Development status of ONO-4538(nivolumab)1
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2 Development status of ONO-4538(nivolumab)1 Development Code Target Disease JAPAN US/EU KOR/TAI ONO-4538 Melanoma(2 nd ~) Launched Launched (US) Filing (EU) Approved(KOR) Filing(TAI) ONO-4538 Melanoma(1 st ) (combination with Ipilimumab) ONO-4538 Non-small cell lung cancer(2 nd ~) Filing Ⅱ Ⅲ - Launched (US) Filing (EU) Ⅱ(KOR) Filing(TAI) ONO-4538 Non-small cell lung cancer(1 st ) Ⅲ Ⅲ Ⅲ ONO-4538 Renal cell carcinoma(2 nd ) Ⅲ Ⅲ - ONO-4538 Renal cell carcinoma(1 st ) (combination with Ipilimumab) Ⅲ Ⅲ - ONO-4538 Head and neck carcinoma Ⅲ Ⅲ Ⅲ ONO-4538 Gastric cancer Ⅲ Ⅰ/Ⅱ Ⅲ ONO-4538 Glioblastoma - Ⅲ - yellow:up-date after Nov /14
3 Development status of ONO-4538(nivolumab)2 Development Code ONO-4538 Diffuse large B cell lymphoma ( Non-Hodgkin lymphoma ) Target Disease US/EU JAPAN Ⅱ(BMS) ONO-4538 Follicular lymphoma( Non-Hodgkin lymphoma ) Ⅱ(BMS) - ONO-4538 Hodgkin lymphoma Ⅱ(BMS) Ⅱ ONO-4538 Esophageal cancer - Ⅱ ONO-4538 Ovarian cancer( investigator initiated trial ) - Ⅱ ONO-4538 Bladder cancer Ⅱ(BMS) - ONO-4538 Colon cancer Ⅰ/Ⅱ(BMS) - ONO-4538 Pancreatic cancer, Small cell lung cancer, Triple negative breast cancer, Bladder cancer Ⅰ/Ⅱ(BMS) ONO-4538 Hepatocellular carcinoma Ⅰ(BMS) Ⅰ ONO-4538 Hematologic malignancies Ⅰ(BMS) - ONO-4538 Chronic myelogenous leukemia Ⅰ(BMS) - red : Hematologic malignancies - - 3/14
4 Combination clinical trials (OPDIVO & other I-O compounds) Company Combination Cancer type Phase Area Renal cell carcinoma Ⅲ US,EU JP BMS Nivolumab+Ipilimumab Melanoma Ⅲ Ⅱ US JP BMS BMS BMS Kyowa Hakko Kirin Nivolumab+Lirilumab (Anti-KIR antibody) Nivolumab+BMS (Anti-LAG-3 antibody) Nivolumab+Urelumab (CD137 receptor agonist) Nivolumab+ Mogamulizumab Solid tumor Ⅰ US Solid tumor Solid tumor, Non-Hodgkin lymphoma Ⅰ Ⅰ/Ⅱ US, EU US, EU Solid tumor Ⅰ JP 4/14
5 Survival Benefit of OPDIVO for Melanoma Hodi FS, N Engl J Med dacarbazine OPDIVO(nivolumab) dacarvadine nivolumab 12M survival rate 42.1 % 72.9 % 5/14
6 OPDIVO:NSCLC(Squamous) Overall Survival(OS) OPDIVO(nivolumab) docetaxel HR=0.59, P = 薬剤 OS 中央値 nivolumab 9.2M docetaxel 6.0M 6/14
7 Medical Treatment Flow for NSCLC previously untreated patient about70~80% non-squamous squamous about20~30% about10~40% EGFR mutation positive about60~90% EGFR mutation negative or unknown 1 st line EGFR-TKI platinum-based doublet chemotherapy 2 nd line 3 rd line platinum-based doublet chemotherapy EGFR-TKI docetaxel, gemcitabine, pemetrexed docetaxel, gemcitabine, pemetrexed, etc. :this time, the group ONO-4538(mono therapy)aims the additional indication :the future, the group ONO-4538(combination or mono therapy)aims the additional indication EGFR: epidermal growth factor receptor, TKI: tyrosine kinase inhibitor *:In case ALK translocation is positive, the treatment with ALK inhibitor as mono therapy is recommended. (Japan Lung Cancer Society, Lung Cancer Medical Treatment Guideline 2012) 7/14
8 Comprehensive medical treatment for cancer patients Supportive care Emend/Proemend nausea and vomiting ONO-7643 cancer cachexia Lirilumab ( Anti-KIR antibody) BMS ( Anti-LAG3 antibody) Urelumab ( CD137 receptor agonist) Ipilimumab Melanoma NSCLC etc. Mogamulizumab CCR4 antibody ONO-7057 ( Carfilzomib ) Multiple myeloma OPDIVO (Nivolumab) Lung Cancer RCC Melanoma Gastric Cancer Hepatocellular carcinoma Hematologic malignancies ONO-7056 Pancreatic cancer etc. etc. Anticancer drug ONO-4059 B cell lymphoma ONO-7268MX1,2 Hepatocellular carcinoma etc. ONO-7058 Hematologic malignancies 8/14
9 Planned presentation about nivolumab in ASCO 2015:overseas clinical trial Non small lung cancer An ongoing phase IIIb/IV safety trial of nivolumab (NIVO) in patients (pts) with advanced or metastatic non-small-cell lung cancer (NSCLC) who progressed after receiving 1 or more prior systemic regimens. A phase III study (CheckMate 017) of nivolumab (NIVO; anti-programmed death-1 [PD-1]) vs docetaxel (DOC) in previously treated advanced or metastatic squamous (SQ) cell non-small cell lung cancer (NSCLC). Phase III, randomized trial (CheckMate 057) of nivolumab (NIVO) versus docetaxel (DOC) in advanced non-squamous cell (non-sq) non-small cell lung cancer (NSCLC). First-line monotherapy with nivolumab (NIVO; anti-programmed death-1 [PD-1]) in