IMGN - Earnings call transcript Q3 2019

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

Operator

Good morning, and welcome to ImmunoGen’s Third Quarter 2019 Financial and Operating Results Conference Call. Today's conference is being recorded. At this time, I would like to turn the call over to Courtney O'Konek, Senior Director of Corporate Communications and Investor Relations. Please go ahead.

Courtney O'Konek

Good morning and thank you for joining today's call. a progress that financial and issued of a results. we recent our third today, press includes release summary Earlier quarter XXXX be at immunogen.com. This this & a and section found can Media website press Investors under our recording of the release call of

our today Vice Berkenblit, join President Dave Affairs Quality; Medical the of and call President Foster, CEO; Wingrove, Q&A. and Accounting for also Mark Regulatory us are On Officer. Officer, our our Theresa Enyedy, and Anna Chief Senior will Chief our and

we today's third During milestones. recent quarter financial will call, review progress, results upcoming our and highlight

During included use such actual statements. discussion, our in investment uncertainties statements from results the of and an risks and SEC filings. the our we will Descriptions associated materially are may ImmunoGen differ with forward-looking in

that, call Mark. will over with I the to turn And

Mark Enyedy

Thanks, and Courtney. joining you us today. for Good everyone, thank morning,

late restructuring line the third business on positioned set start next priorities we reduced we our announced the mirvetuximab year-end, study early significantly quarter, for Phase Following expenses. shareholders. advanced we’ve value our in execute portfolio to stage during by to moved the the these objectives, build and our the operating forward for we June, X and with In

September. and of XXXX of receptor met data platinum-resistant continue and by to cancer exploratory to momentum anticipate to of compare our high we and patient the express study, X agent year. patients, analysis design end results allow coming with MIRASOL whose enrolling with proceed from year. MIRASOL review mirvetuximab call chemotherapy new tumors confidence look the single who mirvetuximab to important FORWARD valuable will These Phase a We to the benefit We milestones folate we the pursue provided head-to-head the first full patients alpha. FDA ovarian us on as with in for which and at we levels this a exit deliver in of insight mirvetuximab, in most ESMO number Beginning presented into I with

cohorts with standard we both triplet In parallel, and September. with that will compare the from data mirvetuximab cohort continue favorably safely triplets. Xb for dose These carboplatin II other ESMO with data full initial Phase encouraging combined be at dosing can in presented Avastin encouraging anti-tumor our combination advance demonstrate those that of to to FORWARD of responses

September. our also second cohort mirvetuximab Avastin regardless patients completed cancer in ovarian in in enrollment with plus We of platinum recurrent status

the during and We will the data from from data report longer initial triplet term doublet XXXX.

in our continued to ADC, Moving to which anti-CDXXX portfolio, Jazz. with IMGNXXX, we ALL with make our are and stage our now we've progress earlier under developing AML, collaboration BPDCN

patients enrollment the enrolling Phase expansion Over relapsed quarter, opened expansion cohort as in BPDCN, now study in patients the of with we've last continued IMGNXXX an relapsed X and AML and ALL. monotherapy with

studies IMGNXXX, therapy. well a and combination have initiated cohort in induction venetoclax monotherapy AML frontline with minimal azacitidine and as who disease also following relapsed/refractory unfit residual We patients, as patients

in be data preclinical AML Lastly, A that month, trials presentation presentations next we data clinical are oral in made posters. and including presentation will at updated and XXX of to pleased four share an two progress combination monotherapy of ASH BPDCN, poster

assets the ADC. we additional in XXX, two addition our with continued that In demonstrate innovation momentum to advanced positive

alpha expect half preclinical mid-XXXX. in enter anti-folate the be MacroGenics, first First, in And receptor the is XXXX. in generation collaboration ADC of our with IND to next IMGNXXX IMGCXXX planned we to filed for second, development

coming important with progress and sound months. in number overall, a the quarter milestones this So portfolio the of

are our the to financials, Turning this issued release the covered press now in morning. details

So just a few summary results.

