Ichangobva kuitika yeONO-4538-12 yekiriniki yekuongorora yakabudiswa pamusangano weASCO-GI yakaratidza kuti kana ichienzaniswa ne placebo, Nivolumab yakaderedza ngozi yekufa kwevarwere ne37%, uye huwandu hwehupenyu hwemwedzi gumi nemaviri hwevarwere vanobatwa neNivolumab hwakasvika 12%. . Mwedzi we26.6 wehuwandu hwekupona kwevarwere vanopihwa placebo yaive 12% chete.
Musi waNdira 19, 2017, Bristol-Myers Squibb akazivisa mhedzisiro yeongororo yekiriniki inonzi ONO-4538-12, iyo yakaratidza kuti Nivolumab yakaderedza zvakanyanya njodzi yekufa kune varwere vane kenza yepamusoro yemudumbu vaive vasingakwanisi kana kusashivirira kurapwa kwakajairwa 37% (HR0.63; p <0.0001), uye parizvino hapana kurapa kwakajairwa kuvarwere vakadaro. ONO-4538-12 chidzidzo chikamu chechitatu chisinganzwisisiki, kaviri-bofu, placebo-inodzorwa nekliniki yekuongorora kuongorora kushanda uye kuchengeteka kweNivolumab muvarwere vakadaro. Mhedziso yekutanga yechidzidzo yaive kupona kwese (OS). Iyo yepakati OS muboka reNivolumab uye boka re placebo raiva mwedzi 5.32 (95% CI: 4.63-6.41) uye 4.14 mwedzi (95% CI: 3.42-4.86) (p <0.0001). Mwedzi we12 wehuwandu hwekupona kweboka reNivolumab uye boka re placebo raiva 26.6% (95% CI: 21.1-32.4) uye 10.9% (95% CI: 6.2-17.0), maererano. Mushure mokunge murwere abatwa neNivolumab, chikamu chechipiri chekupedzisira chinangwa chekupindura chakasvika 11.2% (95% CI: 7.7-15.6), uye nguva yepakati yekupindura yaiva mwedzi 9.53 (95% CI: 6.14-9.82). Chiyero chekupindura chinangwa muboka re placebo chaive 0% (95% CI: 0.0-2.8).
Nivolumab’s safety is consistent with previous reports of solid tumarara 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 data rekutsvagisa rakaziviswa mukubudirira kwemuromo mushumo we2017 Gastrointestinal Oncology Symposium (ASCOGI) muSan Francisco, California, USA, kubva 2:00 kusvika 3:30 pm muna Ndira 19 (Abstract No. 2).
The ONO-4538-12 study is the first phase III randomized clinical trial of tumor immunotherapy 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.
"Iyi mhedzisiro inosimbisa kubatsirwa kwekiriniki yeNivolumab pakurapa gomarara repamberi kana rinowanzoitika regastric, uye inopa hwaro hwakasimba hwekuenderera mberi kwekutsvagisa kweNivolumab yekurapa gomarara repamuviri," mupurisa mukuru wekiriniki, Seoul Asia Medical Center, Ulsan University, South. Korea Yoon-KooKang, MD uye MD weMedical College yeOncology, akataura.
Nezve ONO-4538-12 research
ONO-4538-12 yekudzidza (NCT02267343) chikamu chechitatu, randomized, double-blind, placebo-controlled controlled clinical study yakaitwa muJapan, South Korea, neTaiwan. Yakaongorora kusagadziriswa (haigone kubviswa nekuvhiyiwa) uye chiyero cheNivolumab Kurapa kwekurapa hakubatsiri kana kusashivirira mukurapa kwevarwere vane kenza yepamusoro kana inowanzoitika (kusanganisira gastroesophageal junction cancer) kune varwere vane simba uye kuchengeteka. Chidzidzo chekiriniki chakaitwa neJapan's Ono Pharmaceutical Co., Ltd., Bristol-Myers Squibb Nivolumab R & D shamwari.
Muchidzidzo cheOOO-4538-12, varwere vakagamuchira nivolumab 3 mg / kg kana placebo kamwe chete mumasvondo maviri kusvikira bundu richifambira mberi kana kumiswa nekuda kwekusagadzikana kwehuturu. Iyo yekutanga yekupedzisira OS yakaongororwa kuti ibudirire zvine chekuita ne placebo. Sekondari magumo aisanganisira chinangwa chekupindura chiyero, nguva yekupindura, kufambira mberi-kwemahara kupona, yakaringana yakazara mhinduro chiyero, nguva yekumhanyisa kupindura, chirwere chekudzivirira mwero, uye akasiyana-siyana ane chekuchengetedza.
NIVOLUMAB chiratidzo chinotenderwa neUS Chikafu neDrug Administration (FDA)
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.
Nivolumab monotherapy inogona kushandiswa kurapa BRAFV600 yemusango-mhando isingadzoreke kana metastatic melanoma.
Nivolumab inosanganiswa neIpilimumab yakakodzera kurapwa kwevarwere vane unresectable kana metastatic melanoma. Zvichienderana nemhedzisiro inoshamisa yekurapa pane kufambira mberi-kwemahara kupona, chiratidzo chakakurumidza kubvumidzwa. Kuenderera mberi kwekubvumidzwa kwechiratidzo kuchazotongwa zvichibva pamakiriniki ebhenefiti mhedzisiro yeiyo yekusimbisa bvunzo.
Nivolumab can be used to treat metastatic isina-diki kenza yemapapu kenza (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 inogona kushandiswa kurapa varwere vane advanced renal cell carcinoma (RCC) vakashandisa anti-angiogenic zvinodhaka.
Nivolumab can be used for autologous hematopoietic stem cell transplantation (HSCT) and after transplantation, brentuximabvedotin is used to treat recurrent or progressive classic Hodgkin's lymphoma (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.
