AstraZeneca's BTK Tus Kws Kho Mob Calquence (acalabrutinib) Muaj Lub Plawv Zoo Txog Kev Nyab Xeeb Hauv Kev Kho Tus Mob Hlwb Hlwb Mob Lymphocytic (CLL)!

AstraZeneca nyuam qhuav tshaj tawm rau 62nd Lub Rooj Sab Laj Txhua Xyoo ntawm Asmeskas Lub Koom Haum Saib Xyuas Kev Noj Qab Haus Huv (ASH) tias 762 cov neeg mob laus uas mob lyukhotic leukemia (CLL) leej twg tau txais cov tshuaj tiv thaiv anticancer Calquence (acalabrutinib) tshuaj tua kab mob rau hauv lub cev muaj mob plawv (CV) Kev soj ntsuam cov ntaub ntawv kev nyab xeeb. CLL yog hom khaub thuas tshaj rau neeg laus. Kev soj ntsuam hauv pawg tau koom nrog tag nrho 4 qhov kev sim tshuaj, thiab cov ntaub ntawv pom tau hais tias qhov tshwm sim ntawm cov kev mob tshwm sim tsis zoo (AE) ua rau kev tshem tawm yeeb tshuaj muaj tsawg heev.

Kev tsom xam ua ke no suav nrog cov neeg mob uas tsis tau txais kev kho mob CLL thiab cov neeg mob uas rov huam dua los yog refractory CLL. Cov neeg mob no tau los ntawm ELEVATE TN thiab ASCEND theem 3 kev sim, nrog rau 15-H-0016 theem II kev sim thiab ACE-CL-001 I / Phase II sim. Kev tsom xam pom tias nrog kev soj qab taug qab nruab nrab ntawm 25.9 lub hlis, 129 cov neeg mob (17%) qhia txog qib qis ntawm cov kev mob tshwm sim tsis zoo, thiab tsuas yog 7 tus neeg mob (0.9%) tau txais kev kho mob vim tias qhov mob tsis zoo.

Jennifer Brown, MD, tus thawj coj thiab tus thawj xibfwb tshawb xyuas ntawm CLL Center, Lub Tsev Haujlwm Saib Xyuas Hematological Malignancies, Dana-Farber Cancer Institute, hais tias:" Cov kev phom sij tsis zoo tau dhau los ua kev siv Bruton' s tyrosine kinase (BTK) inhibitors rau kev kho mob ntawm cov mob ntsws lymphocytic kom zoo (CLL). ) Cov kev xav tseem ceeb rau cov neeg mob, kev mob plawv yog ib qho ua rau muaj kev cuam tshuam. Cov ntaub ntawv los ntawm kev tshawb xyuas qhov no qhia pom tias Calquence muaj kev pheej hmoo tsawg dua ntawm cov kev mob tshwm sim, zoo ib yam li cov neeg tsis tau txais kev kho mob CLL, uas muab cov kws kho mob tiv thaiv ntxiv thaum muab tshuaj rau txoj kev kho no."

José Baselga, Tus Lwm Thawj Coj ntawm Oncology Kev Tshawb Fawb thiab Kev Loj Hlob ntawm AstraZeneca, tau hais tias:" Qhov kev tshawb nrhiav tau tag nrho ntawm peb 4 qhov chaw soj ntsuam tau ntxiv dag zog rau kev mob plawv ntawm Calquence hauv kev kho CLL. Los ntawm Calquence, peb lub hom phiaj yog xaiv hom phiaj BTK los pab txhim kho kev nyab xeeb. Thiab lub sijhawm ua raws kev ua haujlwm ntev ntev thaum tswj kev ua tau zoo."

Hauv qhov tshuaj meta-tsom, qhov nruab nrab ntawm cov neeg mob uas tau txais Calquence kho yog 24.9 lub hlis. Cov xwm txheej hauv lub plawv uas tau tshwm sim hauv 2% lossis ntau dua ntawm cov neeg mob suav nrog atrial fibrillation (4%), atrial fibrillation / flutter (5%), palpitations (3%), thiab tachycardia (2%). Qhov tshwm sim ntawm atrial fibrillation zoo ib yam li cov tsis kho mob CLL (6%).