second XXXX. lower from in of year business expenses expenses million all non-cash the restructuring by end of of $XX This research During to expenses FORWARD commercial of trial quarter the period, million in the X activity resulting driven external XXXX, lower from quarter to with the the primarily in third-party costs of royalty period. revenues. activity clinical decrease clinical during which I we trial and the at support the $XX.X Phase Operating and greater the prior was $XX compared in of R&D manufacturing driven in million million year personnel mirvetuximab $XX.X in nearly the quarter, generated approximately third were lower current costs period validation by in prior due came revenue, the comprised same

and in In to the million charge restructuring $XXX addition, expenses retention the approximately primarily million to compared of related we third due primarily to the G&A $X and expenses in sheet. from recent costs resulting resulting had XXXX, balance quarter million in million incurred higher from the office we $X.X a facility-related restructuring. allocation the on quarter cash with laboratory of space ended for excess We $X.X

restructuring, of our benefit the full today. With financial updating are we a following quarter our guidance

million, reflecting collaboration recognition Jazz of our For revenues the revenue million deferred $XX the we between full related year, of $XX to expect discontinuation IMGNXXX. and under be to

We also $XXX to $XXX between at million expenses between to expect be be and our $XXX million and $XXX operating cash year-end and our million million.

the With in over with to that, our review more progress detail to mirvetuximab I'll call Anna. turn

Anna Berkenblit

Thanks Mark.

and review provide details for I'll briefly trial. data First, to decision informing move I some FORWARD FORWARD MIRASOL the our then the with additional

did independent achieve survival, in X.XX of mirvetuximab subgroup the alpha endpoint are we the for PFS for primary we blinded, by observe hazard FORWARD efficacy folate I endpoint that signals not ratio did high its primary of consistent with pre-specified review. disappointed receptor a progression-free While

confirmed response of of X.XX. received at in compared patients a rate with chemotherapy chemotherapy longer who analysis mirvetuximab primary hazard ratio Similarly, for higher also Overall was than mirvetuximab time survival with was the XX%. the overall at for XX% the at

these, consistency efficacy FRα reinforce cannot statistical significance the claim population. data the the data the nominal for of pre-specified anyone and high the we in the While of values strength of P

these of with have mirvetuximab. outcome that data, to the previously we understand assessment factors top-line better achieve observed from conducted the efficacy steps analyses insights next these with important we the a FORWARD setting. While inform to did gained not this contributed comprehensive in may I, outcomes in To and our encouraging, mirvetuximab results had the

of a Briefly, that FORWARD tumor simplified than FRα a expression into with FRα patients learned for the inadvertently we intended. to introduced lower method expression samples assess I levels population scoring of use of

endpoints samples expression those since X from I rescored our we the methods have call of levels and FRα with upon We the which using patient trials for high X FORWARD used PSX+. in And Phase with rescoring, patients our much high activity experience, the correlating we FRα with observed patients. treatment efficacy more the outcomes intended strongest expression for in-line efficacy FRα all with previous effect in for improved and mirvetuximab

results with with associated longer PFS median a with survival compared mirvetuximab ratio chemotherapy, the from To of analyses X.X X.X exploratory was of versus progression-free summarize and the X.XXX. hazard months, a months

overall look chemotherapy, of on XX.X investigator assessment. XX%, in-line with a of the XX% we versus in in which response independent subset trends FRα-high overall versus continue rate survival namely defined more hazard at X.XXX. we by months, mirvetuximab associated survival higher approximately saw Similarly, for blinded, with is median with X overall chemotherapy. X% These mirvetuximab, XX.X also patients ratio when longer review was a mirvetuximab PSX+ was compared with ORR with namely Investigator higher Phase assessed months what with based received in who

select patient results trial for FRα-high demonstrate mirvetuximab the how of our in The exploratory population. cancer informs we in patients. this will for ultimately MIRASOL using endpoints exploratory summary, monotherapy efficacy ovarian patients is effect our strongest defined these PSX+ And the trial. analyses the treatment in So new future analyses FRα-high design of all called PSX+ scoring

