Inhibitor Parsaclisib: Tag Nrho Tus Nqi Them Nqi Theem 2 Txoj Kev Kawm hauv Suav Teb ncav cuag 91.7 feem pua ​​!

Cinda Bio's partner Incyte recently announced data from three ongoing Phase 2 studies of parsaclisib (IBI-376) at the 63rd American Society of Hematology Annual Meeting and Expo (ASH 2021). Parsaclisib is a new, potent, highly selective, new-generation phosphatidylinositol 3-kinase δ (PI3Kδ) oral inhibitor.

3 cov kev tshawb fawb no tau soj ntsuam parsaclisib rau kev kho mob ntawm relapsed los yog refractory follicular lymphoma (FL, CITADEL-203 txoj kev tshawb NCT03126019), marginal zone lymphoma (MZL, CITADEL-204 kawm NCT03144674), mantle cells4026019 (MZL) . Hauv txhua txoj kev tshawb fawb, cov neeg mob tsim nyog tau txais parsaclisib 20 mg ib hnub ib zaug rau 8 lub lis piam, tom qab ntawd 20 mg ib zaug hauv ib lub lis piam (cov koob tshuaj txhua lub limtiam WG) lossis 2.5 mg ib hnub ib zaug (txhua hnub pab pawg DG). Ntawm lawv, kev noj tshuaj txhua hnub yog thawj qhov kev xaiv, thiab cov neeg mob WG raug tso cai hloov mus rau DG. Hauv txhua txoj kev tshawb fawb, kev kho mob tiv thaiv yog xav tau rau Pneumocystis jiroveci pneumonia (PJP).

Thawj qhov kawg ntawm CITADEL-203, -204, thiab -205 kev tshawb fawb yog lub hom phiaj teb tus nqi (ORR). Cov ntsiab lus tseem ceeb thib ob suav nrog kev ua tiav cov lus teb (CRR), lub sijhawm teb (DOR), kev muaj sia nyob tsis muaj sia nyob (PFS), kev muaj sia nyob tag nrho (OS), kev nyab xeeb thiab kev zam. Tag nrho cov ntsiab lus ntawm radiology-raws li qhov kawg yog raws li kev soj ntsuam ntawm pawg neeg saib xyuas ywj pheej (IRC) kev soj ntsuam.

Raws li cov kev tshawb fawb yav dhau los ntawm ASH 2020 lub rooj sib tham, cov ntaub ntawv kho tshiab ntawm cov kev ntsuam xyuas tseem ceeb ntawm lub rooj sib tham no txuas ntxiv qhia tias kev kho parsaclisib ua rau sai thiab ntev- kav ntev teb thiab tau txais kev nyab xeeb. Tshwj xeeb: (1) Hauv 3 qhov kev tshawb fawb, ORR ntawm pawg DG yog 77.7 feem pua, 58.3 feem pua, thiab 70.1 feem pua, CRR yog 19.4 feem pua, 4.2 feem pua, thiab 15.6 feem pua, thiab qhov nruab nrab DOR yog 14.7 lub hlis thiab 12.2 feem. hli thiab 12.1 hli; qhov nruab nrab PFS yog 15.8 lub hlis, 16.5 lub hlis, thiab 13.6 lub hlis, raws li, thiab qhov nruab nrab OS tsis ncav cuag. (2) Hauv 3 qhov kev tshawb fawb, ORR ntawm txhua pawg neeg mob yog 75.4 feem pua, 58.0 feem pua, 68.5 feem pua, CRR yog 18.3 feem pua, 6.0 feem pua, thiab 17.6 feem pua, thiab qhov nruab nrab DOR yog 14.7 hli, 12.2 hli, thiab 13.7. , raws. Lub hli; qhov nruab nrab PFS yog 14.0 hli, 16.5 hli, 11.99 hli, thiab qhov nruab nrab OS tsis ncav cuag.

