subsequent these of

Officer. we In specified. make Michael otherwise to call Dr. data note, to today's trial the Executive to turn references I'll during addition, any discussion unaudited clinical please over site data, now interim refer Chief Kauffman, unless

Michael Kauffman

make pleased has and report afternoon, commercial I'm Thank operational of far numerous and believe achievement continued Karyopharm you, Ian, sustained be continued to that future so we to in growth. everyone. and well us with for pipeline what positioning good to tremendous XXXX, accomplishments, progress the

to end to XXXX, end numerous opportunities COVID-XX and closer company of of in we the beyond. for serve As hopefully preparing for we the pandemic, get and and significant closer patients XXXX we the are and our already

clinical five types, the often tumor drug is improvement. foundational core which are best cancer to combination, pillars first give taking towards into and perspective which are mechanism relevant parts suicide. cancerous broad are malignancy. to proteins. natural cancer which This therapy. four, of approach a own defense are Before proteins, innovating cell's moment There I'd we to each have briefly to anti-cancer take each all critical and cell potentially the used drug chance in is I the some of that anti-cancer these approved generation therapy like direct XX across primary slide the become of X, highlighted to cancer NF-κB, patient of prevent to drug cells, On mechanism foundational a unique to put of and commit has we the Rb, begin, activity of X any pXX, BRACA is tumor the of and inhibitor suppressor about whose activation including XPOVIO and

impact have continue can variety to demonstrate on for that other XPOVIO outcomes is to cancers. maximize to goal the of the in in the that can from combination Our impact pillars have order XPOVIO all a improving with of large drugs

Moving to goals. slide near-term focus five, I'll our and on medium-term

this in release we the Karyopharm, that and committed core its of a Phase foremost, in do this First in met everything milestone have our patients battling issued achieved just in the remain unresectable have liposarcoma. impact we results having endpoint cancer, principle and SEAL lives you we increasing announcement patients afternoon, with may X in the increase dedifferentiated guides a to another with are with positive press significant important we the we seen a and as very line from survival primary study that top progression-free is

which total next drive first, a will line over the the higher. two years, one that critical there us, including, securing of number we Additionally, help will approval for believe XPOVIO myeloma, goals to are significantly be for XPOVIO Xnd key multiple sales and U.S.

the initial for XPOVIO relapsed approval multiple or patients receiving Second, with in for myeloma. Europe refractory

based in for just first clinical portfolio, growing KPT-XXXX. launching clinical XPOVIO, the tumor our Third, solid announced, on generate and Eltanexor, data data our and supportive fourth, the U.S. indication continuing which to includes

and oncology years, earlier finally we Phase royalties study. multiple as our XPOX cancer X from in establishment we exciting bit pipeline substantial with SEAL broad I'll approved XPOVIO turn approach that across be a inhibition next This a highlight news afternoon Please now out to assets, announced is randomized ex-U.S. the slide anticipated this continued our six, next where globe, to of treatment. further multiple milestones. to regarding across therapeutic the core of anticipate Looking three sales the indications expansion to bring the chapter contributions also could and revenue in five

the Tissue an from where of common This nine ongoing XX stage of fatal first XPOVIO SEAL such upcoming XXXX the studies We lung We treatment two SEAL As as is and evaluated care in Unfortunately, the forward cancer, that announce advanced now slide there in to results patients also into X.XX, and and more in represents in for are patients of met hazard positive FDA no detailed a data and a value thrilled the progression-free disease, in quarter Annual with entry XPOVIO with a major substantial are prior top with of representing point its significant ratio survival, with single-agent to not cancer, in solid a support but tumors. landscape plan GBM, the other most study results consistent requesting standard unresectable patient reminder, Phase and for approval commercial to also a or primary efficacy is population the believe New the submit endpoint a endometrial NDA, in increase following oncology with tumor XPOVIO potential a safety development others. important solid X the dedifferentiated liposarcoma we to dedifferentiated treat We XPOVIO solid advance Meeting. for advanced patients turn Oncology SEAL Liposarcoma of CTOS, across trial. or forms p diseases melanoma, of earlier liposarcoma, look Please therapies. of that these treatment of results X.XXX. generally. these the of tumors, or the further seven. with cancer significant Society, XPOVIO presenting the we and Drug XPOVIO's to potential at believe only the represent of of multiple advance more Connective Application, study

XPOVIO strategy innovative continues clinical with Our to be purpose. a for innovating to be

path and combination that of data solid which and myeloma DLBCL, based anti-cancer tumor cancer, Specifically, has now led to melanoma, has and particularly with cancer with been to SEAL indications, treatment been and drugs. our clinical our to and our clinical where and settings. SADAL in and lines expansion of GBM, approach earlier we encouraging endometrial treat follow subsequent much we in have seen number to to studies, demonstrate SIENDO began both activity earlier our This important Phase on lines strategy then meaningful the types, approach we development earlier evident successful populations, and others in have development STORM difficult lung continue approach commercial the larger in has additional on a with and data, expand been into with and tumor in plan selected combination Similarly, other potential. patient dramatically study, in positive X the including same

