AstraZeneca BTK inhibitor Calquence monotherapy thawj-kab kev kho mob 4-xyoo tag nrho cov lus teb tau (ORR) txog 97%!

AstraZeneca tau tshaj tawm tam sim no ntawm 25 lub rooj sib tham ib xyoos ib zaug ntawm European Hematology Association (EHA) thawj-kab ib leeg-tus neeg sawv cev tsom tshuaj anticancer tshuaj Calquence (acalabrutinib) rau mob lymphocytic leukemia (CLL) cov neeg mob nyob rau theem II ib leeg-caj npab ACE- Cov ncauj lus kom ntxaws kuaj CL-001, nrog rau cov ntaub ntawv ntev thiab tau txais txiaj ntsig ntawm Calquence' s Theem III ASCEND kev sim hauv cov neeg mob uas rov ua dua lossis rov ua dua CLL. Cov txiaj ntsig tau pom tias 4-xyoo tag nrho cov kev kho kom rov qab (ORR) ntawm Calquence ib tus neeg sawv cev rau kev kho mob thawj zaug ntawm cov neeg mob tshiab tau kho CLL tau txog 97%, thiab 18-lub hlis muaj sia nyob ntawm cov neeg mob uas rov mob / rov ua haujlwm CLL yog kom ntau npaum li 88%, thiab tau qhia txog kev nyab xeeb lub sijhawm ntev.

Kev sim ACE-CO-001 tau sim nyob rau hauv cov neeg mob tsis muaj mob yav dhau los CLL thiab tshawb xyuas qhov ua tau zoo thiab kev nyab xeeb ntawm Calquence (100 mg ob zaug ib hnub [n=62], lossis 200 mg ib hnub ib zaug [n=37]). Thaum lub Tsib Hlis 1, 2015, cov neeg mob uas tau txais 200 mg koob tshuaj kom hloov pauv mus rau 100 mg koob tshuaj dua.

Cov ntaub ntawv qhia tau hais tias nrog kev soj qab taug qab ntau dua 4 xyoos (4.4 xyoo), 86% ntawm cov neeg mob CLL tseem tau txais Calquence raws li kev kho kab mob kev nkeeg thawj zaug. Cov ntaub ntawv qhia tias tag nrho cov lus teb tau teb (ORR) yog 97% (tus nqi teb tag nrho [CR]=7%, tus lej feem teb [PR]=90%), thiab ORR yog 100% hauv pawg neeg mob ntawm cov neeg mob siab cov yam ntxwv mob txaus ntshai, suav nrog Genome aberrations (17p deletion [n=9] thiab TP53 hloov pauv [n=9]), kev hloov tshuaj tiv thaiv kab mob (tsis haum IGHV [n=57]), karyotype nyuaj (n=12). Txhua tus neeg mob (n=97) tau txo qis cov qog ntshav. Cov txiaj ntsig kev nyab xeeb qhia tsis muaj teeb meem tshiab ntev.

Qhov kev tshawb ASCEND yog lub ntiaj teb, xaiv, ntau, ntau hom, qhib-daim ntawv lo theem III sim nyob rau hauv cov neeg mob uas rov mob lossis rov ua dua (R / R) CLL. Nws tshawb xyuas Calquence (100 mg ob zaug ib hnub) thiab cov kws tshawb nrhiav 'kev xaiv Kev ua tau zoo thiab kev nyab xeeb ntawm rituximab ua ke nrog idelalisib (IdR) regimen lossis rituximab ua ke nrog bendamustine (BR) kev tswj hwm.

Kev ntsuam xyuas zaum kawg ntawm txoj kev tshawb no pom tias thaum 18 lub hlis ntawm kev kho mob, pab pawg kho mob Calquence kwv yees tias 82% ntawm cov neeg mob CLL tseem muaj sia nyob thiab tsis muaj mob ntxiv, thiab kev faib ua feem ntawm cov neeg mob kho rituximab nrog idelalisib lossis khoovamustine kwv yees thaum 48%. Cov ncauj lus kom ntxaws tau muaj raws li nram no:

Richard R. Furman, tus thawj coj ntawm CLL Kev Tshawb Fawb Chaw ntawm Weill Cornell Medical College, tau hais tias:" Cov ntaub ntawv no qhia tias Calquence tsis muaj teeb meem kev nyab xeeb tshiab thiab paub tseeb tias cov tshuaj muaj peev xwm kho kev nyab xeeb rau kev kho mob thaum xub thawj (kho mob thawj zaug) , rov tshwm sim lossis rov ua haujlwm rau tus neeg mob CLL muab cov txiaj ntsig kev kho mob ntev ntev. Calquence yuav muab cov kev kho mob tseem ceeb thiab tsim nyog rau cov neeg mob CLL."