Cov txiaj ntsig tseem ceeb ntawm 3 CITADEL kev tshawb fawb

Cov ntaub ntawv no txhawb nqa thiab ntxiv rau daim ntawv thov tshuaj tshiab (NDA) rau parsaclisib tau txais los ntawm US FDA thaum lub Kaum Ib Hlis 2021: rau kev kho mob ntawm 3 hom relapsed lossis refractory non-Hodgkin's lymphoma (NHL). Ntawm lawv, NDA rau kev kho mob ntawm relapsed los yog refractory MZL thiab MCL yuav raug tshuaj xyuas ua ntej, thiab NDA rau kev kho mob ntawm relapsed los yog refractory FL yuav raug tshuaj xyuas rau tus qauv.

Tsis yog-Hodgkin's Lymphoma (NHL) yog tsim los ntawm ntau hom subtypes thiab yog ib qho ntawm cov qog nqaij hlav ntau tshaj plaws. Txij li cov kev kho mob tam sim no tsis tuaj yeem kho ntau tus neeg mob, kev xaiv kho tshiab yuav tsum tau ua.

Parsaclisib tau tsim sai thiab ntev - kev tso tawm mus ntev rau cov neeg mob uas muaj ntau yam NHL subtypes, thiab muaj kev nyab xeeb tswj tau. Cov tshuaj muaj peev xwm muab kev kho mob tshiab muaj txiaj ntsig rau cov neeg mob rov qab los lossis refractory FL, MZL, thiab MCL. .

parsaclisib (IBI-376) is a potent, highly selective, new-generation phosphatidylinositol 3-kinase delta (PI3K delta) oral inhibitor, currently being evaluated as a monotherapy for non-Hodgé in multiple phase 2 clinical trials The therapeutic effect of gold lymphoma (FL, MZL, MCL) and autoimmune hemolytic anemia. In addition, Incyte is also conducting a registered clinical trial of parsaclisib and ruxolitinib in the treatment of patients with myelofibrosis. Incyte also plans to conduct a trial to evaluate parsaclisib combined with tafasitamab in the treatment of diffuse B-cell lymphoma.

Parsaclisib tshuaj qauv

In December 2018, Innovent and Incyte reached a strategic cooperation on three drug candidates in clinical trials, including parsaclisib (PI3Kδ inhibitor). According to the terms of the agreement, Cinda Bio has the rights to develop and commercialize parsaclisib and two other drug candidates in Mainland China, Hong Kong, Macau and Taiwan.

Ntawm ASH 2021 lub rooj sib tham txhua xyoo, Innovent tshaj tawm cov ntaub ntawv ntawm Tuam Tshoj pivotal Phase 2 kev tshawb fawb soj ntsuam (CIBI376A201) ntawm parsaclisib hauv kev kho mob ntawm cov neeg mob rov qab los yog refractory follicular lymphoma (r / r FL). Cov neeg mob tsim nyog tau txais parsaclisib ntawm koob tshuaj 20 mg ib hnub ib zaug rau thawj 8 lub lis piam ntawm kev nkag mus rau txoj kev tshawb no, ua raws li kev kho mob ntawm 2.5 mg ib hnub ib zaug. Tam sim no, tag nrho ntawm 36 qhov kev kawm tau raug tso npe, ntawm 24 qhov xwm txheej tuaj yeem ntsuas qhov ua tau zoo.

Cov ntaub ntawv qhia tias parsaclisib qhia tau hais tias muaj kev nyab xeeb thiab ua tau zoo. Txoj kev tshawb no qhia tau hais tias ORR ntawm parsaclisib ib leeg nyob rau hauv r/r FL cov neeg mob (N=24) mus txog 91.7 feem pua ​​(95 feem pua ​​CI: 73 feem pua, 99 feem pua), uas tag nrho cov teb (CR) mus txog 16.7 feem pua. , thiab cov lus teb ib nrab (PR) nce mus txog 75 feem pua. Parsaclisib muaj tus nqi tso tawm siab, feem ntau ua tau zoo, thiab nws txoj kev nyab xeeb yog tswj tau.