regimens. or mirvetuximab ovarian investigator’s PSX of agent which to X trial in pegylated to high be of criteria doxorubicin Phase using MIRASOL weekly or three method, of is platinum-resistant choice topotecan. Eligibility levels a with single FRα-high one-to-one randomized patients mirvetuximab will with cancer up with either been chemotherapy, patients who treated soravtansine paclitaxel, have the scoring XXX include liposomal receive prior

by primary key of endpoint design assessment. progression-free The of they rate, patient in response XXXX. is and this the The by of reviewed MIRASOL reported anticipate recently year survival We the include of FDA top-line the overall with a endpoints first expected half overall end and our study patient outcomes. with enrolling the survival, first readout secondary investigator

the our briefly regimens review in trial. I'll II now progress FORWARD combination with

initial ESMO. cohort, combination who earlier Avastin expression to mirvetuximab As the triplet received have lines two the confirmed in XX%. a up patients medium evaluating with of and rate with level, in therapy, encouraging FRα rate response or In prior data triplet complete XX at patients mentioned, with from response disease of the presented was with line high for carboplatin overall we platinum-sensitive recurrent XX%

populations for only outcomes triplets. These those confirmed line, of prior carboplatin XX% response bevacizumab are complete to and response the overall one patients efficacy a In similar rate subset the in reported patient XX relative was rate of XX%. with with encouraging based other the

events were on side were new as expected adverse agent. no identified each Additionally, signals safety profiles based the of and effect

year, in updated next cohorts, And to triplet ahead data additional bevacizumab combinations initiated. well the setting will mirvetuximab platinum-agnostic we as present combination mid-XXXX. as FORWARD from initial the Looking II data will in be the platinum plus platinum-sensitive

strategy Turning we believe that disease. doublet moving are with positioned to well platinum-sensitive our and forward, our combination in data we triplet

in as mirvetuximab disease. evolve potentially frontline to a and generating new platinum-sensitive in then settles maintenance additional interested landscape paradigm, the recurrent and incorporating as in data in for plus carboplatin PARP doublet continues platinum-sensitive We treatment settings are into setting, the bevacizumab

and disease well will We be additional will are therefore that platinum-based longer platinum-sensitive need with tolerated. believe the combinations patients living

that, With call for we questions. open will the

Operator

first [Operator Peaker from Instructions]. Cowen. And Boris comes of question our

open. now is line Your

Boris Peaker

you there Just timeline maybe if a pivotal that? to were want specific sense combo the And a of, into do a or development? start to what's plan on studies potential maybe making, the so, you combo get novel just to is combination behind advance comments a plan

Anna Berkenblit

Thanks, Boris.

for data carbo, and well generated carboplatin bevacizumab. we've the mirvetuximab triplet mirve So plus as encouraging as

for combination the are of to the plan getting yet. combinations have that we MIRASOL But as not So year. planned Right And next our the we primary now running. And us working up our move next is quite details these moving we important on on important study platinum-sensitive into start focus a up are view of two quite space. as platinum-sensitive into step. space we an entire the finalization and

Boris Peaker

the And X question prior non-PARP? what use PARP relative pretreated of being seeing do I, were your curious to your How with the fraction -- had PARP Phase PARPs PARPs study? And on how I to do or in in the subgroup you see FORWARD kind just patients another pretreated maybe new of did subgroup drug? FORWARD

Anna Berkenblit

Remember, in being PARPs XX% a patients platinum-sensitive FORWARD we the in had were about PARP. I when as the and setting studied of FORWARD in maintenance treatment enrolled setting. So approved prior I were

disease. setting patients a higher MIRASOL about in patients expect PARPs of about at had patients have did that prior said, prior look PARPs. platinum-sensitive benefited had PARPs. patients mutations maintenance who because had over FORWARD have percentage as chemotherapy, in So in being not That when XX% PARPs, subset and prior patients and XX% I mirvetuximab BRCA of We incorporation of we prior did the of they do the of who from will the

PARPs we regardless So has not. nice believe activity of or mirvetuximab very prior

Operator

Thank you.

