Development status of ONO-4538(nivolumab)1
|
|
|
- Melissa Kelley
- 6 years ago
- Views:
Transcription
1
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 = median OS 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 Lirilumab ( Anti-KIR antibody) Ipilimumab Melanoma NSCLC etc. ONO-7057 ( Carfilzomib ) Multiple myeloma OPDIVO Anticancer drug ONO-4059 B cell lymphoma nausea and vomiting ONO-7643 cancer cachexia BMS ( Anti-LAG3 antibody) Urelumab ( CD137 receptor agonist) (Nivolumab) Lung Cancer RCC Melanoma Gastric Cancer Hepatocellular carcinoma Hematologic malignancies etc. ONO-7056 Pancreatic cancer etc. 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 Launched Filing 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
15 Cancer Number of Cancer Patients Incident per year Mortality per year Japan Korea USA EU Japan Korea USA EU Oesophagus 19,683 2,223 16,968 45,983 12,440 1,551 15,982 39,523 Stomach 107,898 31,269 21, ,667 52,326 10,746 11, ,314 Colorectum 112,675 33, , ,136 49,345 9,169 55, ,814 Liver 36,168 16,900 30,449 63,462 32,518 12,275 24,312 62,175 Gallbladder 21,417 5,228 9,431 29,744 19,309 4,176 3,845 20,877 Pancreas 32,899 5,379 42, ,845 31,046 5,086 41, ,535 Larynx 3,615 1,087 12,373 39, ,880 19,772 Lung 94,855 22, , ,220 75,119 17, , ,723 Melanoma of skin 1, , , ,224 22,212 Breast 55,710 17, , ,202 13,801 2,274 43, ,257 Cervix uteri 9,390 3,299 12,966 58,373 3,645 1,113 6,605 24,385 Corpus uteri 11,449 2,016 49,645 98,984 2, ,925 23,733 Ovary 8,921 2,349 20,874 65,584 4,986 1,054 15,377 42,737 Prostate 55,970 10, , ,137 11,644 1,696 30,383 92,318 Kidney 16,830 5,651 58, ,252 8,124 1,264 14,900 48,988 Bladder 22,042 4,097 68, ,297 7,630 1,330 16,468 52,395 Brain, nervous 5,510 1,978 21,611 57,132 2,229 1,270 15,746 45,003 Thyroid 9,290 32,992 52,126 52,956 1, ,965 6,334 Hodgkin lymphoma 1, ,601 17, ,295 4,622 Non-hodgkin lymphoma 20,978 4,717 63,066 93,518 11,157 1,611 21,732 37,886 Multiple myeloma 4,984 1,317 19,626 38,956 4, ,978 24,296 Leukaemia 10,182 3,002 39,658 82,329 8,583 1,751 24,729 53,796 WHO GLOBOCAN 2012
Development status of ONO-4538(nivolumab)1
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
Changes from Third Quarter Flash Report for the Fiscal Year ending March 2015 announced on February 3, 2015 *1: Marketing authorization of Onoact 150
Annual Flash Report (unaudited) Fiscal Year ended March 31, 2015 Supplemental Information Status of Development Pipeline as of May 12, 2015 I. Main Pipelines Other than ONO-4538 ⅰ. Developments Status
Development status of OPDIVO (nivolumab) 1
August 1, 2018 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
Development status of OPDIVO (nivolumab) 1
November 2, 2018 Development status of OPDIVO (nivolumab) 1 Target disease JAPAN US/EU KR/TW Melanoma (1 st ) Approved Approved Approved Melanoma (Adjuvant Therapy) Approved Approved(EU) Non-small cell
Development Pipeline Progress Status. February 1, 2019
Development Pipeline Progress Status February 1, 2019 /9 Development status of OPDIVO (nivolumab) (1) Target disease JAPAN US/EU KR/TW Melanoma (1 st ) Approved Approved Approved Melanoma (Adjuvant Therapy)
Annual Flash Report (unaudited) Fiscal Year ended March 31, 2017