José Baselga, tus lwm thawj coj ntawm AstraZeneca's oncology kev tshawb fawb thiab kev tsim kho, tau hais tias: "Cov ntaub ntawv ntev no rov qab hais tias Calquence yuav muab cov neeg mob CLL nrog cov lus teb ntev nrog kev nyab xeeb zoo. Cov neeg mob CLL feem ntau muaj 70 xyoo lossis laus dua, thiab feem ntau Kev kho mob ncua ntev, uas ua rau muaj kev nyab xeeb txuas ntxiv mus thiab muaj txiaj ntsig zoo cuam tshuam rau lawv lub neej zoo."

Cov txiaj ntsig ntawm theem II ACE-CL-001 kev sim siab muab lub hauv paus rau tus tseem ceeb theem III ELEVATE TN kev sim, uas, ua ke nrog cov txiaj ntsig ntawm theem III ASCEND kev sim, tso US FDA pom zoo rau Calquence los kho CLL lossis lymphocytic me me lymphoma (SLL) Cov hauv paus.

Calquence: BTK inhibitor nrog kev muag txhua xyoo yuav tsum ntau tshaj $ 5 billion

Calquence' s cov tshuaj ua haujlwm zoo yog acalabrutinib, uas yog tus xaiv zoo, muaj zog, thiab covalent Bruton tyrosine kinase (BTK) inhibitor uas ua haujlwm los ntawm kev tsis pub BTK mus tas li. BTK yog kev tswj hwm qhov tseem ceeb ntawm B cell receptor (BCR) cov paib piav qhia. Nws tau dav dav hauv ntau hom hematological malignancies thiab koom nrog txoj kev loj hlob, tsheb thauj mus los, chemotaxis, thiab kev nplaum ntawm B hlwb. Yog li, nws yog ib txoj kev kho mob tseem ceeb rau hematological malignancies Target. Hauv qhov kev tshawb fawb preclinical, acalabrutinib qhia pom tias qhov cuam tshuam tsawg kawg ntawm cov hom phiaj.

Kev ua kom tsis tau raug tsocai tau txais kev pom zoo sai sai los ntawm US FDA thaum Lub Kaum Hli 2017. Qhov ntsuas tam sim no suav nrog: (1) Rau cov neeg mob laus uas rov mob lossis tso zis tso ntshav mastle lymphoma (MCL) uas yav tas los tau txais tsawg kawg ib txoj kev kho; (2) Kev kho mob rau cov neeg mob laus nrog CLL / SLL. Tam sim no, Calquence raug tsim rau ntau yam mob B-cell ntshav qog ntshav, nrog rau CLL, MCL, diffuse loj B-cell lymphoma, Waldenstrom macroglobulinemia (WM), follicular lymphoma (FL), ntau yam mob pob txha mob qog nqaij hlav thiab lwm yam mob hematological malignancies. AstraZeneca muaj kev cia siab ua lag luam siab heev rau Calquence, thiab nws cia siab tias qhov siab tshaj plaws ntawm kev muag tshuaj yuav ncav cuag 5 billion Asmeskas las!

Tus txheej txheem ntawm kev ua ntawm Calquence yog tib yam li Abbrevica (ibrutinib, 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, txij li tam sim no, Imbruvica tau pom zoo txog 10 qhov kev kho mob hauv 6 thaj chaw muaj tus kab mob, thiab kev muag khoom thoob ntiaj teb tau nce linearly. Lub chaw muag tshuaj tshawb xyuas kev lag luam EvaluatePharma yav dhau los tshaj tawm ib daim ntawv tshaj tawm kwv yees tias xyoo 2024, Imbruvica' s muag thoob ntiaj teb yuav nce mus txog 9,5 billion Asmeskas las, dhau los ua lub ntiaj teb' s thib tsib-zoo muag tshuaj.