John Canaccord. of Our next from Newman comes question

open. line Your is now

Unidentified Analyst

good survival data the in curious [Justin was Hi, Valen] on John I still you FORWARD -- are planning Newman. XXXX morning. on for for This overall presenting on overall population? I, just is updated

Anna Berkenblit

analysis. So up at that to to survival ESMO August you FORWARD We seven -- from continued for hold trends change. saw which primary the overall expect six the we ESMO, over don't months data And updated to time. presented after was cut, at data an I initial about as

whether yet decided really getting our FORWARD will additional next data on for I year not because MIRASOL now have made not and is running. focus the or be presentations We up

Mark Enyedy

a data I survival to have this would some we'll And point, would the in journal. submit that at we updated point, that. at say,

Anna Berkenblit

Right.

Mark Enyedy

Yes.

Unidentified Analyst

on will And companion you scoring be just that utilize on the diagnostic, the will MIRASOL? diagnostic method PSX for working of a new

Anna Berkenblit

Yes.

Ventana of And X We is assay Ventana with The implementing And the with been working entire them will make us one used the the in that the and has way. with the we scoring Phase developed are continue program the Ventana. scoring studies sure earlier work in now development to with regarding the we PSX that the the become Phase in to we're X MIRASOL. assay CDx CDx. that

Operator

Markets. Thank question Capital our you. Kennen RBC And comes next from of MacKay

now is line Your open.

Kennen MacKay

X.X trial around or I you’re the design. years primary you just that just endpoint us so. clinical expectation that if a data past any and for support just that follow thinking on quick that the understand the that wondering, there's in sort from And of of of data enrollment was timelines opened in help Then wondering, had up could Maybe feedback previously sites timelines you the around if MIRASOL decision generation trial making? FORWARD the had helped I some I with of

Anna Berkenblit

Sure.

Remember, on of are track a the enrollment this end by the So year. is to XXX start trial. patient we

anticipate And in completing we so months. enrollment XX

into And readout us XXXX. which first the for middle patients top-line data to of primary So need is that that survival, and progression-free endpoint half into gets the then XXXX. of we gets follow us

enrollment And believe next that of months trial we the based rate. we recall in be faster XXX will we to trial. under and terms mirvetuximab, In understand patients now enroll that XX of initial that activity in a folks the that, enrolled largely on the sites, trial at able

working sites best the that are the We with in enrolled also I. have FORWARD

and that know are engaged most patient sites So we the the have population.

patients that population. medium And with that which that and focusing about is is are X on factor which looking offset in XX% about next longer the in I, to the is site XX% of of are will are excited single no say patients, discussed FRα-high however, One we've trial enrolling of FORWARD population. we that, one I we're Phase to forward that participate participated every every the them to MIRASOL. remember

a to we start the getting off quick So forward look ground.

Kennen MacKay

fact powering? FORWARD the using diagnostic powering that some I and a any biomarker there of much taking the new thinking just is came ESMO, the of at the other that very commentary for around make Thank is you are can design revisiting of Maybe the retrospective you questions. this you that the MIRASOL conversations in out data? How handicapping around look the or

ASH. at data to forward Looking

Anna Berkenblit

to was So, MIRASOL I hazard we target X.XX. designed recall ratio And may that targeting you a a of hazard FORWARD ratio X.X. have

we we looked trial. When had we X.XX, as a retrospectively, X.XXX, back actually say, we when X.XX, which ratio methodology FRα-high more the of a in-line with Now, I much saw at hazard ratio designed hazard the looked pre-specified we FORWARD a the at improvement how went PSX+ subgroup, okay? PFS you was and with saw about it, with

So what we're use data for -- the be PSX clear we've of X.X, a conservative I patient hope will a is we selection, taken would because the targeting given which MIRASOL for is MIRASOL using say that consistency the we rather I of approach hazard ratio is that trial. when what was in the it methodology that seeing, Is complex.

