Recens ONO-4538-12 clinica studium emissum in colloquio ASCO-GI monstravit comparatum cum Placebo, Nivolumab periculum mortis aegrorum per 37% redegisse, et altiore 12-mense superstes de aegris cum Nivolumab 26.6% tractatis pervenit. . Solo 12-mense superstes de Placebo-aegris administratis tantum 10.9% erat.
Die 19 Ianuarii 2017, Bristol-Myers Squibb eventus studiorum clinicorum vocati ONO-4538-12 denuntiavit, qui ostendit Nivolumab signanter periculum mortis in aegros redegisse cum cancro gastrico provecto qui inefficax vel intolerans ad curatio normae 37% valebat. (HR0.63; p <0.0001), et in hac curatione pro aegris mensura nulla est. ONO-4538-12 studium periodus III randomized, duplex caecus, moderatus studium clinicum aestimandi efficaciam et salutem Nivolumab in talibus aegris est. Primus finis studii altiore superstes fuit (OS). Mediana OS in Circulo Nivolumab et coetus Placebo fuerunt 5.32 menses (95% CI: 4.63-6.41) et 4.14 menses (95% CI: 3.42-4.86) (p <0.0001). Suprema 12-menses rates superstites coetus Nivolumab et coetus Placebo fuerunt 26.6% (95% CI: 21.1-32.4) et 10.9% (95% CI: 6.2-17.0), respective. Postquam aeger cum Nivolumab tractatus est, secundarius finis responsionis obiectivae 11.2% (95% CI: 7.7-15.6) duravit, et responsionis duratio mediana erat 9.53 mensium (95% CI: 6.14-9.82). Responsio obiectiva rata in circulo placebo erat 0% (95% CI: 0.0-2.8).
Nivolumab’s safety is consistent with previous reports of solid tuberculum 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.
-4538-12 Aquilo investigationis fama notitia nuntiatum oris breakthrough in MMXVII Gastrointestinal in Symposio Scandinavica (ASCOGI) in San Francisco, California, USA, a 2017:2 ad 00:3 in June XIX (Anno No. II).
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.
"Hi praecessi confirmet in orci beneficium ex Nivolumab in curatio de provectus, aut recurrentes, CARDIACUS cancer et providere fortis basis ad ulteriores investigationes ab Nivolumab CARDIACUS cancer curatio," dux orci perscrutator opprimitur a gloria Seoul Asian Medical Center, Ulsan University, meridie Korea, Yoon KooKang, de MD MD Medical College of, et Oncology, annotavit.
De Aquilo investigationis, 4538-12
Studium ONO-4538-12 (NCT02267343) est phase III, randomized, duplicatum caecum, placebo moderatum studium clinicum in Iaponia, Corea Meridiana et Taiwan celebratum. Perpensum est unresectabilitatem (chirurgicam amoveri non potest) et norma curationis Nivolumab therapeuticae inefficax vel intolerans in curatione aegrorum cum cancro gastrico progressivo vel recurrente (incluso cancro gastroesophagico coniunctionis) patientibus efficacia et incolumitate. Studium clinicum per Iaponiae Ono Pharmaceuticum Co, Ltd, a Bristol-Myers Squibb Nivolumab R&D socium deductum est.
In Aquilo studium, 4538-12, III aegris accepit nivolumab mg / kg vel placebo cum omnem tumorem duas hebdomades progressus non fiebat usque ad ferendum ex toxicity. In prima enim commendatur aestimanda est endpoint OS efficaciam habet ad placebo. Secundarium includitur terminos objective responsionem rate, tempus responsionis progressum salvos-liberum, responsum meliorem rate totalis tempus et responsionem tumore, morbus control rate et salutem-related variables.
NIVOLUMAB indication probatus per US Cibus et medicamentis 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 potest esse in type unresectable facies BRAFV600 feram, vel metastatic melanoma.
Nivolumab combined per Ipilimumab est apta curatio de cum aegris aut unresectable metastatic melanoma. Ex mirabiliter effectum ad de Lorem in liberum progressum salvos, et brevi indication est probatus. Quod probat ex continua indication judicetur secundum bonum a orci test eventus confirmans.
Nivolumab can be used to treat metastatic cellula parva non-pulmonis cancer (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 aegros tractare potest cum carcinomate renali provecto (RCC) qui medicamentis anti-angiogenicis usi sunt.
Nivolumab can be used for autologous hematopoietic stem cell transplantation (HSCT) and after transplantation, brentuximabvedotin is used to treat recurrent or progressive classic Hodgkin 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.