Turning to recent on eight, other highlights. I'll slide focus

strongest both These quarter the third quarterly since myeloma. second diffuse multiple driven quarter new multiple we our by the for During penta-refractory XXXX the of in results with lymphoma. achieved in initial starts compared or refractory in XX% patients quarter XPOVIO July record patient launch reflect million, increase of prescriptions a myeloma large and sales XPOVIO to year. results this $XX.X B-cell relapsed net These demand strong were

one Application action Drug of XX, that pipeline our FDA myeloma you progress, prior For therapy, of XPOVIO our at assigned New after date approval and treatment for line the accepted PDUFA XXXX. a remind recently least of supplemental for I'll March the seeking

In to on decision population. a in awaiting approval the we MAA by the are EMA a the our STORM FDA, from XPOVIO decision of Europe for addition seeking

show or in also in of several the promising at XPOVIO This in other and tumors. which melanoma, for with combination advanced programs we to includes ESMO, solid study, treatment treatment addition with XPOVIO combination for results September, development solid Paclitaxel In SEAL progress Carboplatin the KEYTRUDA of important made for the in with tumors. presentations our data and of metastatic

of front, sufficient approximately financial now the performance be the million of quarter quarter. Chief with during we the I'll XXXX. fund position $XXX John additional some on XPOVIO's provide second-half that we planned strong Officer, details Demaree, our to Commercial the sales will John? cash third to on a our Finally, operations into expect ended ask

John Demaree

everyone. and you, Thank Michael, afternoon, good

in seen nine, multiple few the that As healthcare drive of of key and past and increased usage earlier, the caregivers. research virtually, to with the are result appropriate, initiatives the families, Michael Karyopharm momentum a patients, am greater now resonating myeloma outline dedicated communities diffuse forward On market over of features large the educational of commercial for results slide and XPOVIO proud the in during where person helping B-cell organization most we drive direct in of quarters. I our quarter, XPOVIO seen support our noted continues to highlight that treatment providers we've of that that lymphoma commercial

in showed with XPOVIO's high-risk populations some very treat to having rate responses as rapid response as week, positive Daratumumab which strong as refractory one objective difficult the patient our cited of being well data included that to cytogenetics. and early patients reported as response STORM data a XX% XXX% Specifically

prescription FDA-approved XPOVIO a first noted physicians oral is blocks XPOX is being and in trends prophylactic whose core the with Next, only as dose XX cells that and reversible binds recognition there's increasingly and manageable, positive XPOVIO and be can XPOX driver cancer and shows far for that and XPOVIO's quarterly selectively modifications and increasing of typically that Slide tumor experience growth, inhibitor the increasing side-effect finally, so sales and over-expression profile XXXX. to in recognized treatments.

patient both third The quarter and second XX% a in net saw to quarter. demand compared increase sales,

momentum a to to build increase this increase patient new third initial and total third the come to introduce quarter saw to the growth in we quarter for to contributions for the for bringing Importantly, XPOVIO highlights in as the XX accounts indication. to prescribing the this patients jumped new important new myloma but we account majority robust for segment continued which XXX new Slide year. new the we starts accounts myeloma the get the of multiple DLBCL prescriptions market, of patients, continue the XXX compared XPOVIO, second in quarter quarter. The from in

restrictions secured pandemic. particularly refill the to tools shows accounts for virtual education the quarter promising and COVID-XX DLBCL in web-based These remained due significantly over as eligible to for many reflect for multiple are third conducted The but compared numbers time these physicians. those results rate the refill XX related refills. New continues initial period. physician myloma and be prescription are graph quarter, for launch both for higher slide XPOVIO as ongoing on via These second treating patients first geographies our to to and stable this

XX%, of end September For patients first of the later, One were XX% XPOVIO of which the to instance, that which marked on first roughly prescription. at -- became a XPOVIO. quarter received a year of we the second available, commercially stands get further the as in XXXX refill increasing in coupled marked substantial that going feedback an increase. positive end regarding patient a average promising treatment and physicians X.X their patients, per rates with These of cycles September usage experience from of and reinforced of number

side-effect in XX%, gaining the and manage discontinuation proper profile comfort due to side-effects Importantly, of remained helping prophylactic rate is low physicians more modifications. believe a patient to more XPOVIO relatively and therapies which patients at the their testament dose we with

the we On XX, of in Compendium share which approval. at what efforts listing a completely in translated oral option, XA response our in our space of are the in have this physicians target and the These full quarter NCCN for refractory and The launch rate able DLBCL were of XPOVIO's way. to ability market single feedback well most trends we're to secure June. weeks two attracted showed preliminary third a Early following initial seen launch research, into category first retail Based to patients and their from period agent, late patients. new physicians. as have on positive as represented from physicians multiple approval treat to XX% are treating within DLBCL relapsed we've quarter metrics come XXXX been of community-based pleased two-thirds matches prescriptions strong which myloma slide