advanced non-small cell lung cancer (NSCLC): Safety, efficacy and correlation of outcomes with PD-1 ligand (PD-L1) expression. Renal cell cancer Immunomodulatory activity of nivolumab in metastatic renal cell carcinoma (mrcc): Association of biomarkers with clinical outcomes. Updated survival results from a randomized, dose-ranging phase II study of nivolumab (NIVO) in metastatic renal cell carcinoma (mrcc). Expanded cohort results from CheckMate 016: A phase I study of nivolumab in combination with ipilimumab in metastatic renal cell carcinoma (mrcc). Melanoma Efficacy and safety results from a phase III trial of nivolumab (NIVO) alone or combined with ipilimumab (IPI) versus IPI alone in treatment-naive patients (pts) with advanced melanoma (MEL) (CheckMate 067). Effect of nivolumab (NIVO) on quality of life (QoL) in patients (pts) with treatment-naïve advanced melanoma (MEL): Results of a phase III study (CheckMate 066). Survival, biomarker, and toxicity analysis of nivolumab (NIVO) in patients that progressed on ipilimumab (IPI). Effect of nivolumab (NIVO) in combination with ipilimumab (IPI) versus IPI alone on quality of life (QoL) in patients (pts) with treatment-naïve advanced melanoma (MEL): Results of a phase II study (CheckMate 069). 9/14
10 Planned presentation about nivolumab in ASCO 2015:overseas clinical trial Melanoma(continued) Safety profile of nivolumab (NIVO) in patients (pts) with advanced melanoma (MEL): A pooled analysis. Clinical response, progression-free survival (PFS), and safety in patients (pts) with advanced melanoma (MEL) receiving nivolumab (NIVO) combined with ipilimumab (IPI) vs IPI monotherapy in CheckMate 069 study. Nivolumab in resected and unresectable melanoma: Immune-related adverse events and association with survival outcomes Hepatocellular carcinoma Phase I/II safety and antitumor activity of nivolumab in patients with advanced hepatocellular carcinoma (HCC): CA Small cell lung cancer Phase I/II study of nivolumab with or without ipilimumab for treatment of recurrent small cell lung cancer (SCLC): CA Glioblastoma Preliminary safety and activity of nivolumab and its combination with ipilimumab in recurrent glioblastoma (GBM): CHECKMATE /14
11 Planned presentation about nivolumab in ASCO 2015:clinical trial in Japan Non small cell lung cancer Phase II studies of nivolumab (anti-pd-1, BMS , ONO-4538) in patients with advanced squamous (sq) or nonsquamous (non-sq) non-small cell lung cancer (NSCLC). Ovarian cancer Durable tumor remission in patients with platinum-resistant ovarian cancer receiving nivolumab. 11/14 11/7
12 Development Code Global Development Projects Target Disease Overseas* JAPAN* ONO-6950 Bronchial asthma Ⅱ Ⅱ ONO-4053 Allergic rhinitis Ⅱ Ⅱ ONO-2952 Irritable bowel syndrome (IBS) Ⅱ - ONO-9054 Glaucoma, Ocular hypertension Ⅱ - ONO-4059 B-cell lymphoma Ⅰ Ⅰ 海外 ( 欧米 ) で 2 化合物以上の上市 ( 導出 ) ONO-8055 Underactive bladder Ⅰ - ONO-2160/CD Parkinson s disease - Ⅰ 現在のグローバル開発品状況一覧表 *The most advanced stage is shown ONO-1266 Portal hypertension Ⅰ - ONO-4232 Acute heart failure Ⅰ - ONO-4474 Osteoarthrosis Ⅰ - 12/14
13 Development pipeline list in Japan(1) Development code /Product name/product candidate name Opalmon (additional formulation) Rivastach Patch (Additional dosing regimen) Proemend (pediatric) Planned indication Thromboangiitis obliterans, Lumbar spinal stenosis Dementia of the Alzheimer s type Chemotherapy-induced nausea and vomiting JAPAN L a u n c h e d F i l i n g ONO-4164IV (Orencia IV) Juvenile idiopathic arthritis Ⅲ ONO-4164IV (Orencia IV) Lupus nephritis Ⅲ ONO-7057 (Carfilzomib) Multiple myeloma Ⅲ ONO-5163 Secondary hyperparathyroidism Ⅲ Onoact (pediatric) Tachyarrhythmia in low cardiac function *The most advanced stage is shown Ⅲ Ⅱ /Ⅲ 13/14
14 Development pipeline list in Japan(2) *The most advanced stage is shown Development code /Product name/product candidate name Planned indication JAPAN ONO-7643 Cancer cachexia Ⅱ ONO-1162 Chronic heart failure Ⅱ ONO-6950 Bronchial asthma Ⅱ ONO-4053 Allergic rhinitis Ⅱ ONO-7056 Solid Tumor Ⅰ ONO-7268MX1 Hepatocellular carcinoma Ⅰ ONO-7268MX2 Hepatocellular carcinoma Ⅰ ONO-2160/CD(levodopa pro-drug) Parkinson s disease Ⅰ ONO-2370(COMT inhibitor) Parkinson s disease Ⅰ ONO-4059 B-cell lymphoma Ⅰ 14/14
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