Ntau tus kab mob myeloma (MM) yog ib qho mob hematologic malignancy, thiab MM suav txog li 1.8 feem pua ntawm tag nrho cov qog nqaij hlav thiab 18 feem pua ntawm tag nrho cov kab mob hematologic malignancies hauv Tebchaws Meskas. MM feem ntau tshwm sim hauv cov neeg laus hnub nyoog 65 - 74 xyoo, thiab hnub nyoog nruab nrab ntawm qhov pib yog 69 xyoo. Xyoo 2020, muaj 32,270 tus neeg mob MM tshiab thiab 12,830 tus neeg tuag hauv Asmeskas.
Tshaj li 20 xyoo dhau los, kev kho mob ntawm ntau yam myeloma tau ua rau muaj kev vam meej, suav nrog Johnson & Johnson tau tsim cov tshuaj proteasome inhibitor Bortezomib thiab CD38 mab Daratumumab, thiab ntau cov tshuaj tau dhau los ua qhov tseem ceeb ntawm kev kho tus qauv rau cov neeg mob MM. MM tau coj cov nyiaj tau los loj rau Johnson & Johnson, nrog Daratumumab ib leeg rhuav tshem $ 6.1 nphom hauv cov nyiaj tau los hauv 2021.
Vim tias qhov siab ntawm malignancy ntawm tus kab mob MM, xws li proteasome inhibitor (PI), tus neeg sawv cev tiv thaiv kab mob (IMiD), lossis anti-CD38 mAb tsis tuaj yeem hloov pauv qhov tshwm sim ntawm MM rov qab los. Qhov tshwm sim ntawm Carvykti (West olense) tau hloov kho cov qauv ntawm relapsed refractory MM nrog cov ntaub ntawv tsis zoo ntawm ORR 97 feem pua thiab sCR 67 feem pua. Cov nyhuv curative yog qhov tsis txaus ntseeg, thiab cov nyiaj tau los ntawm nws kuj tseem ceeb heev. Raws li lub Cuaj Hlis 30 ntawm lub xyoo no, raws li Legendary Biology thiab Janssen Biotech, Inc.(Janssen) Kev koom tes thiab daim ntawv tso cai daim ntawv cog lus tau nkag mus rau lub Kaum Ob Hlis 21, 2017, thiab Carvykti tau tsim kev muag khoom muag ntawm kwv yees li $ 55 lab.
Teclistamab ua haujlwm zoo npaum li cas?
Teclistamab tseem siv tau rau cov neeg mob uas tau txais kev kho ntau hom kab mob. Nyob rau theem MajesTEC{{0}}I-kev kawm, 165 tus neeg mob ntawm rrMM (xws li PI, IMiD thiab anti-CD38 cov tshuaj tiv thaiv) tau kho ntawm 1.5mg / kg ib zaug ib lub lim tiam tom qab tau txais koob tshuaj ntxiv ntawm {{9} }.06mg / kg thiab 0.3mg / k g. Thawj qhov kawg yog qhov kev tso cai tag nrho. Lub sijhawm nruab nrab ntawm kev soj ntsuam yog 14.1 lub hlis, tag nrho qhov kev tso tawm tag nrho yog 63.0 feem pua, lub sijhawm nruab nrab ntawm kev tso tawm yog 18.4 lub hlis, thiab qhov nruab nrab tsis muaj kev vam meej yog 11.3 lub hlis.
Hais txog kev ua tau zoo ib leeg, Carvykti zoo dua me ntsis. Txawm li cas los xij, Teclistamab muaj kev nyab xeeb dua piv rau CAR-T. CARTITUDE-1 txoj kev tshawb fawb pom tau tias cytokine tso tawm syndrome tshwm sim hauv 95 feem pua ntawm cov neeg mob tau txais Carvykti (4 feem pua qib 3 txog 4 feem pua), immune effector cell-associated neurotoxicity syndrome yog 21 feem pua (4 feem pua qib 3 txog 4 feem pua. ), thiab rau tus neeg mob tuag ntawm kev kho mob cuam tshuam txog kev phiv. Qhov tshwm sim ntawm Teclistamab cytokine release syndrome yog 72.1 feem pua (xws li 0.6 feem pua , qib 3; tsis yog qib 4), immune effector cell-related neurotoxicity syndrome yog 3.{{20}} feem pua (ob qib 1 lossis 2), thiab lwm yam teebmeem tshwm sim yog neutropenia (70}.9 feem pua; qib 3 lossis 4,64.2 feem pua), anemia (52.1 feem pua; 37.0 feem pua), thiab thrombocytopenia (40.0 feem pua ; Qib 3 lossis 4,21.2 feem pua ), thiab 76.4 feem pua (qib 3 lossis 4,44.8 feem pua).