Additionally, denials And also with seen approved side-effect being twice the XPOVIO's are been on-label finally, with date. positive for reporting manageable we've to seen physicians feedback positive hearing patient dose, dose profile the no XX patients. we care milligram weekly regarding most dynamics has

key the fully these multiple access leverage approved more patients in to and indication, also on our this will generate increasing by new impacted indication educate newly in help stakeholders, continue We excitement to to diseases. myeloma DLBCL

back to to to over the I'd call and regulatory priorities. Now, clinical Michael? discuss turn development our like updates Michael

Michael Kauffman

the remaining in sNDA Europe, multiple after the to provide In for slide therapy, at STORM in the topics our decision key the study the a upcoming EMA line activities. as filing treatment Thank for continue re-monitoring a from submitted sNDA update the you, final Advisory and for this indicating September Scientific The study results for of CHMP John. positive decision year. prior of basis summarizing updated October of was the by intends On we Group served in for we've issues end the advice, Karyopharm CHMP the patients of from XXXX consult Karyopharm a from the myeloma the one to data by list outstanding expect on expected FDA but regulatory brief to with by requested XXXX, for received further additional accepted additional submitted address CHMP and to XX, XX of our I'll least July, XXXX. the March BOSTON

MAA and an expect end data upon following the CHMP BOSTON XXXX. In of study opinion, the the addition contingent we of before submit receipt from to based on

annually annually, label would based if you For XPOVIO's and in X,XXX trial the submissions expansion paradigm. DLBCL, in between of therapy optimal slide expand United in population the now XX,XXX patients U.S. of results still studied the BOSTON third of process to the point look label and over XPOVIO fourth in impact patients and the XPOVIO's the largely treated XX. generated we're Please the we the to these and the approved an population turning study evaluating on who treated and lines in approach pento-refractory regulatory later and to This update promising an the key are in the BOSTON and our second BOSTON applicable providing indication timing myeloma is current data based treatment the of of slide potential future. forward in on the with settings. States turn important highlights data potential expanded The multiple approximately represent line multiple myeloma STORM the in from future differences trials. some

study was the XPOX refractory far therapies i.e. a action the the with BOSTON also and was previously higher BOSTON in had in of the as BOSTON combination STORM seen As given and Subsequently, and the with treated substantially fewer to two far the dose the by in disease combining study with less eight a mechanisms along in was mechanistic studies Dexamethasone. patients standard was in two once-weekly to inhibitor, therapies or than compared This drugs median median of Proteasome XPOVIO low patient treatment, in study. approach in study. been the of trial rate driven additive you prior can as BOSTON different response had and Velcade, STORM the see, with STORM and PFS inhibitor synergistic

financials, per was Importantly, to why believe to months taking XX. of that, approved in mentioned we results instead the space, single which be months I'd in these mention paradigm from if Mike? the three combination, as exciting in duration studies new make studies end the for new to to and by such investigator recently study key by to trial, be over currently Mike on XX pursuing therapy. didn't some been other as first We call in and the the initiated ongoing a enrolment have in with is our dose number Selinexor the in future the which both as in as just impact quarterly the week. which be dose our Dexamethasone an XPOVIO can And earlier, the This therapy utility also solid We've confirmatory study. we're hematologic slide treatment platinum-based today. per patient DLBCL BOSTON X studies, have in encouraged seen to I With will of number for opportunities compared week we positive regimen once mean Gemcitabine, myeloma. turn some we only combination smaller with a in greatest of XXXX, two twice chemotherapy begin we updates review the Selinexor, in Phase trials for In announced myelofibrosis, studies in nicely Rituximab I'll anti-myeloma a setting and where the comparison has initiated expect year follow study, as will other expect important on we of pipeline multiple believe Velcade in treatment and finally, remiss I malignancy XPOVIO of drugs tumor the potent combination STORM to agent the of and begun of Mason the we

Mike Mason

we gross Since prescription based Michael. slide the sales today with revenue in begin were by you, XXXX I which a full and growing demand million, Thank was of for third our from on XPOVIO The highlights with Net earlier approximately was quarter product quarter XX. academic growth. of community estimated third $XX.X focus a release on press channel issued range third just results, quarter XX%. inventory actual discount in net with driven for sales the patient line physicians to will

primarily expense the trials. ongoing was compared patients launch was the million expenses to continue commercialization quarter the expect of discounts U.S. between was compared of to XXXX refractory $XX.X the quarter continued third XXXX. was compared expense XX% our third for this for of year. $XX.X quarter for support gross expenses expenses to activity to other We net fall of XX% to in to the $XX increase million development with due Research to the as or mainly prior-year for quarter to and for the R&D third clinical SG&A third and third XXXX. million, treatment the remainder the the XXXX attributable SG&A of million trial relapsed in quarter in $XX.X related XPOVIO increase activity compared for of The XPOVIO COVID-XX DLBCL. of to and to activity The XXXX including of

operating XX, the from range on expanded the the catalysts, as As equivalents, modestly September the $XXX as non-GAAP expect XXXX on XXXX, the to current totaled expected million, the growth our December XPOVIO on study. XPOVIO million full-year currently compared slide for million. of for $XXX.X $XXX.X R&D more expenses we following based of plans, XX, to sales potential significant in of our remainder approval based projected restricted million SG&A BOSTON and Based XXXX We results project expected previously XX, $XXX and investments, of to noted on with cash grow of to cash, XXXX. cash

and XXXX. our call currently some sufficient will and the I'll we expect investments, expect product our we in addition, to revenue fund for planned In the from Michael XPOVIO existing Michael? remarks. operations generate now to cash cash, back be that to concluding turn of second-half equivalents, over sales