Annual Flash Report (unaudited) Fiscal Year ended March 31, 2017 Supplemental nation Status of Development Pipeline as of May 8, 2017. Main Status of Development Pipelines (Oncology) 1. Development Status
ASCO 2014 Highlights*
ASCO 214 Highlights* Investor Meeting June 2, 214 *American Society of Clinical Oncology, May 3 June 3, 214 Forward-Looking Information During this meeting, we will make statements about the Company s
Development status of OPDIVO (nivolumab) 1
May 12, 2017 Development status of OPDIVO (nivolumab) 1 Target disease JAPAN US/EU KR/TW Melanoma (1 st ) Approved Approved Approved Non-small cell lung cancer (2 nd ~) Approved Approved Approved *) Non-small
Citi Global Healthcare Conference
Citi Global Healthcare Conference Francis Cuss, MB BChir, FRCP Chief Scientific Officer February 24, 2014 1 Forward-Looking Information During this meeting, we will make statements about the Company s
The Current Status of Immune Checkpoint Inhibitors: Arvin Yang, MD PhD Oncology Global Clinical Research Bristol-Myers Squibb
The Current Status of Immune Checkpoint Inhibitors: A Global Overview of the Field Arvin Yang, MD PhD Oncology Global Clinical Research Bristol-Myers Squibb Immune Checkpoint Inhibitors Conference, March
Annual Flash Report (unaudited) Fiscal Year ended March 31, 2015 ONO PHARMACEUTICAL CO., LTD. May 12, 2015 Ono Pharmaceutical Co., Ltd. ("The Company"
ONO PHARMACEUTICAL CO., LTD. May 12, 2015 Ono Pharmaceutical Co., Ltd. ("The Company") has announced its consolidated financial results ended March 31, 2015. The consolidated financial statements have
ESMO 2016 * Investor Meeting October 9, *European Society of Medical Oncology, October 7-11, 2016 ESMO 2016 NOT FOR PRODUCT PROMOTIONAL USE
ESMO 2016 * Investor Meeting October 9, 2016 *European Society of Medical Oncology, October 7-11, 2016 1 Forward-Looking Information During this meeting, we will make statements about the Company s future
Consolidated Financial Forecast for the Year Ending March 31,2014 Year ending March 31,2014 Net sales 148,300 $ 1,412,381 Operating income 27, ,
ONO PHARMACEUTICAL CO., LTD. February 4, 2014 Ono Pharmaceutical Co., Ltd. has announced its consolidated financial results for nine months ended December 31, 2013. This First - Third Quarter Flash Report
SUPPLEMENTARY INFORMATION
SUPPLEMENTARY NFORMATON n format provided by Melero et al. (AUGUST 2015) Supplementary nformation S3 Combinations including two or more immunotherapy agents based on PD-1/PD-L1 blockade. (Source: https://clinicaltrials.gov/
Partnering Activity Update
Partnering Activity Update February 2, 2018 Recent Partnering Date Product name / code number Indication / MOA Phase (JP / Overseas) Partner 2010 KYPROLIS / Carfilzomib Multiple Myeloma / Proteasome inhibitor
JP Morgan Healthcare Conference
JP Morgan Healthcare Conference Lamberto Andreotti Chief Executive Officer January 14, 2014 Forward-Looking Information During this meeting, we will make statements about the Company s future plans and
Immune Checkpoint Inhibitors: The New Breakout Stars in Cancer Treatment
Immune Checkpoint Inhibitors: The New Breakout Stars in Cancer Treatment 1 Introductions Peter Langecker, MD, PhD Executive Medical Director, Global Oncology Clinipace Worldwide Mark Shapiro Vice President
Attached from the following page is the press release made by BMS for your information.
