joining for today. everyone you Thank
of between XX-K a was compressed that call preliminary recent given the the of the was focus quarter the just trial. results and annual quarterly filing ago, release FOCUS XX-Q. typical month The from first last call Our over the the timeframe
just I the believe of results FOCUS success endpoint, a data review the We for trial margin. response checkpoint threshold exceeding treat the ITT a demonstrate metastatic the used some powered call. misinterpretation by is the specified data, are investors the for the the lower frankly to superiority this greatly recap demonstrate pre-specified the wide warranted rate preliminary results; primary of superiority was the an which inhibitors in and positive. of by Given the overall over the as pre exceeded exceed melanoma. in XX%, study very on lower to committee overall of XX.X%, rate by ocular unambiguously bound those bound importance over population rate to regarding importantly, determined X.X% response independent We threshold the reported X.X%. Most needed To response of overall The success.
impossible it mathematically to of regardless the treated While the on calculation our of the bound of XX% is patients, outcome is for of the response of base results patients. based have Success patients. efficacy the response and cannot have Criterion few X.X% the below lower fall data the We point overall can remaining these rate end that met change regardless this data, state, we based unequivocally pre-specified on remaining pre-specified of
a for nine in disease patients was Alternative XX.X% Alternative advantages versus Alternative used alternative over Care the for statistically checkpoint small with have inhibitors signal analyses in HEPZATO rate may m XX.X% progression Best not the Care comparative Best may response and demonstrated were the HEPZATO the TACE. free patients. including overall care rate, survival the HEPZATO melanoma, and inhibitors This both the was Care X.X XX.X% arm survival, pre-specified months of treatments the arm represent versus checkpoint disease for median HEPZATO for rate, provides strong was control In of Additionally, for of control bulk the for result meaningful rate arm minus metastatic Care of that trial clinically the the Since given a Best the the care metastatic patients. current overall expected arm. in ocular months the best alternative arm, response against and population, utilized all the XX.X% improvements. was arm, and and significant best the trial This most TACE TACE metastatic treating for treatment ocular arm Since HEPZATO progression care standard free the Best these melanoma in data becoming protocol melanoma arm. Alternative per versus and the
against we change significantly results full these preliminary comparative data the preliminary, data these care best are upon evaluation not confident are alternative While will set.
pivotal profile objective conducted safety More trial FOCUS related critical center medical to of safety our European of in population with different treatment the consistent CHEMOSAT in A while no improving single patient safety was signals seen of treatment efficacy the previous and in dramatically or device profile multicenter a observed the deaths. with and the new trial profile. with improve was no maintain procedure, earlier safety version this publications, described the importantly, the
We have clearly demonstrated that goal.
virtually, that We oral trial as X results FOCUS be will presentation presented at Oncology to of meeting, the X. will be Society an which the are annual June Clinical held American excited
the broader June Time which have the on a to Monday at X:XX may hold Eastern Q&A community will answer AM investment any results. regarding We questions X webinar
important this is to that are that in of CRL or Medical It from FDA the keep related ESMO efficacy the And that we of We received not data that meeting, projecting currently was as Society demonstrate XXXX issues. safety September or medical the due system. by in the such PHP summer, the been Complete largely Response at not have or for a Oncology, trial to our in determined. European or Letter release September to final is multicenter we end second sooner whether yet the large mind
this did of indeed safety. that the improved we system modified both the PHP on Based at have While an safety clearly require improved FDA results version that CRL, procedure the again, the prior device the clinically the of developed company system and demonstrate these improve procedure. associated results efficacy time with the procedure, or had we
We have modules we final caveat Europe. access to XXXX compiling to NDA still the the due clinical all the to away, data depends are quarter item our The on log mandates, despite sites. access, but started targeting with which still this primary restricting especially the are site various is of that of months being still first the some submission requires gating sites access monitoring, in COVID database and
sites, last should can we do we will sponsors that. may creating Timelines site days. accelerate but endeavor on launch. additional As get are to by sites to shift, most we to shift, open days do trying other up uptake like upon be all on catch of If market which incremental avoid value number to timelines still we the expanded access increasing will monitoring
program Trial complete, melanoma treatments. expanded initiated formally metastatic access for enrollment is to FOCUS anticipate patients receive HEPZATO and we the Now ocular
melanoma, indication conditions, need, have metastatic indications treatment strong since are While are we worthy high strongly of believe metastatic is evidence in we confident we and intrahepatic in unmet metastatic utility the there there or good have an these an level ICC PHP options. few we beyond have already note well a in some cancers where cholangiocarcinoma, are orphan colorectal for approvable melanoma ICC that with efficacy should of ocular therapy treatment and
from patients. approximately efficacy We usage signals in commercial strong of in XX have Europe
over pause improvement in slow a to have the provide due believe pursue need to data current While may trial we we this PHP that given the clinical meaningful and should we existing indicates ICC enrollment, indication continue unmet that options.