Michael Kauffman

Thank you, Mike.

clinical Before moving milestones highlight the XX. we regulatory expect shown some that the of slide of to let the remainder as key Q&A, XXXX, on and me for

important this you As throughout we milestones see, can end accomplish key many the of to by goals achieved but have year, the year. have still

decision MAA. expect EMA STORM we First, a the from on

decision to we X the of continuing of where review Next, the and through I'll in the plan to decision questions. call keeping of your EMA over before the look from course, XXXX. the upon our turn our date XPOVIO on on forward CHMP's to support, support we'll XX, anticipate on the the you support year the the appreciate continue PDUFA to or submit STORM studio future DLBCL receipt operator approval, FDA following based and expect study, recent end the March confirmatory on the progress. MAA. initiating our before for in We of now sNDA ongoing FDA data we BOSTON finally, the And of BOSTON Phase we full accelerated a our of Operator? and of updated

Operator

is session. will question begin ahead. the Jonathan SVB Our first now [Operator from Go Leerink. We from Chang Instructions] question-and-answer

Jonathan Chang

readout. questions, congrats positive on much Hi, for and SEAL very taking the guys. Thanks my

has your landscape, can what, liposarcoma thinking broader treatment tumor First dedifferentiated you if regarding talk any, read-through question, for opportunity? about And the XPOVIO? this how opportunity this the you solid commercial see on

Michael Kauffman

Sure.

during Unfortunately, some with patient treatment Let is give the get anthracycline, their this. Adriamycin liposarcoma by Pretty Gemcitabine dedifferentiated in, will cytotoxic because can't parenteral will lecture agents. in dive receive or combination me other and and/or Eribulin a I'll on populated be course. chemotherapy most every brief cytotoxic, patients Trabectedin only we like landscape much

I are furthermore, study this largest be oral the clear XPOVIO study no largest therapy the and believe that liposarcoma performed, ever and indication, there liposarcoma used. routinely it's treatments documented could dedicated is that have are of in performed. approved activity first and other this really ever the Beyond potentially

drugs used, really can of think option provide we chemotherapy better believe, real, pretreated. patients is oral for we could become a one and important are we tolerated, these who after heavily the So

Jonathan Chang

it. Got

on one can questions on topic, the Just you I October, question a that outstanding additional different follow-up the said. color think from received CHMP in then you you provide

Michael Kauffman

Shacham Yes, Dr. I'll comment. that to turn over to

Sharon Shacham

can follow-up? Michael, sorry, start, and you I'm will I

Michael Kauffman

EMA some believe the that the I the think continue the was and provide information has from some the patients Sure. questions analyses we who of EMA additional of ask they on as patients, on laboratory provided question previously, the in the color requested particular, responding of and regarding we've to can described in some EMA. additional study, us, were those to I the we've

addition, us as continue of the the In the we've justify application. EMA in STORM to as we support provided, asked MAA to benefit-risk, data the BOSTON provided

Jonathan Chang

Got much. it, thank you very

Michael Kauffman

question? Next

Operator

from is question from ahead. next Lawson Barclays. Go The Peter

Unidentified Analyst

there. This thanks on Congratulations [ph] question. Peter. is data, our for positive the taking Hi for and [Mitchell] on

much by? the first you'd X.X, have those and SEAL, FDA would as beat how in say qualify hazard meaningful the expectations the So question wondering, what ratio for did I at came or just the

Michael Kauffman

and considering believe The advice, of has FDA EMA consistent, trial the potentially it well-conducted also FDA, we and that. to both the to and hit trial advice the which What provided EMA, post-meeting have internally X.XX, as say in means statistical doesn't basis could from for FDA that serve have you from that that this and has did, been. an we which that approval, generally the boundary be they and the do, the advice scientific particular

hazard the this for. X.X, FDA study Phase X, was X expecting the should that that so what was this as the was Phase aware hazard went into goalpost. in I ratio it in portion they designed believe which that, is also we the X was of essentially EMA. a about hit of And mention ratio of Phase we So identical appropriate the to

Unidentified Analyst

Great, for thank real myeloma, you. discontinuation XX% what world for beyond And the expect comment you'd PFS? could study, the just additional Thank CTOS with should then data rate consistent the we seen and at on is in you. if then you SEAL the that

Michael Kauffman

it can one was systemic can't lower, have. patients as patients these rate, the say would I would dose not the that but -- end-stage myeloma. the I comorbidities much therefore have as pretreated discontinuation lower. They addition rate less are Yes, here be And expect myeloma was last-line that patients dropout exact to with in and heavily also speak

the at So DLBCL used the dose the was similar you might SEAL SADAL study. in being to study look more

be it You'll see time presentation and a the by should at our will And permits, full far given as be a investigator, complete this lead CTOS. dataset. that, as

Unidentified Analyst

Thanks, and congrats.