June 2, 2015 Opdivo (nivolumab) Demonstrates Superior Survival Compared to Standard of Care (docetaxel) for Previously-Treated Squamous Non-Small Cell Lung Cancer in Phase III Trial (PRINCETON, NJ, May
Immuno-Oncology Applications
Immuno-Oncology Applications Lee S. Schwartzberg, MD, FACP West Clinic, P.C.; The University of Tennessee Memphis, Tn. ICLIO 1 st Annual National Conference 10.2.15 Philadelphia, Pa. Financial Disclosures
We re Reaching Ludicrous Speed: New Immunotherapy Oncology Medications
We re Reaching Ludicrous Speed: New Immunotherapy Oncology Medications Adam Peele, PharmD, BCPS, BCOP Oncology Pharmacy Manager Cone Health Disclosures Merck Pharmaceuticals Speaker s Bureau 1 Objectives
(generic name: ipilimumab) Injection 50 mg ( Yervoy ), a human anti-human CTLA-4 monoclonal. August 21, 2018
August 21, 2018 Opdivo Approved for Supplemental Applications for Expanded Indications of Malignant Pleural Mesothelioma and Adjuvant Treatment of Melanoma, Change in Dosage and Administration (D&A) of
First Phase 3 Results Presented for a PD-1 Immune Checkpoint Inhibitor
September 30, 2014 Positive Phase 3 Data for Opdivo (nivolumab) in Advanced Melanoma Patients Previously Treated with Yervoy @ (ipilimumab) Presented at the ESMO 2014 Congress First Phase 3 Results Presented
Cowen Health Care Conference
Cowen Health Care Conference Dr. Fouad Namouni Head of Medical March 7, 2016 1 Forward-Looking Information This presentation contains statements about the Company s future plans and prospects that constitute
La revolución de la inmunoterapia: dónde la posicionamos? Javier Puente, MD, PhD
La revolución de la inmunoterapia: dónde la posicionamos? Javier Puente, MD, PhD Hospital Universitario Clinico San Carlos Medical Oncology Department Thoracic & Urological Cancer Unit Complutense University
ASCO 2016 * Investor Meeting June 4, *American Society of Clinical Oncology, June 3-7, 2016 ASCO 2016 NOT FOR PRODUCT PROMOTIONAL USE
ASCO 2016 * Investor Meeting June 4, 2016 *American Society of Clinical Oncology, June 3-7, 2016 1 Forward-Looking Information During this meeting, we will make statements about the Company s future plans
FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung Cancer
March 5, 2015 FDA Approves Opdivo (nivolumab) for the Treatment of Patients with Previously Treated Metastatic Squamous Non-Small Cell Lung Cancer (PRINCETON, NJ, March 4, 2015) Bristol-Myers Squibb Company
U.S. Food and Drug Administration Accepts Supplemental Biologics License Application. for Opdivo (nivolumab)
September 3, 2015 U.S. Food and Drug Administration Accepts Supplemental Biologics License Application for Opdivo (nivolumab) in Previously Treated Non-Squamous Non-Small Cell Lung Cancer Patients (PRINCETON,
Out of 129 patients with NSCLC treated with Nivolumab in a phase I trial, the OS rate at 5-y was about 16 %, clearly higher than historical rates.
6th Meeting on external quality assessment in molecular pathology, Naples, May 12-13, 2017 Overview of clinical development of checkpoint inhibitors in solid tumors Pr Jaafar BENNOUNA University of Nantes
ICLIO National Conference
ICLIO National Conference Immuno-oncology In The Clinic Today Lee Schwartzberg, MD, FACP Executive Director, West Cancer Center Chief, Division of Hematology/Oncology University of Tennessee Health Science
Checkpoint Regulators Cancer Immunotherapy takes centre stage. Dr Oliver Klein Department of Medical Oncology 02 May 2015
Checkpoint Regulators Cancer Immunotherapy takes centre stage Dr Oliver Klein Department of Medical Oncology 02 May 2015 Adjuvant chemotherapy improves outcome in early breast cancer FDA approval of Imatinib
Newest Oncology Agents: PD 1 Inhibitors Clinical Information and Patient Management
Newest Oncology Agents: PD 1 Inhibitors Clinical Information and Patient Management Stacey Jassey Megan Brafford David Kwasny This CE activity was originally presented live at the 2015 NASP Annual Meeting
National Cancer Statistics in Korea, 2014
National Cancer Statistics in Korea, 2014 2016. 12. 20. Korea Central Cancer Registry Cancer Incidence in Korea, 2014 National Cancer Incidence, 2014 Trends in Cancer Incidence by Sex and Year * Dark colored
The Immunotherapy of Oncology
The Immunotherapy of Oncology The 30-year Overnight Success Story M Avery, BIOtech Now 2014 Disclosures: Geoffrey R. Weiss, M.D. None The History A. Chekov: It has long been noted that the growth of malignant
CheckMate 012: Safety and Efficacy of First Line Nivolumab and Ipilimumab in Advanced Non-Small Cell Lung Cancer
CheckMate 12: Safety and Efficacy of First Line Nivolumab and Ipilimumab in Advanced Non-Small Cell Lung Cancer Abstract 31 Hellmann MD, Gettinger SN, Goldman J, Brahmer J, Borghaei H, Chow LQ, Ready NE,
Attached from the following page is the press release made by BMS for your information.
