Yaqinda ASCO-GI konferentsiyasida e'lon qilingan ONO-4538-12 klinik tadqiqoti shuni ko'rsatdiki, platsebo bilan solishtirganda Nivolumab bemorlarning o'lim xavfini 37 foizga kamaytirdi va Nivolumab bilan davolangan bemorlarning umumiy 12 oylik omon qolish darajasi 26.6 foizga etdi. . Platsebo qabul qilingan bemorlarning 12 oylik umumiy omon qolish darajasi atigi 10.9% ni tashkil etdi.
19 yil 2017 yanvarda Bristol-Myers Squibb ONO-4538-12 deb nomlangan klinik tadqiqot natijalarini e'lon qildi, bu Nivolumab me'da saratoni bilan og'rigan bemorlarda o'lim xavfini sezilarli darajada kamaytirganini ko'rsatdi. (HR37; p <0.63) va hozirda bunday bemorlar uchun standart davolash mavjud emas. ONO-0.0001-4538 tadqiqoti bunday bemorlarda Nivolumabning samaradorligi va xavfsizligini baholaydigan, randomizatsiyalangan, ikki marta ko'r, platsebo-nazorat qilinadigan III fazali klinik tadqiqotdir. Tadqiqotning asosiy yakuniy nuqtasi umumiy omon qolish (OS) edi. Nivolumab guruhi va platsebo guruhidagi o'rtacha operatsion tizim 12 oy (5.32% CI: 95-4.63) va 6.41 oy (4.14% CI: 95-3.42) (p <4.86). Nivolumab guruhi va platsebo guruhining 0.0001 oylik umumiy omon qolish darajasi mos ravishda 12% (26.6% CI: 95-21.1) va 32.4% (10.9% CI: 95-6.2) ni tashkil etdi. Bemor Nivolumab bilan davolangandan so'ng, ikkilamchi so'nggi nuqta ob'ektiv javob darajasi 17.0% ga (11.2% CI: 95-7.7) va javobning o'rtacha davomiyligi 15.6 oyni tashkil etdi (9.53% CI: 95-6.14). Platsebo guruhida ob'ektiv javob darajasi 9.82% ni tashkil etdi (0% CI: 95-0.0).
Nivolumab’s safety is consistent with previous reports of solid shish studies. In the Nivolumab group and placebo group, the incidence of all treatment-related adverse events (TRAE) was 42.7% and 26.7%, and the incidence of grade 3/4 TRAE was 10.3% and 4.3%, respectively. Grade 3/4 TRAEs occurred in more than 2% of patients in the Nivolumab group including diarrhea, fatigue, decreased appetite, fever, and increased AST and ALT. Grade 3/4 TRAEs occurred in more than 2% of patients in the placebo group were fatigue and decreased appetite . In the Nivolumab group and the placebo group, the incidence of discontinuation TRAE was similar, 2.7% and 2.5%, respectively.
ONO-4538-12 tadqiqot ma'lumotlari, San-Frantsisko, Kaliforniya, AQSh, 2017 yil 2-yanvar kuni soat 00:3 dan 30:19 gacha (Gastrointestinal Onkology Simpozium (ASCOGI)) ning ochilgan og'zaki hisobotida e'lon qilindi (2-referat).
The ONO-4538-12 study is the first phase III randomized clinical trial of tumor immunoterapiya that improves the survival rate of patients with advanced or relapsed gastric cancer . We think the results of Nivolumab treatment are encouraging because gastric cancer is the cause of cancer deaths worldwide At the forefront of this, there is a huge unmet need in patients with advanced gastric cancer who are intolerant to chemotherapy or who have failed chemotherapy, “said Ian M. Waxman, MD, head of research and development at Bristol-Myers Squibb Gastrointestinal Cancer.