Michael Kauffman

welcome. You're

Operator

question Our Maury Jefferies. is from from next ahead. Raycroft Go

Maury Raycroft

everyone. questions, my Hi, Thanks the on and as for about question my data congrats offer liposarcoma myeloma. I'll a taking ask well. I'll

patient in as So patients new you impact? COVID patients, seeing can you DLBCL the with break preferences talk XPOVIO at per you too, about XQ, line of and the out for for also if combo myeloma And cycles new well, treatment X.X. the what and some of can are you then, and mentioned average treatment

increase in earlier then or the a expansion that the up? in if you continue the the leveling around off last opportunity line line that into that you Just setting go with current potentially when to market get do to expect you and see could patients number wondering X.X,

Michael Kauffman

that encyclopedia. Maury, quite an Wow, was

Commercial Chief but being to that. short, bit John address Officer, we'll So keep it And ahead, our I'll little a John. Demaree, to ask go

John Demaree

those, any keep me on If of it. I missed

Michael Kauffman

Yes.

John Demaree

BOSTON let expect Velcade and that Xth BOSTON with But in Currently, the we first, majority line+, of approved. with do obviously to of earlier me answer is earlier is XPOVIO therapy. combination one the about Velcade once XPOVIO in in indicated. as for use indication are move seeing We the lines use

Dexamethasone, of that research significant using our XPOVIO in expect it's XPOVIO and prior from physicians Again, of new do we line the that Xth usage for we just community-based of indicating. on get with lines not they're it that market therapy. the prescribing combination currently line+ primarily other setting approval with now patients know where in acceleration earlier are indication You in academic it's many plus drugs, so once

be the research and do terms be actually question nurse Our to goal impacted? prescribing of compared impact you do affects, in-person suggests have more it's force, HCPs behavior XX% our to appropriately to habits, the payer liaisons stakeholders pandemic, visits. teams continue virtual to In pandemic of in sales maintaining by the to in-person XX% about We second the like around continue to and visits harder via think to educate still multiple believe data environment continue as change does can brands. of seen of a established

including done large number in teams have to doing targeting We and in to effective are being education, increasing networks systems the patients offset impact better non-personal setting. virtual and identify to other our physician their content, some digital and the virtual, of finally, EMR be training peer-to-peer penta-refractory how initiatives promotion and field more on increasing of environment, a the

of the questions. the were So, two other What questions? it's

Michael Kauffman

I think of be of is of we're to treatment say a which about launch. close at number we're level year -- -- over at X.X yes, the into September would end just the maybe there the mean average through what -- one was or we're that little a bit and the I duration I cycles, excited

go months I of in months on the BOSTON because that think as then within hopefully number duration -- the Michael closer was the as in of duration higher earlier, population, the treatment on launch mean into average will versus get significantly X to XX some extent, STORM. and BOSTON BOSTON mentioned treatment we

with reality soon at it getting little think for is treated who the bit XPOVIO patients BOSTON be hopefully can think and on much and but -- then I longer. I be go will going to pretty up earlier approval, hopefully stay treatment potentially, So, will higher, we're drug a come to

Maury Raycroft

guys. you, thank Great,

John Demaree

you. Thank

Michael Kauffman

Next?

Operator

Go ahead. Brian is Abrahams next RBC Our from question Capital from Markets.

Brian Abrahams

use access, physicians for Hey the and data. the in myeloma maybe guys, expansion. my and label are line to guidelines XPOVIO thanks taking can't on publication? but timing or congrats even BOSTON inclusion the access prior the SEAL how earlier earlier post presentation, Any I'm degree NCCN on do might frequently curious questions, for line which open the to up update there timing in to looking BOSTON

Michael Kauffman

that of guideline know come Again, journal, the BOSTON peer-reviewed it but soon, before that the do be Yes. expect published maybe out Well, exactly, edition. but year, edition, hopefully know. sooner. the will don't in we of we don't end hopefully and good facilitate an a speed publication will the to NCCN We

week NCCN where one Selinexor that of impediment expectation not this Our for folks. all We the a right insignificant a actually therefore earlier which the is or a myeloma believe simplest plus to insurance that XPOVIO of for line number basis dex is the refractory can once Velcade now patients coverage and with you the regimens really combination to as beneficial be places of or relapse could major of there -- therapy, guidelines adoption. is use are prior

will So, that we're out be once facilitate access FDA-approved. course then NCCN and of guidelines can the ultimately hopeful we come

Brian Abrahams

COVID of the then, some curious how and the the a of of fewer take wave medium use to engagement, Thanks. and if just wondering available I if may term, in second CAR-T able administration forward it, conversely, third DLBCL. multiple expect of to even of for I'm patient I'm the and near-term of perhaps the pandemic uptake. effects near your benefits in continued as mentioned that oral follow-up, facilities I expectations advantage of physician administration is may seeing challenges guess you or you'd and that some Got or we're continued to looking having, you be guess the impact