September 28, 2015 Opdivo (nivolumab) Demonstrates Superior Overall Survival in a Phase 3 Trial Compared to Standard of Care in Patients with Previously Treated Advanced Renal Cell Carcinoma (PRINCETON,
MERCK ONCOLOGY OVERVIEW AACR 2018 APRIL 16, 2018
MERCK ONCOLOGY OVERVIEW AACR 2018 APRIL 16, 2018 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the company ) includes
Attached from the following page is the press release made by BMS for your information.
June 22, 2015 European Commission Approves Bristol-Myers Squibb s Opdivo (nivolumab), the First and Only PD-1 Checkpoint Inhibitor Approved in Europe, for Both First-Line and Previously-Treated Advanced
Title Cancer Drug Phase Status
Clinical Trial Identifier Title Cancer Drug Phase Status NCT01164995 Study With Wee-1 Inhibitor MK-1775 and Carboplatin to Treat p53 Mutated Refractory and Resistant Ovarian Cancer Epithelial Ovarian Cancer
Attached from the following page is the press release made by BMS for your information.
September 17, 2015 Bristol-Myers Squibb s Opdivo (nivolumab) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Advanced Renal Cell Carcinoma (PRINCETON, NJ, September
Attached from the following page is the press release made by BMS for your information.
June 2, 2015 Phase I/II Opdivo (nivolumab) Trial Shows Bristol-Myers Squibb s PD-1 Immune Checkpoint Inhibitor is First to Demonstrate Anti-Tumor Activity In Patients With Hepatocellular Carcinoma (PRINCETON,
Checkpoint regulators a new class of cancer immunotherapeutics. Dr Oliver Klein Medical Oncologist ONJCC Austin Health
Checkpoint regulators a new class of cancer immunotherapeutics Dr Oliver Klein Medical Oncologist ONJCC Austin Health Cancer...Immunology matters Anti-tumour immune response The participants Dendritc cells
European Commission Approves Expanded Use of Opdivo (nivolumab) to Include Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer
April 13, 2016 European Commission Approves Expanded Use of Opdivo (nivolumab) to Include Previously Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer (PRINCETON, NJ, April 6, 2016) Bristol-Myers
Outcomes Report: Accountability Measures and Quality Improvements
Outcomes Report: Accountability Measures and Quality Improvements The FH Memorial Medical Center s Cancer Committee ensures that patients with cancer are treated according to the nationally accepted measures.
MERCK ONCOLOGY OVERVIEW ASCO 2018 JUNE 4, 2018
MERCK ONCOLOGY OVERVIEW ASCO 218 JUNE 4, 218 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, N.J., USA (the company ) includes forward
Consolidated Financial Results for the Third Quarter of Fiscal Year 2017
Consolidated Financial Results for the Third Quarter of Fiscal Year 2017 1. Revenue Revenue totaled 200.6 billion, which was an increase of 11.7 billion (6.2%) from the corresponding period of the previous
Immunotherapy in the clinic. Lung Cancer. Marga Majem 20 octubre 2017
Immunotherapy in the clinic. Lung Cancer Marga Majem 20 octubre 2017 mmajem@santpau.cat Immunotherapy in the clinic. Lung Cancer Agenda Where we come from? Immunotherapy in Second line Immunotherapy in
ASCO 2018 Investor Meeting
ASCO 2018 Investor Meeting June 4, 2018 1 Forward-Looking Information This presentation contains statements about the Company s future plans and prospects that constitute forward-looking statements for
Keytruda. Keytruda (pembrolizumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.50 Subject: Keytruda Page: 1 of 9 Last Review Date: November 30, 2018 Keytruda Description Keytruda
Immuno-Oncology Clinical Trials Update: Checkpoint Inhibitors Others (not Anti-PD-L1/PD-1) Issue 4 January 2017
Delivering a Competitive Intelligence Advantage Immuno-Oncology Clinical Trials Update: Checkpoint Inhibitors Others (not Anti-PD-L1/PD-1) Issue 4 January 2017 Immuno-Oncology CLINICAL TRIALS UPDATE The
Development of PD-1 and PD-L1 inhibitors as a form of cancer immunotherapy: a comprehensive review of registration trials and future considerations
Gong et al. Journal for ImmunoTherapy of Cancer (2018) 6:8 DOI 10.1186/s40425-018-0316-z REVIEW Development of PD-1 and PD-L1 inhibitors as a form of cancer immunotherapy: a comprehensive review of registration
2 nd line Therapy and Beyond NSCLC. Alan Sandler, M.D. Oregon Health & Science University
2 nd line Therapy and Beyond NSCLC Alan Sandler, M.D. Oregon Health & Science University Treatment options for advanced or metastatic (stage IIIb/IV) NSCLC Suitable for chemotherapy Diagnosis Unsuitable/unwilling
Immune Checkpoint Inhibitors for Lung Cancer William N. William Jr.