Kennen MacKay

to that. And thank maybe just subsequent a That you is much. helpful, very follow-up

confidence other at Just of different can and understand about biomarker, mirvetuximab this, I and this help were maybe that in the we looking this a examined? data? type were the as many data use FORWARD you have we trial can by what sort sort us you is many new think of sort Phase looking means design, retrospectively Was how retrospectively X biomarker examined used data? Because the different or how in the I meanings factor you other of FORWARD or much others didn't earlier of you but into there at only metrics you how of

Anna Berkenblit

FORWARD take first were did PSX+ And again went previously. with a as they call the thing back data selection look new we rescored say patient had it the we a biomarker the read we we the when and at used now. went and not was I back we that would done I PSX, way to would the a as not anticipated, methodology. strong I to really So we and hard out,

back are we're course with Of rose in entirely None to one previously the we endpoints of Frankly, we biomarker worked. to the them to going up those had come us FORWARD that new an interesting. and put data I exploratory biomarker. needing level knew of

Operator

of next Blair. William Andy our Hsieh And from comes question

open. Your is now line

Andy Hsieh

cohort. of about patient in the baseline about of platinum-agnostic baseline so So -- with characteristics prior think therapies, I'm enrollment should that experience, properties? we the terms kind treatment of the How talking completed all kind

Anna Berkenblit

Right.

platinum-agnostic So, forward presenting year. the cohort of we to look next from initial middle data

You may data that so patient are enrollment XX cohort in recall September, we completed in maturing. the

combination unlike platinum-agnostic. prior we cohort, the we In terms that patients enrolled, bevacizumab are what of these the call

have have recurred they than So in their to disease, platinum. they six not last other words, months platinum-resistant have could did after greater

there on six with to a months, interval. trial, physicians months, But I enrolled two look good a a mean interval nine of was appropriate distribution enroll. patients that XX at nine the some with of years. we with Those patients to who platinum-free When platinum-free actually would been intervals these not longer of platinum-based to not have slightly are patients another get platinum-free for typically then doublet.

will these maintenance, step. non-platinum patients getting next of say, is I aside are technically that and population are from the platinum-sensitive, evolving So regimen these really who better physicians are is tired. need who PARP a with there physicians they is and getting patients BEV bone as still And market landscape patients there's growing their because the platinum, -- appropriate evolving, doing marrow a maintenance are more and patients feel treatment feel and is the something

like lot a regimen really makes so And of plus sense. mirvetuximab a bevacizumab

Andy Hsieh

And back randomization it's the X:X, rationale that? now I before Is the to was behind noticed there the MIRASOL X:X. that FORWARD I design, going a

Anna Berkenblit

Yes.

So the earlier more with bunch is randomization was to rationale development mirvetuximab of the a of treat database. actually for size FORWARD the much that mirvetuximab X:X our I whole it needed patients and safety to in a increase we having

a many so mirvetuximab, a we treated which efficient patients safety statistical X:X actually we therefore database. more randomization with And robust Now, perspective. a moved have of have is design hundreds from to we've

Operator

our Biren Jefferies. question And with Amin from you. comes Thank next

Your line is now open.

Biren Amin

does mirvetuximab? differentiate that to Just IMGNXXX. How on

Anna Berkenblit

so alpha from we we scientists, given are sharing target, early FRα our to ability can go, activity. -- researchers next to about the have bind our address bystander And mirvetuximab, we in agent So ability targeted next next ability agent features things receptor make to better. really to know do of that the our can There basic what we data terms to focused folate generation year. that look year forward on even have next

features comprehensive benefit really are would patients the and generation we think all and there that of currently because may So we agent, targeted assessment of I things many we've are a that next benefit. it about done be the does FRα tweaked excited say nice can mirvetuximab not

it’s specifically with FRα expression. lower those So

And about that year. excited next so, we're

Biren Amin

some going IMGNXXX. at we’re And data have think I to then ASH on

cohort. you've AML BPDCN presentation expansion think and in done I oral potentially

XXX it that, doses the narrow the four those being So phase a little bit dose at about ASH ASH Anna update? Are highlighted four was maybe that still the can just across think oral after Did in last further into I you doses. year tested? an talk because during range expansion the went expansion phase you

Anna Berkenblit

Yes.

