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.
Data panilitian ONO-4538-12 diumumkeun dina laporan lisan terobosan tina 2017 Gastrointestinal Oncology Symposium (ASCOGI) di San Francisco, California, AS, ti 2:00 dugi ka 3:30 pm tanggal 19 Januari (Abstrak 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.
"Hasil ieu mastikeun manpaat klinis Nivolumab dina pengobatan kanker lambung maju atanapi kumat, sareng nyayogikeun dasar anu kuat pikeun panilitian salajengna ngeunaan Nivolumab pikeun pangobatan kanker lambung," lulugu penyidik klinis, Seoul Medical Medical Center, Ulsan University, South Koréa Yoon-KooKang, MD sareng MD ti Médis College of Oncology, mairan.
Ngeunaan ONO-4538-12 panalungtikan
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 .
Dina ulikan ONO-4538-12, penderita nampi nivolumab 3 mg / kg atanapi plasebo sakali unggal dua minggu dugi ka tumor maju atanapi dieureunkeun kusabab karacunan anu teu kaampeuh. OS endpoint primér dievaluasi pikeun efektivitas relatif ka plasebo. Titik titik sekundér kalebet tingkat réspon objektif, durasi réspon, salamet bébas tina kamajuan, tingkat réspon total optimal, waktos réspon tumor, tingkat kontrol panyakit, sareng variabel anu patali sareng kaamanan.
Indikasi NIVOLUMAB disatujuan ku Administrasi Pangan sareng Narkoba AS (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 bisa dipaké pikeun ngubaran BRAFV600 liar-tipe unresectable atanapi mélanoma métastatik.
Nivolumab digabungkeun sareng Ipilimumab cocog pikeun pangobatan pasién anu melesok atanapi metastatik melanoma. Dumasar kana pangaruh anu luar biasa tina terapi kana salamet bébas tina kamajuan, indikasi na gancang disatujuan. Persetujuan anu teras tina indikasi bakal ditilik dumasar kana hasil kauntungan klinis tina tés konfirmasi.
Nivolumab can be used to treat metastatic kanker paru sél non-leutik (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 bisa dipaké pikeun ngubaran penderita carcinoma sél renal canggih (RCC) anu geus dipaké ubar 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 Limfoma 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.