appropriate recruitment are We recruitment. scheduling increased the advisory now which awareness as will rates, expanded well as with among which oncologists enable investigators, access both site boards design should enable protocols,
cancer, leverage isolated publications from In hepatic a surgical results referred terms to reporting of perfusion, we a procedure in clinical signal as IHP. or existing can colorectal
these largest treat its in surgical the the into is two veins with IHP has in of Over abdominal circulation is chemotherapeutic metastatic which been route liver extra by repeatable. surgery cancers, variety delivered an invasive and agent to arteries circuit common doses, demanding order blood relatively chemotherapeutic very which to canyons an procedure it corporal melphalan. in utilized most from is is more performed colorectal isolated at not agent placing or the high in vessels being centers, of IHP and past few multiple given the numerous open and the a major is and the the decades in
Over the with in patients past documented results have rates response XX%. decades, eight two to metastatic XXX publications well colorectal XX% ranging over
meaningful direct patients bearing XXX results dominant metastasis. for eight have percutaneous isolated warrant patients and the believe mortality than would not ocular strong hepatic if thus the likely essentially are might offer was for types was morbidity a HEPZATO from from and melanoma, suffering disease replacement on initial perfusion, repeatable surgery. liver a far fold. associated other multiple more option expand which PHP technique colorectal XX with tumor results widely the HEPZATO likelihood market less these the documented studies published could and And metastatic for ICC it results, or Given invasive, hepatic significant surgical we addressable alone from have the this would that target colorectal there patients and used, a with investigation.
a look the well on to protocols later through ICC, in setting forward consulting other We study reporting engagement the midway possible to are as assess related indications. and to We colorectal, as that appropriate year.
continue our design to commercial for strategy. we As we prepare our FDA submission, launch
our of organization, the strategy of efficacy and for size We are treatments, our commercial pricing assessing and reimbursement. the competitive coding,
of the In with to KOL enlisting treatment to specialized treatment specialize a This focus approximately advisory team. ocular US consulting centers we clinically is If melanoma, to of rarity will on firm the the with approved, metastatic metastatic most ocular responded ocular costly launch seek represent tune melanoma number small most commercial combination agents. meet of treatment the XX melanoma Currently with boards these HEPZATO of market assistance Delcath significant the in commercial documented advance a of that prognosis needs centers of melanoma. a strategy care well are in our community access. team, metastatic it the a patients the will has us but the melanoma and in immunotherapy across melanoma known help allow treatments. fine regimes modest begin ocular addition Because not medical melanoma. commercial Ocular of as of the well to of ocular and well one
be treatment HEPZATO immunotherapies compete of pricing current should the that options. comparable Given to
HEPZATO outpatient designed are be the accordingly. While access market and used setting inpatient our and will in plans being both
will upon rapid Our among launch. to procedure. the to are Most this outpatient anxious HEPZATO investigators US HEPZATO indicated get access experienced be an with well for which the in consensus uptake physicians involved bodes trial has outreach that a predominantly importantly,
the been categorized NICE has nor patients private of national United changing be was as a for Previously, the regional treatment commercial NICE critical NICE CHEMOSAT, with Delcath. and National important be with under the start past a -- available seek this may designation. Institute to be national better months it a CHEMOSAT melanoma. guidance Excellence, guidance to coverage. particularly and the to Another transformation and Under insurance now of CHEMOSAT process for were for metastatic known CHEMOSAT Kingdom's not insurance formal regional recommended is development CHEMOSAT available six some both private may The treatment context revised designation, possible been Health reimbursement. fund in studies. used of apply have of more the guidance, funding only in research marked for has to not Due the arrangement guidance, for Care likely more the can Under that funding special generally accessible,
results. benefit we of both attracted year, but as perfusion call prepare We which to most have Delcath high areas the to the strengthened to need. the is first the importantly, practice early quarter team, look NDA this from in of first file Christine earlier compilation preliminary turn ratio proprietary the taking management hepatic a an new HEPZATO percutaneous generation HEPZATO system. to significant in FOCUS to and of risk continued balance into I the and questions, we'll additional unmet strongly XXXX review investors, time, financial improvement results an versus that progress the expand forward as indicates over trial forward During released we look of