So at many ASH of terms have in both patients’ this year, over AML BPDCN. worth as data, we and will twice of

have we the this So year very optimal been schedule. working understand hard dosing to

choose recall year, QX last You a the that weekly move trial a data dosing with we of we've that’s from presented since dose additional as schedule schedule, running and may would up us that’s that we're week the the kg data and And into to mgs well schedule. allowed and venetoclax combination as azacitidine that’s and now. we IMGNXXX then in generated X.XXX per combining had

ASH. are also look We exploring forward data at and all the that week sharing level additional we QX schedule have one we additional the data get dose of to to

Operator

Jessica question Thank from Fye you. And our of JP next comes Morgan.

open. now is line Your

Daniel Wolle

Thanks Hi. This our question. for Daniel. is taking

Biren's should abstract with any on IMGNXXX? ASH we Following new question, the for expect data

Anna Berkenblit

this of year. twice last have with year over worth will many we data patients’ Yes, as compared

Daniel Wolle

Alright.

expect data So expect we be should new maybe at specifically the should or the more was the I just data abstract to we new presented in presentations? asking,

Anna Berkenblit

the earlier we year. So in enrolling we quite August abstract think and well were that had was we submitted used and I this all data the

will worth additional So and recent we the the data. data have patients’ at abstract have most then of will ASH

Daniel Wolle

one more. Got it. just then And

developmental recent that you the the thinking you XXX BPDCN, advances pathway the for indication? Given elaborate standard-of-care could guys are that of for in on in

Anna Berkenblit

Sure.

worked against ALL recently So Since aggressive therapies, and BPDCN no gotten there -- regimens particularly approved nothing specifically until BPDCN. have approved rare toxins is well. long-term very administration CDXXX very has diphtheria of ELZONRIS diphtheria where toxin hematologic Diphtheria SL-XXX a with some particularly aggressive making a however, Stemline our then, the targets challenges, physicians bodies in conjugate for AML for malignancy challenge. conjugate. making terms which used regimens, antibodies were It toxin

in a based the hearing despite they its said, small meet of frontline relapsed/refractory study approval of syndrome setting, physicians did approval are with the is capillary need as well That its liabilities patients to get on with because not setting. its a diphtheria leak the population. ability this being in of are from toxin, handful as in entirely that some satisfied What patients the of we unmet

So both relapsed/refractory the upfront post- an and setting. need, unmet setting the ELZONRIS remains in also in there

ELZONRIS Our patients. post- agent has BPDCN last year for the demonstrated activity already settings ASH at in

regulatory become we approval. bar we and opportunity we disease, potentially to accelerated based an So it the but rare given be, -- on think what potential data, we're here for of believe have would for really will precedent, have working nature we option be best-in-class. single-arm the And the us a on this for approval

Operator

Thank Leerink. question you. Chang And from our next of Jonathan comes SVB

now line Your open. is

David Ruch

on for Ruch is David This Jonathan.

to its the and on patients. back PARP Just on first go MIRASOL use question impact to

Specifically, or that of either XX% FORWARD PARPS result a in that PARP, predominance could patients of lines I you use later therapy? earlier a in do of of line earlier patients had given only think

Anna Berkenblit

know don't do, We predominance part. the about so I Yes.

Mark Enyedy

Right.

about with were particularly at deficiency. that, that you And recombination homologous those of ESMO, what you at BRCA from look if patient think you is when here population just the inhibitors those half segmentation you I second, you with population. totality profound mean So, to the for maintenance of about when PARP the patient see patients get a activity though in that the published mutations, add and up, setting, data the

inhibitors wild-type HRD-negative using benefit clinicians balancing I PARP be there. going to is -- think and are inhibitors patients patients there PARP the BRCA The benefits of the or risk

of at on inhibitors. to do from think of going patients, half we too, PARP helpful? our the activity inhibitor studies an and some prior early Is And prior not combination XXX, patients. the treated you're those having PARP patients only in the see we the using in used -- as impact look I don't see or PARP when of have, but we PARP data safety I see line So that now it say, that mirv we that

David Ruch

to That's helpful. is could And Yes. that appreciate MIRASOL see we in that. stratified really something the I study? expect

Anna Berkenblit

consulted stratification prior study, stratify BRCA the in of KOLs, of therapy our around and MIRASOL choice a PARP and not So should for lot matter. specifically whether there lot We've that or factors chemotherapy. you can HRD lines a use have for and or of or stratify. Europe, we do discussion that I we ultimately assure of not mutations both to in the U.S. decided we was

Mark mentioned, a XX%, patients As expect we prior have XX% of PARP. maybe to

and think they that, balanced subset plan And to be that we will our able analysis of in statistically will So to do look important will analysis appropriately. be an statistical that speaking, an we we pre-specified course, be at.