Michael Kauffman

So, Obviously, your opportunities, current peak there during many therapy the visits is less of yes, the time think question for patients, pandemic preferred, and situation. an are are is in answer impact. particularly COVID I challenges the oral there to

is I as mentioned, more also, think physicians difficult to engage it you in-person.

some promotion digital are earlier. have We just of offset of initiatives to more I do the to tried mentioned non-personal and and continuing offset more terms to in that that

Operator

Joseph Our Go next question is Morgan. J.P. ahead. from from Eric

Eric Joseph

good Hi, question. thanks for taking and the afternoon,

the to as get advance interest, up treatment liposarcoma a in relation whether paradigm Selinexor in of in as earlier the liposarcoma I XPOVIO? to whether the see for you opportunity then First, maintenance, to curious an have of strategically either follow-up and on an I'm and chemo a opportunity, that's to sense SEAL alternative or

Michael Kauffman

about, SEAL and Well, needs [type some earlier population they've focus activity. internal There's of therapy. showing groups from to to year, in of the it's been [ph] data and although because given is that interest per addressable groups of a continue groups course small probably liposarcoma lines larger you resources a obviously bit important disease our were Part relatively studies X,XXX of that differentiated, patients we with will. heard if is you want good in] that expect just an various the which additional outside tumor we in around

ongoing. is study SIENDO Our

For for a blinded those Selinexor then, and placebo patients, all least versus which weekly matching that couplet, and who randomized no in three receive of response have phase is of now, recall, who once don't essentially then, cancer them right platinum-taxel a this is of relapse. folks study a with endothelial patients maintenance partial these unfortunately, chemotherapy, frontline therapy we and there's typically XX% those at know will approximately

maintenance chemotherapy conducting SIENDO big focus. study in first we're and the study a That in is that's So, after setting that group, ongoing. line

within of fairly a year, data before and a next medical expect that's end bigger substantial need. the population size with We --

be we the and the So, mentioned our earlier some you at agent in that then about other next GBM some places that heard in to will data clear show big which activity ESMO intend of of we solid of course tumors, focus pursue. where single and

So, we're will the NCI move move of to other to that CRADA interest advantage our take in the in external with all shown have going area. sarcoma to try fronts, and groups

Eric Joseph

demand -- could, just like agents DLBCL just in community DLBCL? actually other from of of it do kind maybe line and I'm growth demand third sort growth commercial, line between could conservative if opportunity term? a I much coming was expectation and in skip visibility third trying the of does sounds good terms DLBCL. see unpack XPOVIO had how square you of a of Are wondering balance myeloma much also near some helpful, the in represent the how I'm the DLBCL, is question much That's pretty How of of to growth on just setting? competition you in you opportunity year, where seeing you just much from guess how coming and on from demand you if the of

Michael Kauffman

in reasons, an the were to for the that continue important DLBCL. The third grow sales time. prescriptions is don't came out believe patients What from first question, we majority over So, we contributor competitive break address can to of separately quarter and multiple that tell between the will DLBCL you myeloma. we myeloma multiple

John Demaree

data certainly we're a from we're and quite pleased we forward, that obviously balanced just moving good, be, this still we as transparent in get we've to look that myeloma starting in and Yes, we a the challenges, think the -- continue midst pandemic are DLBCL some but some NCCN in that of talked expecting, when we mentioned, obviously as particularly talked and BOSTON number COVID can quarter-over-quarter, of to DLBCL, and grew as metrics possibly landscape about, new see we getting publication DLBCL quarter, terms entrants XX% the with we're few actual which of and -- about, catalysts you which and the contributions including competitive we growth create space, come mentioned does also those been have we'll we've is of I the competitive think and momentum. guidelines there I launch in we're

all create pushes pulls. and of sort those So,

upon near-term our that clearly Europe myeloma. the BOSTON working biggest in of sell piece line second the we because and as with approval in into ability I the as ultimately FDI the going continue driver to know submission multiple think to that to and our eye is well be BOSTON in on we growth keep

forward all So, you drive abreast the those to next growth six those think things -- we nine and over keeping things. to are three months, really the of to that we look

Eric Joseph

question, the John. taking for Thanks

Operator

from Go question Morgan next Our from is ahead. Stanley. David Lebowitz

David Lebowitz

for my very much you question. Thank taking

quarter the XX% to that second are similar sales quarters, stayed the convergence? quarter, of causing what over to I third between the dynamics two prescriptions from those quarter, Given the and increased growth prescription how cadence XX% ultimately play sales from pretty relative at was to guess demand

Michael Kauffman

Yes.

on is a well. little coming I we we basis, different than -- community are scripts monthly largely I as that's in from as the think from the I monthly that coming early saw terms community think well if the not typically which on of disclose as yes, they're cadence bit myeloma, where academic coming base of in some some I basis, sites, a large physicians, is based a multiple uptake both sites which was think from. Certainly the something in mean on DLBCL a

