The recent ONO-4538-12 clinical study released at the ASCO-GI conference showed that compared with placebo, Nivolumab reduced the risk of death of patients by 37%, and the overall 12-month survival rate of patients treated with Nivolumab reached 26.6%. The 12-month overall survival rate of placebo-administered patients was only 10.9%.
On January 19, 2017, Bristol-Myers Squibb announced the results of a clinical study called ONO-4538-12, which showed that Nivolumab significantly reduced the risk of death in patients with advanced gastric cancer who were ineffective or intolerant to standard treatment 37% (HR0.63; p <0.0001), and there is currently no standard treatment for such patients. The ONO-4538-12 study is a phase III randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of Nivolumab in such patients. The primary endpoint of the study was overall survival (OS). The median OS in the Nivolumab group and the placebo group were 5.32 months (95% CI: 4.63-6.41) and 4.14 months (95% CI: 3.42-4.86) (p <0.0001). The 12-month overall survival rates of the Nivolumab group and the placebo group were 26.6% (95% CI: 21.1-32.4) and 10.9% (95% CI: 6.2-17.0), respectively. After the patient was treated with Nivolumab, the secondary endpoint objective response rate reached 11.2% (95% CI: 7.7-15.6), and the median duration of response was 9.53 months (95% CI: 6.14-9.82). The objective response rate in the placebo group was 0% (95% CI: 0.0-2.8).
Nivolumab’s safety is consistent with previous reports of solid tumor 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.
Të dhënat e hulumtimit ONO-4538-12 u njoftuan në raportin oral të përparimit të Simpoziumit Onkologjik Gastrointestinal 2017 (ASCOGI) në San Francisco, California, USA, nga ora 2:00 deri në 3:30 pasdite më 19 Janar (Abstrakt Nr. 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.
"Këto rezultate konfirmojnë përfitimin klinik të Nivolumab në trajtimin e kancerit të avancuar ose të përsëritur të stomakut dhe sigurojnë një bazë të fortë për hulumtimin e mëtejshëm të Nivolumab për trajtimin e kancerit të stomakut", hetuesi kryesor klinik, Seoul Asian Medical Center, Universiteti Ulsan, Jug Komentoi Korea Yoon-KooKang, MD dhe MD e Kolegjit Mjekësor të Onkologjisë.
Rreth hulumtimit ONO-4538-12
The ONO-4538-12 study (NCT02267343) is a phase III, randomized, double-blind, placebo-controlled clinical study conducted in Japan, South Korea, and Taiwan. It evaluated the unresectability (cannot be removed by surgery) and standard of Nivolumab Therapeutic treatment is ineffective or intolerant in the treatment of patients with advanced or recurrent gastric cancer (including gastroesophageal junction cancer) in patients with efficacy and safety. The clinical study was conducted by Japan’s Ono Pharmaceutical Co., Ltd., a Bristol-Myers Squibb Nivolumab R & D partner .
Në studimin ONO-4538-12, pacientët morën nivolumab 3 mg / kg ose placebo një herë në dy javë derisa tumori të përparonte ose të ndërpritet për shkak të toksicitetit të patolerueshëm. OS përfundimtar i pikës përfundimtare u vlerësua për efektivitetin në krahasim me placebo. Pikat përfundimtare dytësore përfshinin shkallën e përgjigjes objektive, kohëzgjatjen e përgjigjes, mbijetesën pa progresion, shkallën optimale totale të përgjigjes, kohën për përgjigjen e tumorit, shkallën e kontrollit të sëmundjes dhe variablat që lidhen me sigurinë.
Treguesi NIVOLUMAB i aprovuar nga Administrata Amerikane e Ushqimit dhe Barnave (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.
Monoterapia me nivolumab mund të përdoret për të trajtuar BRAFV600 melanomë të parezikshme ose metastatike të tipit të egër.
Nivolumab i kombinuar me Ipilimumab është i përshtatshëm për trajtimin e pacientëve me melanomë të parezikueshme ose metastatike. Bazuar në efektin e shquar të terapisë në mbijetesën pa progresion, indikacioni u aprovua shpejt. Miratimi i vazhdueshëm i indikacionit do të gjykohet bazuar në rezultatet e përfitimit klinik të testit konfirmues.
Nivolumab can be used to treat metastatic kanceri i mushkërive me qeliza jo të vogla (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 mund të përdoret për të trajtuar pacientët me karcinomë të avancuar të qelizave renale (RCC) të cilët kanë përdorur barna anti-angiogjene.
Nivolumab can be used for autologous hematopoietic stem cell transplantation (HSCT) and after transplantation, brentuximabvedotin is used to treat recurrent or progressive classic Limfoma e 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.