David Ruch

this around Second of asked the with Could but yet. versus question assessed additional FDA, I investigator specifically them was is any really you about on essentially on the use last hadn't the read discussions think call, you met quick. with color provide just criteria? the

kind what to their was to response wanted just So confirm of that?

Anna Berkenblit

opportunity did we investigator agree the primary acceptable that MIRASOL. assessment an FDA elements and is to Yes, key had the PFS for endpoint by they discuss with design

necessary the audit, review we hold So the analysis now for independent well. and for blinded, any sensitivity as scans recollect

David Ruch

in players And one you do from view XXX CDXXX How the from as other space? the last some me. differentiated of

Anna Berkenblit

antibodies about against some and a with already capillary it. generated conjugate talked leak bit diphtheria liabilities we including toxin ELZONRIS, a little being So

So that's one.

some The compounds in other CDXXX. include are bispecifics that towards development

the have And as MacroGenics’ CAR-Ts every CAR-T. challenges patient. example, there some work, cytokine bispecifics, release. for For they activity These there. they're some for need sure like infusion terms is they have work targeting are the Then Flotetuzumab. and in know, durations you And when there reimbursement and challenges and for Bio the of long CDXXX CAR-Ts Mustang not they beautifully

I intravenously clinic a infusion brief directed real think the in ADC as some our advantages. IV CDXXX has that's given

there. you of different color out agents So sense of that gives the the a

Operator

Thank you. [Operator Instructions].

of from Securities. comes Schmidt Guggenheim Michael next Our question

Your line open. is now

Michael Schmidt

it's in any a wondering I was had just the with I FDA but first of Maybe regarding trial if was you interactions to wondering had BPDCN, requirements. couple early already respect know if I IMGNXXX. on -- program, I still the pivotal kind

-- for submission? For of example, what for would patients required, data BPDCN be many worth how example,

Anna Berkenblit

we No, not discussed have FDA this with yet.

Michael Schmidt

would Okay. label newly for sure. into I'm patients think not both, XXX% Stemline go you may I relapsed/refractory initially the And but have a product BPDCN? on diagnosed

Anna Berkenblit

and those Yes, a subsets they considered label patients of has had response of for what CR/CRc. one was in relapsed/refractory two setting Stemline both, out in it to the XX a

So but it CR/CRc rate I the is In the their was setting, in think the quite a relapsed/refractory low setting. frontline higher, again bar group was small of patients.

actually are for we allow available study are standard-of-care amending in the to process our who therapies. of So frontline patients unfit

about engage what good really for approval. raised take would looking a discussion and to gathering you a will So point, on we're enable have to it us with that FDA forward proof-of-concept data able --

Michael Schmidt

be BPDCN Okay. the how with included ASH And patients many update? will in

Anna Berkenblit

many twice as last were Over year three. as last there year, and

Michael Schmidt

should Vidaza patients, frontline? opposed The the to relapsed/refractory agents potentially in AML we as patients of activity other been they've talk rational after about little a in bit these question previously how think already had, And about I and just with combination? maybe Venclexta to XXX in combine used

Anna Berkenblit

Sure.

Vidaza So study, the And dose not cautiously, unfit is escalation starting when be because patients. we're for off easy relapsed/refractory somewhat an say, would population. necessarily the part just regimen I of in we're will the beginning

move the be triplet. basic venetoclax XXX plus then azacitidine. will established we've will of to once doing we doublet we doublet of And safety, XXX and So plus

the certainly, physicians first But we be the up triplet have ultimately, patients so initially we'd that appropriate data an interested will therapies those frontline each choose they in generating into And had doublets for of will previously. be population. in that setting, start this but moving based safety to on

Michael Schmidt

X how guess set you’re data we should Understood. -- move the substantial at about just think I year-end. for Phase pivotal having And studies then bar efficacy XXX a looking potentially into by to potentially? quite this