Piv nrog rau CAR-T txoj kev kho mob uas sau cov neeg mob hlwb thiab xa rov qab cov tshuaj tom qab kev kho mob, txoj kev tswj hwm ntawm Teclistamab subcutaneous txhaj kuj coj tau yooj yim dua rau kev kho mob. Nws tsim nyog sau cia tias Johnson & Johnson tus nqi Teclistamab ntawm $ 474, 000 ib xyoos, txawm tias siab dua $ 465, 000 ib xyoos, uas yog "sib npaug" ntawm kev nkag mus rau kev kho mob. Los ntawm kev sib piv zoo, tsis muaj qhov sib txawv ntawm Teclistamab thiab Carvykti, thiab peb yuav pom tias cov khoom sib txawv ntawm Johnson & Johnson yog cov khoom sib tw.
Teclistamab nyob rau hauv kev kho mob li cas?
Tsis muaj qhov tsis ntseeg tias Teclistamab tam sim no siv tom qab PI, IMiD thiab anti-CD38 antibody kev kho mob, tab sis raws li kev soj ntsuam saum toj no, cov ntaub ntawv ntawm Teclistamab hauv kev tshawb fawb soj ntsuam tsis muaj txiaj ntsig zoo dua Carvykti, thiab seb CAR-T lossis Teclistamab tom qab kev nce qib tseem nyob. yuav tsum nyiam ntawm cov lus teb los ntawm cov ntaub ntawv tshawb fawb tiag tiag.
Ob leeg Teclistamab thiab CAR-T tuaj yeem ua lub luag haujlwm hauv kev kho rrMM. Ntxiv rau Carvykti, ntau cov tshuaj CAR-T xws li Abecma thiab CT103A tuaj yeem ntes tau tom qab. Txawm hais tias qhov kev ua tau zoo ntawm CAR-T ntawm rrMM, qee cov neeg mob tsim cov tshuaj tiv thaiv sai tom qab kev txhaj tshuaj, nrog rau qhov nruab nrab PFS ntawm 8.8 txog 18.3 lub hlis thiab ib xyoo 1- xyoo kev tso tawm tus nqi ntawm 70 feem pua ntawm cov neeg mob ua tiav sCR lossis CR.Nrog cov txheej txheem kev kho mob sib txawv, Teclistamab tuaj yeem ua si ib qho chaw hauv cov neeg mob uas ua tiav tom qab kev kho CAR-T, uas yog, Teclistamab raws li kev kho mob tom qab ntawm kev kho mob CAR-T.
Bortezomib thiab Daratumumab tau coj qhov zoo tshaj plaws-mover hauv MM kev kho mob, thiab Teclistamab teev tsis muaj qhov tseem ceeb hauv MM dual antibody therapy. Ntxiv rau GPRC5D / CD3 dual antibody tseem nyob rau hauv txoj kev loj hlob, lwm lub tuam txhab tau poob cov hlau lead hauv kev ua lag luam ntawm refractory thiab relapsed MM. Nyob rau hauv lub era ntawm immunotherapy thiab cell therapy, domestic innovative tshuaj yog maj catching, tab sis Suav tuam txhab uas muag tseem nyob rau hauv lawv cov thawj theem nyob rau hauv cov nqe lus ntawm lub tsev patent teeb meem, multi-target thiab multi-mechanism pipeline tis, thiab kev sib koom layout ntawm upstream thiab downstream phiaj xwm chaw. Nyob rau hauv lub neej yav tom ntej, nrog rau kev txhim kho cov nplai ntawm kev lag luam tshuaj, kev sib tsoo ntawm Tuam Tshoj cov chaw muag tshuaj thiab cov lag luam loj txawv teb chaws yog qhov tsis muaj, thiab Johnson & Johnson lub tswv yim layout hauv kev kho MM yog tsim nyog kawm.