Peb Caug-xya (4%) cov neeg mob tau txais Calquence monotherapy paub txog qib ≥3 mob plawv, uas 25% tau tshaj tawm lawv hauv thawj 6 lub hlis ntawm kev kho mob. Cov xwm txheej mob tsis zoo ntawm qib include3 suav nrog atrial fibrillation (1.3%), ua tiav atrioventricular block (0.3%), mob hlab ntsha tawg (0.1%), atrial flutter (0.1%), ntu ntawm atrioventricular block Hysteresis (0.1%) thiab ventricular fibrillation ( 0.1%). Qeb 5 qhov xwm txheej tshwm sim hauv 2 tus neeg mob (1 kis yog mob plawv tsis txaus, 1 rooj plaub yog mob plawv).

Tshaj tag nrho, 91% ntawm cov neeg mob plawv AEs thiab 79% ntawm cov neeg mob uas tsis muaj mob AEs muaj ib lossis ntau dua cov kev muaj feem ua ntej muaj mob ua ntej Calquence kho. Hauv cov neeg mob uas muaj mob AEs, qhov tshwm sim ntawm cov kab mob plawv feem ntau (ntau dua los yog sib npaug rau 20%) yog kub siab (67%), hyperlipidemia (29%) thiab arrhythmia (22%).

AstraZeneca tseem tshawb txog lwm yam kev sim ntawm CLL, suav nrog ELEVATE-RR theem 3 kev sim (ACE-CL-006), uas yuav ntsuas qhov ua tau zoo ntawm Calquence thiabibrutinibhauv kev kho cov neeg mob CLL uas muaj feem pheej hmoo. Cov ntaub ntawv los ntawm qhov kev kawm no vam tias yuav yog 2021 Tshaj Tawm.

Calquence tau pom zoo los ntawm Asmeskas FDA rau kev ua lag luam nrawm nrawm rau Lub Kaum Hlis 2017. Qhov ntsuas muaj xws li: (1) Rau cov neeg laus cov neeg mob uas rov mob lossis tso ntshav rov qab mob hlwb (MCL) uas yav tas los tau txais tsawg kawg ib txoj kev kho; (2) Siv Rau Kev kho mob rau cov neeg mob laus uas mob lymphocytic leukemia (CLL) lossis cov qe ntshav ntawm tes me me (SLL).

Calquence' s kev ua tshuaj kws muaj tshuaj yogacalabrutinib, uas yog tus xaiv zoo heev, muaj zog thiab covalent Bruton tyrosine kinase (BTK) inhibitor uas tiv thaiv BTK los ntawm kev khi ruaj khov. BTK yog kev tswj hwm qhov tseem ceeb ntawm B cell receptor (BCR) cov paib piav qhia. Nws tau dav dav hauv ntau hom kev hematological malignancies thiab koom nrog txoj kev loj hlob, thauj, chemotaxis thiab kev nplaum ntawm B hlwb. Yog li, nws yog ib qho tseem ceeb rau kev kho mob hematological malignancies. Phiajzeb. Hauv qhov kev tshawb fawb preclinical, acalabrutinib qhia tau tias muaj qhov cuam tshuam tsawg kawg-phiaj yam.

Tam sim no, Calquence raug tsim rau ntau hom B-cell ntshav qog nqaij hlav, nrog rau CLL, MCL, diffuse loj B-cell lymphoma (DLBCL), Waldenstrom macroglobulinemia (WM), follicular lymphoma (FL), Ntau yam myeloma thiab lwm yam mob hematological malignancies.

Calquence' s mechanism ntawm kev ua yog tib yam li AbbVie / J& J' s blockbuster ntshav mob ntshav tshuaj Imbruvica (ibrutinib), uas yog thawj BTK inhibitor pom zoo thoob ntiaj teb. Txij li thaum nws pom zoo thawj zaug thaum Lub Kaum Ib Hlis 2013, Imbruvica tau pom zoo rau ntau npaum li ntawm 11 kev kho mob hauv 6 thaj chaw muaj kabmob, thiab kev muag khoom thoob ntiaj teb tau nce siab zuj zus. Thaum xaus lub Rau Hli xyoo no, lub koom haum kws tshawb fawb txog kev lag luam kev lag luam EvaluatePharma tso tawm cov lus kwv yees hais tias nrog cov kev lag luam txuas ntxiv mus thiab qhov taw qhia nce ntxiv, Imbruvica' s muag hauv 2026 yuav txog 10.722 billion US dollars, dhau los ua' s thib tsib zoo tshaj plaws muag tshuaj.