Anna Berkenblit

what and doing around that XX%. data relapsed have with the we've data in MRD-positive and the I XXX at is activity bar we CR really would ASH the monotherapy setting the relapsed/refractory the has set we'll sharing in nice is, say monotherapy just for So a is be far opening or up thus monotherapy we're combinations. based opened on as the study an seen we're cohort rate

MRD patients cohort therapy we are residual do are but this now minimal they well. induction disease not And NCR, had have patients those So know very AML who present. positive do and

to So that, we patients. MRD-negative and up the convert cohort, with opened ability will benefit ultimately of again, IMGNXXX could from to that really looking idea that a we just is be monotherapy the at have it enrolling, patients MRD-positive

that is advancing monotherapy potentially. So option another perspective registration a from for

Michael Schmidt

And be patient with alternative relapsed/refractory there an positive this to or population, at indication a...? would labeling MRD

Anna Berkenblit

It's That's another right. option.

Michael Schmidt

guess MRD-positive that patient the subset? is and the potentially, of what I AML -- population size

Anna Berkenblit

I Again, to XX% the that, is back on it about get subtype of on to but who what the would bit into molecular of it a go CR. patients have you AML is. depends little

Operator

from you. Catanzaro Thank of Piper question our comes And Joe next Jaffray.

Your open. now line is

Joe Catanzaro

I just review wanted investigator on assessment. to versus follow blinded the up central quickly

blinded look and go ratio ever from for central ticks up PFS to you So when at if investigator, review PSX hazard we rescoring the slightly. the so

are are it Is is to there were assessment MIRASOL? simply the considered what other use considerations that wondering being quicker? there? just So your things for turnaround Or time investigator

Anna Berkenblit

Yes.

the is what I So blinded, gold few that an has own shift assessment toward is real it previously that would its things be there But review patients. are there’s understanding was a life the being use of typically standard. in there set day-to-day say, independent Investigator of having considered. now a treatment their biases. investigators

a from is move that primary And be so the endpoint. be required to away having there

study required may see review scan, One fact blinded, in entry. independent see measurable is of The necessarily for investigator that the not may it's independent issues the with that. review blinded, on disease the baseline

makes that challenging overall then response to cetera. et at look so And it rate,

I out we hazard the smaller Remember X.XXX sizes of the of to would that these pointing patients X.XX. difference FRα than say ratio you're had a sample about in expected because because lower versus exclude is expression. like are third that [post-tox]

have some hazard is study the data these of or there say some that X.X would I the in But are the wobble both ratios we set. So well for. below designed remember, noise

Joe Catanzaro

one. last one just then And

platinum-sensitive far, think only combinations combinations a you the considering, Is at one other you're the this other explored can it seems If time? PARP obvious combination to is about are approach you thinking you're that mentioned you that about explore. combinations So, that inhibitors. like thus disclose there have we

Anna Berkenblit

Yes.

data IST an would with From targeted alpha heavily for there carboplatin inhibitor. PARP rucaparib a strong generated doublet mechanistic view, with receptor point biological data rationale for mirvetuximab ongoing a suggesting I is the and therapy patients. there quite mirvetuximab of data that active. a perspective are The So that folate triplet combine and in, are was no have Those published have initial pre-treated with a these regimens we to combining say, with the proof-of-concept now we bevacizumab. clinical preclinical is and from

platinum-sensitive that So for the are ones on the further development those we're focusing in space. have prioritized and

Operator

this over Thank does you. for And ladies and conference closing Enyedy back Mark like session. gentlemen, I now conclude the question-and-answer to to would our turn remarks. any

Mark Enyedy

restructuring We’ve the June, on in looking a After to forward. strong Appreciate and finish ImmunoGen you this moment really momentum in productive your year a difficult and to put the forward XXXX. very the a business, are business we've Thank built a path time much. morning.

Thanks look And ASH in seeing at so of mentioned all you as again. many to we December. forward, you

Operator

concludes conference participating. this gentlemen, and Ladies call. you for Thank today's

may now disconnect. You

Immunogen (IMGN) 1 Nov 192019 Q3 Earnings call transcript