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 tumo 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.
Bayanin bincike na ONO-4538-12 an sanar da shi a cikin rahoton ci gaban da aka samu na 2017 Gastrointestinal Oncology Symposium (ASCOGI) a San Francisco, California, Amurka, daga 2:00 zuwa 3:30 pm a ranar 19 ga Janairu (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.
"Waɗannan sakamakon sun tabbatar da fa'idodin asibiti na Nivolumab wajen kula da ci gaba ko maimaita cutar kansa, kuma suna ba da tushe mai ƙarfi don ci gaba da bincike game da Nivolumab don maganin cutar kansa," babban mai binciken asibiti, Cibiyar Kiwon Lafiya ta Asiya ta Seoul, Jami'ar Ulsan, Kudancin Korea Yoon-KooKang, MD da MD na Kwalejin Kiwon Lafiyar Oncology, sun yi tsokaci.
Game da binciken 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 .
A cikin nazarin ONO-4538-12, marasa lafiya sun karɓi nivolumab 3 mg / kg ko placebo sau ɗaya a kowane mako biyu har sai ciwowar ta ci gaba ko dakatar da ita saboda cutar mai guba. An kimanta ƙarshen ƙarshen OS don tasiri dangane da placebo. Arshen ƙarshen sakandare sun haɗa da ƙimar amsawa na haƙiƙa, tsawon lokacin amsawa, rashin ci gaba na ci gaba, ƙimar jimlar amsawa mafi kyau duka, lokaci zuwa martani na ƙari, saurin cutar, da masu canji masu alaƙa da aminci.
NIVOLUMAB alamar da Hukumar Abinci da Magunguna ta Amurka (FDA) ta amince da ita
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.
Za a iya amfani da monoprapy na Nivolumab don magance BRAFV600 nau'in daji wanda ba shi da tabbas ko melanoma na metastatic.
Nivolumab haɗe tare da Ipilimumab ya dace don kula da marasa lafiya tare da rashin ƙoshin lafiya ko melanoma mai haɗari. Dangane da tasirin tasiri na farfadowa akan rayuwa ba tare da cigaba ba, an yarda da nuni da sauri. Ci gaba da amincewa da nuni za a yi hukunci gwargwadon sakamakon fa'idar asibiti na gwajin tabbatarwa.
Nivolumab can be used to treat metastatic cututtukan daji na kansa marasa kansar (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.
Ana iya amfani da Nivolumab don kula da marasa lafiya tare da ci-gaba na renal cell carcinoma (RCC) waɗanda suka yi amfani da magungunan anti-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 na 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.
