PI3Kδ Tus Txhuam Hnav ME-401 Muaj Tsim Nyog Tau Txais los ntawm Asmeskas Kev Tshawb Fawb Hauv FDA, Thiab Tag Nrho Cov Nyiaj Them Nqi Kho Mob Rau 3 Hom Mob Tawv Loj yog 75-100%

MEI Pharma yog ib lub tuam txhab kev lag luam kho mob biopharmaceutical lig-theem mob siab rau kev tsim kho tshiab rau kev kho mob qog noj ntshav. Tsis ntev los no, lub tuam txhab tshaj tawm tias Asmeskas Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) tau tso cai rau nws qhov ncauj xaiv phosphatidylinositol-3-kinase inhib (PI3Kδ) inhibitor ME-401 ceev ceev kev tsim nyog (FTD) rau kev kho mob ntawm kev txais cov neeg laus muaj feem rov mob lossis refractory follicular lymphoma (R / R FL) ntawm tsawg kawg 2 kev kho mob hauv chaw.

ME-401 yog kev kawm txog qhov ncauj phosphatidylinositol 3-kinase (PI3K) delta inhibitor. PI3Kδ inhibitors feem ntau muaj ntau nyob rau hauv qog nqaij hlav cancer thiab ua lub luag haujlwm tseem ceeb hauv kev nthuav dav thiab muaj sia nyob ntawm cov qog ntshav. ME-401 qhia tau xaiv qhov siab rau PI3Kδ subtypes, thiab muaj cov tshuaj sib txawv los ntawm lwm tus PI3Kδ inhibitors. Cov tshuaj muaj peev xwm hloov ua qhov zoo tshaj plaws-hauv-PI3Kδ inhibitor. Nws cov yam ntxwv ua pov thawj tau qhia tias yog kev kho tus mob monotherapy lossis hauv kev sib xyaw nrog lwm cov tshuaj tua kabmob kheesxaws, nws muaj lub sijhawm los daws teeb meem ntawm B-cell malignancies. Tam sim no, MEI tab tom ntsuas ME-401 los kho cov neeg mob uas muaj ntau hom B-cell malignancies.

Kev khiav ceev nrawm (FTD) yog tsim los ua kom muaj kev txhim kho nrawm nrawm thiab tshuaj xyuas cov tshuaj rau cov kab mob hnyav los daws cov kev kho mob tsis txaus ntseeg hauv cov cheeb tsam tseem ceeb. Tau txais cov peev txheej nrawm nrawm rau cov tshuaj sim txhais tau tias cov tuam txhab tshuaj tuaj yeem cuam tshuam nrog FDA ntau zaus thaum R& D theem. Tom qab xa cov ntawv thov kev lag luam, lawv tsim nyog rau kev pom zoo nrawm thiab kev tshuaj xyuas ua ntej yog tias lawv ua tau raws cov qauv tsim nyog. Ntxiv rau, lawv tsim nyog rau cov ntawv tshuaj xyuas.

Tam sim no, MEI tseem tab tom soj ntsuam thoob ntiaj teb theem II TIDAL kev soj ntsuam los soj ntsuam ME-401 raws li kev kho mob rau cov neeg laus R / R FL uas tau ua tsis tiav tsawg kawg ntawm 2 cov kab mob kev kho mob (suav nrog tshuaj kho mob thiab cov tshuaj tiv thaiv CD20 tiv thaiv) tus neeg mob. Cov txiaj ntsig kev sim yuav siv los txhawb nqa daim ntawv thov rau kev tso cai sai ntawm ME-401 mus rau Asmeskas FDA.

