accomplishments on thought call were a I'd one the keep that ASH company. and week. for morning. of try and of after goals short. and then focusing ago, just Seeing year's released provide on touch some relatively color those catalysts to major a Great. upcoming as this Thanks, Q&A for Sean, joining around the conclude, some and last on to presentations, by we're this little this thank I'll you, and everyone, weeks I a thanks, few abstracts and we going context bit start the Jenna, we out us with
start, to about ASH X the presentations last announced So in talk week. that let's we
UX First together, is our chronic CKX lymphocytic antibody, selective with our umbralisib, leukemia, in to relapsed we the an and delta or plus CLL. monoclonal refer presentation triple ublituximab, oral on combination patients UX, which anti-CDXX and inhibitor; as PIXK glycoengineered highly of so also refractory venetoclax, Epsilon
plus time the frame UX in This venetoclax is intent of could with a designed deep was assess drive durable to treatment. I/II potentially whether responses and fixed Phase study a
of in example, Natcat. in And was treatment that ibrutinib. of the stop exciting bone included tidbits achieve if We induction. are alone highly then patients With and patients, that XX alone patients a MRD-negative to with refractory study, prior a XX%, after in of them XX again, few X relapsed/refractory A these For of to this you cycles the an UX start marrow. abstract months overall XX introduction and number rate this and therapy, were response active. who heavily the pretreated, UX CLL is, are including of
time had combination. the follow-up Following or X response had submission to all was cycle the at the the venetoclax at partial abstract least drug X, study of X introduced X of that to complete ASH and a patients cycles
As marrow, the follow-up submission, blood the treatment MRD minimal and able in the end of to patients patients had of abstract the disease XX. undetectable or were them importantly, at achieved X of all achieved the XX X at those stop cycle ASH of bone and peripheral undetectable residual with in the X of of time had cycles
Clinical Trial longer at over of presentation results presented from Center existing numbers, the and of including to follow. at at represent effects, Institute these dramatic ASH, University these While Rochester. ASH will look to improvement Wilmot Bar, data therapy. patients at small these to Paul these Cancer data substantial Dr. a appear longer confirm study this are additional Director additional patient the through the patients We by To forward the be with
both II Additionally, at we hope V plus have study already registration-directed of the the what Center relapsed/refractory in CLO by This the combination CLL and Wild the led a looks single-arm Phase Cornell called Medicine be He's at in Research study is which Ultra Director in being York of Richard begun Dr. venetoclax UX patients. enrolling treatment we study, naive City. will Furman. here New
novel poster UX fractory sale of the abstract B-cell second combination as accepted of relapsed for I for a a Phase is The our agent inhibitor variety X,XXX, and a with malignancies. TG in with study BTK patients presentation
Lancet combination recall, where published response possible. was proprietary safety profile. The ibrutinib, marginal have in promising rapidly in the may move you with UX our hematology combination Casarino of study, the to BTK us we well-tolerated a a patients motivated XXX% results plus demonstrated seen we As as previously inhibitor as UX CLL into rate and with triple once-daily which lymphoma, in studies studied zone triple
and complete achieved zone triple The including a the the one haven't levels. response includes abstract agent response ASH the one in lymphoma dose the inhibitor, in X a assessment, patient on well at of partial combination dose single cohort the follicular follicular patient the seen in BTK and at first with in And patients lymphoma. responses, with as data data clinical from lymphoma a a our marginal at triple with as have TG-XXXX a patient includes Responses UX. lowest and treated all all cohort first ever combination
the in all trials enable month. Orlando those is top as novel patients nor treatments. to we have alone these excited mission or but of to will UNITY-CLL combination study in Both when both proprietary please the TG, triple are conducting a solution. that understand next Needless significant strategy position a particularly of to are say, develop a BTKS agents venetoclax be This UX ASH venetoclax at will puts the in come those forward the alone into therapies important BTKs for we're us on and also TG first pivotal combination to that is better need. candidates. the to hopefully as you to Neither conducted step optimize data, the used represents today drug it in studies go and study for we Meeting our that focus This
hinges better those Our get should of the stock patients good CLL all abstracts work. this so belief that, that positive UNITY-cLL patients long-term X a UX to time these outcome. the enhance and on the to durable can the of treatments With number much probably study of of remissions, is excitement it's a therapy. goal makes That as transition to is
relapsed/refractory chronic patients study a a control a monoclonal is leukemia. antibody the of reminder, randomized naive UX with of to combination of treatment UNITY-cLL As a chemotherapy anti-CDXX in Phase as active trial an well both as and an arm III lymphocytic compared
primary survival. endpoint trial for this progression-free The is
next from hope said we this or the study around quarter results have we year-end As of into year. previously, have to first
it this is PFS of predict an challenging a the timing study precisely as prospects successful completion. remain outcome. and the optimistic extremely However, the about We trial, event-driven to for is
rate, another highlight teriflunomide. let full course, we a of endpoint comparing relapsing ublituximab III that reading for also That, study III multiple for submission our primary relapsing reel so we've forms what in is Phase of two year annualized MS. approval remind in addition accomplished have out one trials I me sclerosis. Phase ublituximab of support of relapse quick These each data, two are and to XX of following weeks UNITY-CLL large to program III transition treatment designed in ultimate trials in of Before Phase are far, is III independent oral and Phase to everyone this the The XXXX. to forms
been under These FDA are now. the enrolled have with assessment for protocol year conducted over fully trials a special being and
trials top in middle from targeting year. second We line are next these to of data half the
times progress already forget ahead But TG. all exciting sure, for this the let's we've not year. For made
that primary met received remarks with with finish marginal FDA recap first this little the year, a major our XXXX. endpoint, in we the me of Earlier prepared and the three cohort breakthrough a announced my studies, UNITY-NHL Let indication. for Zone we quarters its designation for achievements lymphoma registration-directed the from
positive presented important appears Soon well-tolerated overall with demonstrating complete a at we XX% and for a embolism as XX% monotherapy be safety a conferences, approximately what preliminary rate to medical response few profile. an approximate response thereafter, data rate
such target meeting, Later, met intention year-end. announced announced module the with we commencement we around our And a NDA rolling to submission filing. after FDA of the one we a discuss lymphoma to that
combination - X demonstrated follow-up, of with we in high-risk years refractory monotherapy progression-free that ublituximab, study patients relapsed our survival CLL. announced Then GENUINE almost that in almost with ibrutinib ibrutinib, improved with over
lymphoma accelerated taken the follicular recent medical plan future cohort a to from weeks replicate results this conference. approvals, the lymphoma lymphoma to share approval data follicular need, discuss K ago, met high ranged endpoint for unmet is follicular XX%. deltas. short to its success to announced of an with from study goal PIXK accelerated with medical our and finally, FDA in data UNITY-NHL and overall We And successful target the for response of Despite primary two the by FDA at The XX% also other response Overall designed of initiating Delta our range pathway this the a that cohort population XX% with compared has patient approval remains approved our we for was PIX present these the XXXX. XX%, to the filing just was rate.
a our company We transformational to data potential for turn will to of before session, our XXXX, and II we the a lymphoma the XXXX to make zone marginal begin for With UNITY-CLL into year following MS. approval into has umbralisib I momentum over plan which which the be the going return the been with Phase and substantial concluding remarks. ultimate to us, transition pivotal year-end. commercial readouts that, our conference keep and X believe to we trials year organization with for operator I'd some an will call like for Q&A exciting
