Daraasaddii ugu dambeysay ee ONO-4538-12 ee lagu sii daayay shirkii ASCO-GI waxay muujisay in marka la barbar dhigo placebo, Nivolumab ay hoos u dhigtay khatarta dhimashada bukaannada 37%, iyo guud ahaan 12-bilood heerka badbaadada bukaannada lagu daweeyay Nivolumab ayaa gaadhay 26.6% . Qiyaasta guud ee badbaadada 12-bilood ee bukaannada la maamulo placebo waxay ahayd kaliya 10.9%.
Janaayo 19, 2017, Bristol-Myers Squibb ayaa ku dhawaaqday natiijada cilmi-baaris caafimaad oo loo yaqaan ONO-4538-12, taas oo muujisay in Nivolumab ay si weyn u yaraysay khatarta dhimashada bukaannada qaba kansarka caloosha oo sarreeya kuwaas oo aan waxtar lahayn ama u dulqaadan karin daaweynta caadiga ah 37% (HR0.63; p <0.0001), oo hadda ma jirto daaweyn caadi ah oo loogu talagalay bukaannada noocaas ah. Daraasadda ONO-4538-12 waa wejiga III randomized, laba-indho la'aan, daraasad bukaan-socod-koontarool ah oo lagu qiimeeyo waxtarka iyo badbaadada Nivolumab ee bukaannada noocaas ah. Dhammaadka aasaasiga ah ee daraasaddu waxay ahayd badbaadada guud (OS). Dhexdhexaadinta OS ee kooxda Nivolumab iyo kooxda placebo waxay ahaayeen 5.32 bilood (95% CI: 4.63-6.41) iyo 4.14 bilood (95% CI: 3.42-4.86) (p <0.0001). Heerarka badbaadada guud ee 12-bilood ee kooxda Nivolumab iyo kooxda placebo waxay ahaayeen 26.6% (95% CI: 21.1-32.4) iyo 10.9% (95% CI: 6.2-17.0), siday u kala horreeyaan. Ka dib markii bukaanka lagu daaweeyay Nivolumab, heerka jawaabta ujeedka ugu dambeeya ee heerka labaad ayaa gaadhay 11.2% (95% CI: 7.7-15.6), iyo muddada dhexe ee jawaabta waxay ahayd bilaha 9.53 (95% CI: 6.14-9.82). Heerka jawaabta ujeedada ee kooxda placebo waxay ahayd 0% (95% CI: 0.0-2.8).
Nivolumab’s safety is consistent with previous reports of solid buro 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.
Xogta cilmi baarista ee ONO-4538-12 waxaa lagu shaaciyay warbixin afka ah oo laga soo saaray shirkii Gastrointestinal Onpology Symposium (ASCOGI) ee San Francisco, California, USA, laga bilaabo 2017: 2 illaa 00: 3 pm ee Janaayo 30 (Abstract No. 19).
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.
"Natiijooyinkani waxay xaqiijinayaan faa'iidada caafimaad ee Nivolumab ee daaweynta kansarka gaaska ee horumarsan ama soo noqnoqda, waxayna siineysaa aasaas adag oo loogu talagalay baaritaanka dheeraadka ah ee Nivolumab ee daaweynta kansarka caloosha," madaxa baaraha kiliinikada, Seoul Asian Medical Center, Jaamacadda Ulsan, Koonfurta Korea Yoon-KooKang, MD iyo MD ee Kulliyadda Caafimaadka ee Oncology, ayaa faallo ka bixiyay.
Ku saabsan cilmi baarista ONO-4538-12
Daraasadda ONO-4538-12 (NCT02267343) waa wejiga III, randomized, double-indhole, daraasad bukaan-socod-koontarool ah oo lagu sameeyay Japan, South Korea, iyo Taiwan. Waxay qiimeeyeen la'aanta (lagama saari karo qaliinka) iyo heerka Nivolumab daawaynta daawaynta waa mid aan waxtar lahayn ama aan loo dulqaadan karin daaweynta bukaanada qaba kansarka caloosha ee horumarsan ama soo noqnoqda (oo ay ku jiraan kansarka isgoysyada gastroesophageal) ee bukaanada leh waxtarka iyo badbaadada. Daraasadda caafimaad waxaa sameeyay shirkadda Japan Ono Pharmaceutical Co., Ltd., oo ah lammaane Bristol-Myers Squibb Nivolumab R & D.
Daraasadda ONO-4538-12, bukaanku waxay heleen nivolumab 3 mg / kg ama placebo hal mar labadii usbuucba illaa iyo inta ay burooyinka ka socdaan ama la joojiyo sunta aan loo dulqaadan karin darteed. OS-ka dhamaadka ugu dambeeya waxaa lagu qiimeeyay waxtarka la xiriira placebo. Meelaha ugu dambeeya ee heerka labaad waxaa ka mid ahaa heerka jawaabta ujeeddada, muddada jawaabta, badbaadada aan horumarka lahayn, wadarta guud ee jawaab celinta, waqtiga jawaabta burooyinka, heerka xakamaynta cudurrada, iyo doorsoomayaasha la xiriira amniga.
Tilmaamaha NIVOLUMAB ee ay ansixisay Maamulka Cuntada iyo Dawooyinka ee Mareykanka (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.
Daawada moniverapi ee loo yaqaan 'Nivolumab monotherapy' ayaa loo isticmaali karaa in lagu daaweeyo nooca duurjoogta ee BRAFV600 ama melanoma metastatic.
Nivolumab oo lagu daray Ipilimumab waxay ku habboon tahay daaweynta bukaannada qaba melanoma aan la daaweyn karin ama metastatic. Iyada oo ku saleysan saameynta cajiibka ah ee daaweynta ku-noolaanshaha horumarka-bilaashka ah, tilmaanta ayaa si dhakhso leh loo oggolaaday. Sii wadida ogolaanshaha tilmaamaha waxaa lagu xukumi doonaa iyadoo lagu saleynayo natiijooyinka faa'iidada caafimaad ee baaritaanka xaqiijinta.
Nivolumab can be used to treat metastatic kansarka sanbabada ee aan yareyn (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 waxa loo isticmaali karaa in lagu daweeyo bukaanada qaba kansarka unugyada kelyaha ee horumaray (RCC) kuwaas oo isticmaalay dawooyinka lidka ku ah angiogenic.
Nivolumab can be used for autologous hematopoietic stem cell transplantation (HSCT) and after transplantation, brentuximabvedotin is used to treat recurrent or progressive classic Lymphoma Hodgkin (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.