"Ushbu natijalar Nivolumabning rivojlangan yoki qaytalanadigan oshqozon saratonini davolashdagi klinik foydasini tasdiqlaydi va oshqozon saratonini davolash bo'yicha Nivolumabni keyingi tadqiqotlari uchun kuchli asos yaratadi", - klinik bosh tergovchi, Seul Osiyo Tibbiy Markazi, Ulsan universiteti, Janubiy Onkologiya tibbiyot kollejining tibbiyot fanlari doktori va tibbiyot fanlari doktori Koron Yon-KooKang fikr bildirdi.
ONO-4538-12 tadqiqotlari haqida
ONO-4538-12 tadqiqoti (NCT02267343) Yaponiya, Janubiy Koreya va Tayvanda o'tkazilgan III bosqich, randomizatsiyalangan, ikki marta ko'r, platsebo-nazorat ostidagi klinik tadqiqotdir. Nivolumab terapevtik davolash samaradorligi va xavfsizligi bilan og'rigan yoki qaytalanuvchi oshqozon saratoni (shu jumladan, oshqozon-qizilo'ngach birikmasi saratoni) bilan og'rigan bemorlarni davolashda rezektsiya qilish mumkin emasligi (jarrohlik yo'li bilan olib tashlanishi mumkin emas) va standarti samarasizligi yoki toqat qilmasligi baholandi. Klinik tadqiqot Yaponiyaning Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb Nivolumab R&D hamkori tomonidan o'tkazildi.
ONO-4538-12 tadqiqotida bemorlarga nivolumab 3 mg / kg yoki platsebo har ikki haftada bir marta o'simtani toqat qilolmaydigan toksikligi sababli o'sguncha yoki to'xtaguniga qadar qabul qilindi. Birlamchi so'nggi nuqta OS platseboga nisbatan samaradorligi uchun baholandi. Ikkilamchi so'nggi nuqtalarga ob'ektiv javob darajasi, javobning davomiyligi, progressiyasiz omon qolish, maqbul umumiy javob darajasi, o'simta reaktsiyasiga vaqt, kasallikning nazorat darajasi va xavfsizlik bilan bog'liq o'zgaruvchilar kiradi.
AQSh oziq-ovqat va farmatsevtika idorasi (FDA) tomonidan tasdiqlangan NIVOLUMAB ko'rsatkichi
Nivolumab monotherapy can be used to treat BRAFV600 mutation-positive unresectable or metastatic melanoma . Based on the significant effect of Nivolumab on progression-free survival, the indication was quickly approved. According to the clinical benefit results of the confirmatory test, the continued approval of the indication can be judged.
BRIVV600 yovvoyi turini tuzatib bo'lmaydigan yoki metastatik melanomani davolash uchun Nivolumab monoterapiyasidan foydalanish mumkin.
Nivolumab Ipilimumab bilan biriktirilgan yoki metastatik melanomali bemorlarni davolash uchun javob beradi. Progressiyasiz hayot kechirishga terapiyaning ajoyib ta'siriga asoslanib, ko'rsatma tezda tasdiqlandi. Ko'rsatmani doimiy ravishda tasdiqlash tasdiqlovchi testning klinik foydalari asosida baholanadi.
Nivolumab can be used to treat metastatic kichik hujayrali o'pka saratoni (NSCLC) that progresses during or after platinum-based chemotherapy regimens. For patients with EGFR mutations or ALK rearrangements, before using Nivolumab, it should be confirmed that the patients have used FDA-approved therapeutic drugs for these genetic abnormalities and disease progression has occurred.
Nivolumab antiangiogenik dorilarni qo'llagan rivojlangan buyrak hujayrali karsinomasi (RCC) bo'lgan bemorlarni davolash uchun ishlatilishi mumkin.
Nivolumab can be used for autologous hematopoietic stem cell transplantation (HSCT) and after transplantation, brentuximabvedotin is used to treat recurrent or progressive classic Xodkin limfomasi (cHL). Based on the drug’s significant effect on the overall response rate, the indication was approved quickly. The continued approval of the indication will be judged based on the clinical benefit results of the confirmatory test.