Ntxiv nrog rau kev sim TIDAL, MEI tseem tab tom ua ntau daim caj npab, qhib-daim ntawv lo, theem Ib koob nce thiab nthuav kev sim kom ntsuas me-401 raws li kev kho mob monotherapy, hauv kev sib xyaw nrog lwm cov kev kho mob (xws li rituximab) lossis tshuaj (Xws li raws li Brukinsa [zanubrutinib, zebinib], Baekje Tuam Tshoj BTK inhibitor) kev kho mob ua ke kom rov mob lossis rov kho tus kab mob B-cell malignancies, suav nrog cov kab mob follicular lymphoma (FL), mob ntsws lymphocytic ntau npaum li cas / mob cell me lymphoma Tumor (CLL / SLL), mob qog ua kua qog nqaij hlav (MZ). ), mantle cell lymphoma (MCL), diffuse loj B-cell lymphoma (DLBCL).

Lub Kaum Hlis xyoo dhau los, MEI tshaj tawm cov ntaub ntawv kho tshiab ntawm Phase Ib txoj kev tshawb nrhiav. Cov txiaj ntsig tau qhia tias tag nrho cov kev kho kom rov qab (ORR) ntawm txhua pawg neeg mob (FLL {{0}} CLL / SLL) kho nrog ME-401 yog 75-100%, tshwj xeeb: (1) ORR ntawm txhua tus neeg mob FL yog 78 % (n = 43/55), ORR ntawm ME-401 monotherapy pawg yog 79%, thiab ORR ntawm ME-401 + rituximab ua ke kev kho mob pawg yog 75%. (2) Lub ORR yog 89% (n = 16/18) nyob rau tag nrho cov neeg mob CLL / SLL, ORR yog 100% nyob rau hauv ME-401 monotherapy pab pawg, thiab ORR yog 71% hauv ME-401 + rituximab txoj kev kho ua ke pab pawg.

Hauv txoj kev tshawb nrhiav no, ME-401 kev noj tshuaj ntau zuj zus (CS) thiab cov tshuaj noj tsis tu ncua (IS) tau qhia txog kev kho mob siab thiab kev zam ntev ntev hauv ob qho tib si FL thiab CLL / SLL cov neeg mob, tab sis ME-401 tau soj ntsuam hauv IS regimen pawg. Qhov xwm txheej ntawm kev kho mob ntsig txog qib 3 qhov tshwm sim tsis zoo yog qis dua hauv pawg CS regimen. Piv txwv, qhov tshwm sim ntawm qib 3 mob plab / mob plab yog 5% hauv pawg IS regimen thiab 23% hauv pawg CS regimen.

Thaum Lub Kaum Ib Hlis 2018, BeiGene thiab MEI Pharmaceuticals tau mus txog kev sib koom tes tsis yog kev soj ntsuam kev koom tes los soj ntsuam cov peev txheej ntawm ME-401 thiab Brukinsa los kho B-cell malignancies. Lub sijhawm tam sim no, ME-401 + Brukinsa kev kho ua ke ua ke tau muab tso rau hauv kev sib koom tes sab saud, qhib-daim ntawv lo ntawm Phase Ib kawm los soj ntsuam qhov muaj peev xwm ntawm kev kho mob ntawm FL, MCL, thiab DLBCL.

Brukinsa (Zebutinib, zanubrutinib) yog BTK inhibitor los ntawm BeiGene. Nws tau pom zoo los ntawm Asmeskas FDA thaum lub Kaum Ib Hlis 2019 rau kev kho mob ntawm cov neeg laus mantle cell lymphoma (MCL) nrog tsawg kawg ib qho kev kho mob dhau los. tus neeg mob. Nws yog qhov tshwj xeeb tshaj yog hais tias Brukinsa yog thawj cov khoom lag luam tus kheej pom zoo los ntawm Baekje Tuam Tshoj kom tau npe nyob rau hauv kev ua lag luam, kos cim lub cim tseem ceeb hauv cov tuam txhab kev txhim kho, thiab tseem cim thawj tus qauv tsim tag nrho los ntawm cov tuam txhab Suav. Cov tshuaj tshiab los tiv thaiv mob qog noj ntshav pom zoo los ntawm Asmeskas FDA tau ua tiav" rau cov suav suav tshawb nrhiav tshuaj tshiab.