Immune Checkpoint Inhibitors for Lung Cancer William N. William Jr. Diretor de Onco-Hematologia Hospital BP, A Beneficência Portuguesa Non-Small Cell Lung Cancer PD-1/PD-L1 Inhibitors in second-line therapy
Merck Oncology Overview. The Development of MSI-H Cancer Therapy. Development of Anti-Cancer Drugs Forum Tokyo, Japan, 18, February 2017
Merck Oncology Overview The Development of MSI-H Cancer Therapy Development of Anti-Cancer Drugs Forum Tokyo, Japan, 18, February 217 Andrew Joe, MD Executive Director, Late Stage Oncology Merck & Co.,
II sessione. Immunoterapia oltre la prima linea. Alessandro Tuzi ASST Sette Laghi, Varese
II sessione Immunoterapia oltre la prima linea Alessandro Tuzi ASST Sette Laghi, Varese AGENDA Immunotherapy post-chemo ( true 2/3L ) Immunotherapy in oncogene addicted NSCLC (yes/no? when?) Immunotherapy
PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN BY PRODUCT
PAGE 175 PART VI: SUMMARY OF THE RISK MANAGEMENT PLAN BY PRODUCT Summary of risk management plan for pembrolizumab This is a summary of the risk management plan (RMP) for pembrolizumab. The RMP details
Challenges in Distinguishing Clinical Signals to Support Development Decisions: Case Studies
Challenges in Distinguishing Clinical Signals to Support Development Decisions: Case Studies David Feltquate MD, PhD Head of Early Clinical Development, Oncology Bristol-Myers Squibb, Princeton, NJ Challenges
Clinical Policy: Nivolumab (Opdivo) Reference Number: ERX.SPA.302 Effective Date:
Clinical Policy: (Opdivo) Reference Number: ERX.SPA.302 Effective Date: 03.01.19 Last Review Date: 02.19 Revision Log See Important Reminder at the end of this policy for important regulatory and legal
6/22/2017 TARGETING THE TARGETS IN 2017 TARGETING THE TARGETS IN 2017
TARGETING THE TARGETS IN 2017 Primary Care Focus Symposium July 1, 2017 Grace Wang MD I do not have any relevant financial relationships to disclose at this time TARGETING THE TARGETS IN 2017 What are
ONO PHARMACEUTICAL CO., LTD. and Bristol-Myers Squibb Announce Strategic Immuno-Oncology Collaboration in Japan, South Korea and Taiwan
ONO PHARMACEUTICAL CO., LTD. and Bristol-Myers Squibb Announce Strategic Immuno-Oncology Collaboration in Japan, South Korea and Taiwan Companies to develop and commercialize Opdivo (nivolumab), ipilimumab,
2016 Updates in Oncology & Malignant Hematology Brendan Curley, DO
2016 Updates in Oncology & Malignant Hematology Brendan Curley, DO Disclosures I received final support from ASCO Conquer Cancer foundation in two Merit Awards and one travel award I am on the speakers
PTAC meeting held on 5 & 6 May (minutes for web publishing)
PTAC meeting held on 5 & 6 May 2016 (minutes for web publishing) PTAC minutes are published in accordance with the Terms of Reference for the Pharmacology and Therapeutics Advisory Committee (PTAC) and
Keytruda. Keytruda (pembrolizumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.50 Subject: Keytruda Page: 1 of 9 Last Review Date: September 20, 2018 Keytruda Description Keytruda
CLINICAL TRIALS ACC. Jul 2016
CLINICAL TRIALS ACC Jul 2016 Glioblastoma BRAIN A071102 A Phase II/III Randomized Trial of Veliparib or Placebo in Combination With Temozolomide in Newly Diagnosed Glioblastoma With MGMT Promoter Hypermethylation
R&D Conference Call. CHUGAI PHARMACEUTICAL CO., LTD. Department Manager of Oncology Lifecycle Management Dept. Megumi Uzu.