I to add think was If John, I anything? your missed that don't question. I if you it, want know

David Lebowitz

tumors? And type, going data, respect guess with given other respect does give I forward specifics the regarding you to I to how solid that that liposarcoma with tumor confidence guess,

Michael Kauffman

for hopefully very and tumor anthracyclines -- regular approved there type but in Well, drugs generally liposarcoma, benefit I've think large said The before, the very effective the we every differences and all drugs and that essentially therapies, is show fact these have a cytotoxic are to was different. there's and I similarities no are approved are These difficult we real difficult fact could They're access, chemotherapies and really line thankfully agents. think in virtually large it quite least two are more Trabectedin, it be following can that are this third we at in see to that a a connective population chemo tumors. that those is and option, this can especially These the very growth, penetrate patients fact non-cytotoxic tumors. speak perhaps XPOVIO drug difficult. which clearly slow data tumors, line important for tumor for an reading setting, can this does penetrates second masses, but and and solid which particularly agent, third tend responses, tumor, go unusual tissue, about are in we'll show gives to some other the solid to that particularly into

positive the the in combination been place and studies. different its seen results represents before. great type, ESMO are quite data other helps of our This cancer. early from that the think So that's always third disease this in we've We about beneficial and reported foundation. we've disorders provides talked It also hematologic some a solidify from

David Lebowitz

question. my answering for Thanks

Operator

from Baird. Our next from ahead. Ulz question Go is Mike

Michael Ulz

guys, field related data. the Hi, all and an as progress on earlier question a question congrats for to well. the just thanks I taking the follow-up on had

the further Just beyond on you're how to compares seeing wondering safety little comment if profile, that you and maybe there bit maybe label. a the rate, discontinuation

a looking Just sense I anything that we and different for, should be notably follow-up? get trying if to have there a quick there's

Michael Kauffman

two tends it that quantitatively, particularly Sure, profile Remember, be what you've what can said with we to coming prior substantially we of with say on safety we the qualitatively, seen before, therapy. a that's in patients what press cytotoxic cytopenias. kind in consistent see is our these less are only is

a suppression. kinds BOSTON lot in that as marrow even Bottom much marrow. healthier not have even line treated the BOSTON. compared patients marrow their on they of a don't They than is of bone to So, have disease we've myeloma

saw, and a the and expect may is come XPOVIO. baseline in the are worse you and not we So nausea, these get or because the like abdominal fullness GI less structures, patients and better can abdomen, which on what in compress may tumors and which cytopenias, lot with or frankly, often unfortunately pain, often

like levels in baseline this basically, without looks still but cytopenias. higher expect of nausea, extra So

Michael Ulz

follow-up, can liposarcoma That's of in you. just about solid quick a other couple of little mentioned tumor other confidence timeline types then helpful, Thanks. a in these some kind these or talk for tumor just opportunities Maybe Got there. of you some a you tumors you gives and in your bit types? this more strategy

Michael Kauffman

recapitulate is patient non-small to treated that cell hands. an mutant study the yet ongoing, not Selinexor cell This have type investigator company's going be cancer Phase lung combination some and We I where was elaborating some were previously by to Group. Seli KRAS additional we're plus I things and KRAS Atomic we Docetaxel lung data non-small public think X both say on Docetaxel XXXX, already some based in want trial plus in seeing studies. wild should of in Phase sponsored ½, from we the interesting

a we We approximately have ongoing update where that and or GBM agent prognosis. refractory Temozolomide relapsed have to dire single rate patients or studies response announced in GBM a XX% have continue we'll bonafide radiation on in

and on internally seen in and bunch and in be of those. with have tumors going different some including through patients our of forward on a combination We collaboration moving Taxel Platinum in both these more data NCI we'll solid or who've again XXXX with already platinum-taxel, of

in excited saw nine there our data distinct major which that effects are and were combination with able importantly, to in we're potential combinations, other of autoinflammatory and response up the if melanoma Opdivo KEYTRUDA. some plus open importantly, no combine about with exciting sort from can without quite and the and in untreated Yervoy recorded, modifier similar deliver. possibilities we combinations autoinflammatory tumors but up study, tumors, it is the types CRs investigators may major KEYTRUDA that quite multi-immune we of those thought including Lastly, melanoma, effects very X side initial XX% melanoma of patients with possibilities side other Amongst that rate opens

Michael Ulz

Okay, great, you. thank

Operator

from H.C. question Ed Wainwright. Go ahead. Our White from next is

Edward White

Congratulations questions on field a data just and the couple of tumors. solid on

Thanks. first pandemic, that the So just the we How enrollment hiring had solid how been when you wondering trial, is I'm trial. how and the by has and mentioned up launch could was patient solid the GBM a for patient see strategy study, what Phase on think this I you the what many impacted just enrolled is your strategy tumors? going sales is large data June and in X/X the your people then in in So question small, build with do are XXX it that, thoughts in force? tumors? liposarcoma

