Inhibitor Parsaklisib: Xitoyda 2-bosqich tadqiqotining umumiy remissiya darajasi 91,7 foizga yetdi!

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.

Ushbu 3 ta tadqiqot parsaklisibni relapslangan yoki refrakter follikulyar limfoma (FL, CITADEL-203 tadqiqoti NCT03126019), marginal zona limfoma (MZL, CITADEL-204 tadqiqoti NCT03144674), mantiya hujayralarini (N3144674) davolash uchun baholaydi. . Har bir tadqiqotda munosib bemorlarga parsaklisibni 8 hafta davomida kuniga bir marta 20 mg, so'ngra haftada bir marta 20 mg (haftalik dozalash guruhi WG) yoki kuniga bir marta 2,5 mg (kunlik dozalash guruhi DG) olish tayinlangan. Ular orasida kunlik dozalash birinchi tanlovdir va WG bemorlariga DG ga o'tishga ruxsat beriladi. Har bir tadqiqotda Pneumocystis jiroveci pnevmoniyasi (PJP) uchun profilaktik davolash kerak.

CITADEL-203, -204 va -205 tadqiqotlarining asosiy yakuniy nuqtasi ob'ektiv javob darajasidir (ORR). Asosiy ikkilamchi so'nggi nuqtalarga to'liq javob tezligi (CRR), javob davomiyligi (DOR), progressiv omon qolish (PFS), umumiy omon qolish (OS), xavfsizlik va bardoshlik kiradi. Radiologiyaga asoslangan barcha so'nggi nuqtalar mustaqil tekshirish qo'mitasi (IRC) baholashiga asoslanadi.

ASH 2020 yig'ilishidagi oldingi tadqiqot natijalariga asoslanib, ushbu yig'ilishdagi ushbu asosiy tahlillarning yangilangan ma'lumotlari parsaklisib bilan davolash tez va uzoq{1}}davom etishini ko'rsatmoqda. javob beradi va qabul qilinadigan xavfsizlikka ega. Xususan: (1) 3 ta tadqiqotda DG guruhining ORR darajasi 77,7 foiz, 58,3 foiz va 7{49}},1 foiz, CRR 19,4 foiz, 4,2 foiz va 15,6 foiz va o‘rtacha DOR mos ravishda 14,7 oy va 12,2 edi. Oylar va 12,1 oylar; o'rtacha PFS mos ravishda 15,8 oy, 16,5 oy va 13,6 oyni tashkil etdi va o'rtacha OS ga erishilmadi. (2) 3 ta tadqiqotda barcha bemorlar guruhlari uchun ORR 75,4 foiz, 58,0 foiz, 68,5 foiz, CRR 18,3 foiz, 6,0 foiz va 17,6 foizni tashkil etdi va o'rtacha DOR 14,7 oy, 12,2 oy va 137 foizni tashkil etdi. , mos ravishda. Oylar; o'rtacha PFS 14,0 oy, 16,5 oy, 11,99 oy edi va o'rtacha OS ga erishilmadi.

3 ta CITADEL tadqiqotining asosiy natijalari

These data support and supplement the new drug application (NDA) for parsaclisib accepted by the US FDA in November 2021: for the treatment of 3 types of relapsed or refractory non-Hodgkin's lymphoma (NHL). Among them, the NDA for the treatment of relapsed or refractory MZL and MCL will be reviewed first, and the NDA for the treatment of relapsed or refractory FL will be reviewed for the standard.

Non-Hodgkin's Lymphoma (NHL) is composed of different subtypes and is one of the most common cancers. Since current treatment options cannot cure a considerable number of patients, new treatment options are needed.

Parsaklisib turli xil NHL subtiplari bo'lgan bemorlarda tez va uzoq{0}}remissiyani keltirib chiqardi va nazorat qilinadigan xavfsizlikka ega. Preparat relapsli yoki refrakter FL, MZL va MCL bilan og'rigan bemorlar uchun mazmunli yangi davolashni ta'minlash potentsialiga ega. .

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.

Parsaklisib kimyoviy tuzilishi

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.

ASH 2021 yillik yig'ilishida Innovent relapsli yoki refrakter follikulyar limfoma (r/r FL) bilan og'rigan bemorlarni davolashda parsaklisibning Xitoyning asosiy 2-bosqich klinik tadqiqoti (CIBI376A201) ma'lumotlarini e'lon qildi. Muvofiq bemorlar tadqiqotga kirishning dastlabki 8 haftasida kuniga bir marta 20 mg dozada parsaklisibni, so'ngra kuniga bir marta 2,5 mg davolash rejimini oldilar. Hozirgi vaqtda jami 36 ta sub'ekt ro'yxatga olingan, ulardan 24 tasi samaradorlik uchun baholanishi mumkin.

Ma'lumotlar shuni ko'rsatadiki, parsaklisib yaxshi xavfsizlik va samaradorlikni ko'rsatadi. Tadqiqot shuni ko'rsatdiki, r/r FL bemorlarida parsaklisibning ORR (N=24) 91,7 foizga (95 foiz CI: 73 foiz, 99 foiz), shundan to'liq javob darajasi (CR) 16,7 foizga yetdi. , va qisman javob darajasi (PR) 75 foizga etadi. Parsaklisib yuqori remissiya darajasiga ega, odatda yaxshi muhosaba qilinadi va uning xavfsizligi nazorat qilinadi.