Development status of OPDIVO (nivolumab) 1
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1 August 1, 2018
2 Development status of OPDIVO (nivolumab) 1 Target disease JAPAN US/EU KR/TW Melanoma (1 st ) Approved Approved Approved Melanoma (Adjuvant Therapy) Filing Approved (US) Non-small cell lung cancer (2 nd ~) Approved Approved Approved Non-small cell lung cancer (1 st ) Filing(US) Renal cell carcinoma (2 nd ~) Approved Approved Approved Renal cell carcinoma (1 st ) Filing Approved (US) Hodgkin lymphoma Approved Approved Approved Head and neck carcinoma Approved Approved Approved Urothelial cancer Approved Approved Gastric cancer Approved Approved Gastro-esophageal junction cancer and esophageal cancer Small cell lung cancer Hepatocellular carcinoma Filing (US) (EU) Approved (US) (EU) (KR) Approved (TW) Esophageal cancer Glioblastoma - Red : Hematologic malignancy 2/18
3 Development status of OPDIVO (nivolumab) 2 Target disease JAPAN US/EU KR/TW Multiple myeloma Ⅱ - Malignant pleural mesothelioma Filing - Ovarian cancer - Colorectal cancer Ⅱ/ Approved (US) Ⅱ/(EU) - Central nervous system lymphoma, Primary Testicular Lymphoma Ⅱ Ⅱ - Cervix carcinoma, Uterine body cancer, Soft tissue sarcoma Ⅱ - - Pancreatic cancer Ⅱ Ⅱ Ⅱ Diffuse large B cell lymphoma (Non-Hodgkin lymphoma) - Ⅱ - Follicular lymphoma (Non-Hodgkin lymphoma) - Ⅱ - Prostate cancer - Ⅱ - Virus positive/negative solid carcinoma Ⅰ/Ⅱ Ⅰ/Ⅱ Ⅰ/Ⅱ Pancreatic cancer, Triple negative breast cancer (CheckMate-032 study) - Ⅰ/Ⅱ - Biliary tract cancer Ⅰ - - Chronic myeloid leukemia - Ⅰ - Red : Hematologic malignancy 3/18
4 Clinical trials in combination therapy OPDIVO (nivolumab) & other I-O compounds 1 Combination therapy Cancer type Japan US/EU KR/TW Melanoma Approved Approved Approved Renal cell carcinoma Non-small cell lung cancer Filing Approved(US) Filing(US) Small cell lung cancer Nivolumab + Ipilimumab Head and neck cancer Gastric cancer Malignant pleural mesothelioma - Esophageal cancer Urothelial cancer Colorectal cancer - Approved(US) Ⅱ(EU) Ovarian cancer - Ⅰ/Ⅱ - Virus positive/negative solid carcinoma Ⅰ/Ⅱ Ⅰ/Ⅱ Ⅰ/Ⅱ - 4/18
5 Clinical trials in combination therapy OPDIVO (nivolumab) & other I-O compounds 2 Combination therapy with nivolumab Cancer type Japan US/EU KR/TW ONO-4687/Cabiralizumab (Anti-CSF-1R antibody) ONO-7701 (IDO1 inhibitor) ONO-4686 (Anti-TIGIT antibody) ONO-7807 (Anti-TIM-3 antibody) ONO-4482/Relatlimab (Anti-LAG-3 antibody) ONO-4483/Lirilumab (Anti-KIR antibody) ONO-4481/Urelumab (CD137 receptor agonist) Mogamulizumab (Anti-CCR4 antibody) Pancreatic cancer Ⅱ Ⅱ Ⅱ Solid tumor, Hematologic malignancy Ⅰ Ⅰ - Melanoma - Solid tumor, Hematologic malignancy Ⅰ Ⅰ/Ⅱ - Solid tumor Ⅰ/Ⅱ Ⅰ/Ⅱ - Solid tumor Ⅰ/Ⅱ Ⅰ/Ⅱ - Melanoma Ⅰ/Ⅱ - - Solid tumor Ⅰ Ⅰ/Ⅱ - Solid tumor Ⅰ Ⅰ/Ⅱ - Solid tumor Ⅰ Ⅰ/Ⅱ - Solid tumor Ⅰ Ⅰ/Ⅱ - 5/18
6 Development pipeline in Japan (Oncology,other than OPDIVO) Product name/its candidate /development code Target indication Japan ONO-7702 (Encorafenib) Melanoma Filing ONO-7703 (Binimetinib) Melanoma Filing ONO-5371 (Metyrosine) Pheochromocytoma Filing KYPROLIS (Change in dosage and administration) Multiple myeloma ONO-7643 (Anamorelin) Cancer anorexia/cachexia (in all types of cancer) ONO-7702 (Encorafenib) Colorectal cancer ONO-7703 (Binimetinib) Colorectal cancer ONO-7701 (BMS ) Melanoma ONO-4687 (Cabiralizumab) Pancreatic cancer Ⅱ ONO-4686 (BMS ) Solid tumor Ⅰ / Ⅱ ONO-4059 (Tirabrutinib) Central nervous system lymphoma Ⅰ / Ⅱ ONO-4482 (Relatlimab) Melanoma Ⅰ / Ⅱ ONO-7807 (BMS ) Solid tumor Ⅰ / Ⅱ ONO-4481 (Urelumab) Solid tumor Ⅰ ONO-4483 (Lirilumab) Solid tumor Ⅰ ONO-4578 Solid tumor Ⅰ ONO-7705 Multiple myeloma,non-hodgkin lymphoma Ⅰ 6/18
7 Development pipeline in Japan (Non-oncology) Product name/its candidate /development code Target indication Japan Onoact (Additional indication) Ventricular arrhythmia Filing Orencia IV (Additional indication) Lupus nephritis Orencia SC (Additional indication) Untreated rheumatoid arthritis Orencia SC (Additional indication) Primary Sjögrens syndrome Orencia SC (Additional indication) Polymyositis / Dermatomyositis ONO-1162 (Ivabradine) Chronic heart failure ONO-5704 (SI-613) Osteoarthritis Onoact (Pediatric) Tachyarrhythmia in low cardiac function Ⅱ / Onoact (Additional indication) Tachyarrhythmia upon sepsis Ⅱ / ONO-2370 (Opicapone) Parkinson s disease Ⅱ ONO-5704 (SI-613) Enthesopathy Ⅱ Opdivo (Additional indication) Sepsis Ⅰ / Ⅱ ONO-4059 (Tirabrutinib) Autoimmune disease Ⅰ 7/18
8 Global development projects (Other than OPDIVO) Development code /Generic name ONO-7702 (Encorafenib) ONO-7703 (Binimetinib) ONO-4059 (Tirabrutinib) Target indication /Pharmacological Action Phase Area Colorectal cancer / BRAF inhibitor KR Melanoma / BRAF inhibitor KR Colorectal cancer / MEK inhibitor KR Melanoma / MEK inhibitor KR B cell lymphoma / Btk inhibitor Ⅱ EU Sjögrens syndrome / Btk inhibitor Ⅱ US/EU ONO-4687 (Cabiralizumab) Pancreatic cancer / Anti-CSF-1R antibody Ⅱ KR/TW ONO-4059 (Tirabrutinib) B cell lymphoma / Btk inhibitor Ⅰ US ONO-7475 Acute leukemia / Axl / Mer inhibitor Ⅰ US ONO-5788 Acromegaly / Growth hormone secretion inhibitor Ⅰ US 8/18
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