Michael Kauffman

Sure, first study. going question to Dr. so on to the ask about I'm the GBM approval take Sharon? Shacham the

Sharon Shacham

study, three relapsed patients patients with well moving arms enrollment refractory in any forward. design, CORONA a and decide for plus the from studies impact this see including another and newly arms, with to all study engage arms three on we don't three is has two GBM and and the diagnosed enrollment at study The are in disease, then that arm looking with going

Michael Kauffman

Excellence. Maybe patients standpoint, with XX Centers certainly, the call vast so or the that of down that do or are then about reps total, of the side those from combination, U.S. of liposarcoma of the whether I will fairly Lion's a just space, here or majority seeing Excellence for probably a liaisons, a certainly them sales point patients but of treated XX so solid in treated all U.S. and there's within U.S., quickly sarcomas across at think on of or we in that's with Centers could you straightforward something That's the probably as the certainly folks, are are be medical to science of can share narrow commercial things, the handful tumor

the cancer these be study much Endometrial As sites. knock number seeing to out you at study, obviously that solid should to tumor vastly That's ENDO patients that's on are of indication, positive? wood, a get significant larger, start study, a

So be make we commercialize But a have to commercial at looks that in think decision, would that to we'd look certainly, Endometrial to what issue a terrific, take have a how and like model would about cancer.

question? Next

Operator

from Go And ahead. Lawson have Barclays. follow-up a we Peter from

Peter Lawson

a Sarcoma to just you data as the the think need using able congrats that can on taking data different will my would submit EU, we trial initially treat you for thanks that, and how you with that and to Hey, about questions, should a be patient but label?

Michael Kauffman

receive Advice from did their Scientific trial Group. Scientific this advice Well, expert EU the from positive

and we -- patients been received it It two it's do the systemic approval would be So start EU, it have prior discussed them. believe the for could with on-label indication with therapies. with was them dedifferentiated liposarcoma in was there approved that

Peter Lawson

be solid patients, Sarcoma data And what okay, after about, tumor? endometrial, should or number the what thinking then is of patients we because there's next the room a on for that next XXXX and think what is we'd the about

Michael Kauffman

say including tumors, during the with tongue especially of out and well both year. combinations, in terms the with data, Phase huge other other hard a In a next company of hard, with that say size, but next the next end in it's that year data lot these There'll to within of and trials, are one, by I in solid is yes, can and conduct cheek, updates as of it's our little potentially myelofibrosis yes, as a be X randomized areas. be should the year, hematologic

Peter Lawson

you, the or treatment and do of just on myeloma multiple DLBCL, you myeloma DLBCL? multiple duration of then sense Got get a in

Michael Kauffman

at mean we're average -- on I three patient. per our about specialty it's about I months pharmacy Well, mean, across network,

at started, it's a you'll climbing. yet, is longer, or months, for right so three DLBCL have get months, out don't patients and now not patients two those some that XX but response again three and the have months, one been you'll patients Now are just XX, about average after and

a little on and probably it for bit the it'll indication, drug higher second BOSTON can We we when much Someone asked because can third the if how it go but those stay time. much go longer periods think obviously patients in higher, go? get substantially higher, and of an probably line, once earlier question,

Peter Lawson

that you changes, thanks, when and around guideline question do just happens? Great, just final think

Michael Kauffman

their myeloma, mean out is to publication before out, you for will I publication recommendations. have year, coming it the the assume there add will a that in the a end when peer of be be to and submitted the and you to believe NCCN works publication the regimen procedurally have with be and journal the that when they timing way reviewed will Committee determine will they a of we if

Peter Lawson

Could XXXX? that of that more do or be than think kind year-end you

Michael Kauffman

Eventually, timing publication. publication the the could and timing it NCCN depends really the be, it Committee. It on the depends of on

in publication adjudication. potentially those of NCCN course will BOSTON to publication, Kyprolis, we this all but submitting Pomalyst, Daratumumab, with In the the particularly addition study dependent results, be single-arm of other and and could upon is follow,

Peter Lawson

Great.

Okay, much. Thanks. thank you so

Michael Kauffman

you, your you look thank us Well, again we everybody. Appreciate near-future. the following and to talking forward in with to

Operator

The for you conference Thank has now today's presentation. concluded. attending

disconnect. now may You

Ian Karp	VP, Investor and Public Relations
Michael Kauffman	CEO
Sharon Shacham	President and Chief Scientific Officer
Mike Mason	CFO
John Demaree	Chief Commercial Officer
Christopher Primiano	Chief Business Officer and General Counsel
Jatin Shah	Chief Medical Officer
Jonathan Chang	SVB Leerink
Maury Raycroft	Jefferies
Brian Abrahams	RBC Capital Markets
Eric Joseph	J.P. Morgan
David Lebowitz	Morgan Stanley
Michael Ulz	Robert W. Baird
Edward White	H.C. Wainwright
Peter Lawson	Barclays Capital

Karyopharm Therapeutics (KPTI) 2 Nov 202020 Q3 Earnings call transcript