R&D Conference Call CHUGAI PHARMACEUTICAL CO., LTD. Department Manager of Oncology Lifecycle Management Dept. Megumi Uzu July 4, 2016 Forward-Looking Statements This presentation may include forward-looking
Overview of 2009 Hong Kong Cancer Statistics
Overview of 2009 Hong Kong Cancer Statistics Cancer Registration in Hong Kong The Hong Kong Cancer Registry has since 1963 been providing population-based cancer data for epidemiological research and healthcare
Índice. Melanoma Cáncer de Pulmón Otros tumores
Índice Melanoma Cáncer de Pulmón Otros tumores Carcinoma de Vejiga Carcinoma de Células Renales Carcinoma de Cabeza y Cuello Carcinomas del tubo digestivo Cáncer de Mama MELANOMA CIRUGÍA CIRUGÍA + INFa
Summary of Research and Writing Activities in Oncology
Summary of Research and Writing Activities in Oncology Carole Alison Chrvala, PhD 919.545.2149 (Work) 919.951.5230 (Mobile) cchrvala@centurylink.net www.healthmattersmedwriting.com 1 Manuscripts, Posters,
Cancer Immunotherapy Patient Forum. for the Treatment of Melanoma, Leukemia, Lymphoma, Lung and Genitourinary Cancers - November 7, 2015
Cancer Immunotherapy Patient Forum for the Treatment of Melanoma, Leukemia, Lymphoma, Lung and Genitourinary Cancers - November 7, 2015 Biomarkers and Patient Selection Julie R. Brahmer, M.D. Director
Role of the Pathologist in Guiding Immuno-oncological Therapies. Scott Rodig MD, PhD
Role of the Pathologist in Guiding Immuno-oncological Therapies Scott Rodig MD, PhD Department of Pathology, Brigham & Women s Hospital Center for Immuno-Oncology, Dana-Farber Cancer Institute Associate
Metastatic NSCLC: Expanding Role of Immunotherapy. Evan W. Alley, MD, PhD Abramson Cancer Center at Penn Presbyterian
Metastatic NSCLC: Expanding Role of Immunotherapy Evan W. Alley, MD, PhD Abramson Cancer Center at Penn Presbyterian Disclosures: No relevant disclosures Please note that some of the studies reported in
July, ArQule, Inc.
July, 2012 Safe Harbor This presentation and other statements by ArQule may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act with respect to clinical
Bristol-Myers Squibb Announces Regulatory Update for Opdivo (nivolumab) in Advanced Melanoma
December 2, 2015 Bristol-Myers Squibb Announces Regulatory Update for Opdivo (nivolumab) in Advanced Melanoma (PRINCETON, NJ, November 27, 2015) Bristol-Myers Squibb Company (NYSE:BMY) announced that the
Merck Oncology Overview ASCO 2017
Merck Oncology Overview ASCO 217 June 5, 217 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, NJ, USA (the company ) includes forward-looking
Merck ASCO 2015 Investor Briefing
Merck ASCO 2015 Investor Briefing Forward-Looking Statement This presentation includes forward-looking statements within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation
Cancer Immunotherapy: Exploring the Role of Novel Agents in Cancer Treatment
Cancer Immunotherapy: Exploring the Role of Novel Agents in Cancer Treatment Patrick Medina, Pharm.D., BCOP Professor The University of Oklahoma College of Medicine Stephenson Cancer Center Faculty Disclosure
Merck Oncology Overview ASCO 2017
Merck Oncology Overview ASCO 217 June 5, 217 Forward-Looking Statement of Merck & Co., Inc., Kenilworth, NJ, USA This presentation of Merck & Co., Inc., Kenilworth, NJ, USA (the company ) includes forward-looking
Opdivo (nivolumab) and Yervoy
June 8, 2016 Opdivo (nivolumab) and Yervoy (ipilimumab) Combination Regimen Shows Clinically Meaningful Responses in First-Line Advanced Non-Small Cell Lung Cancer In Updated Phase 1b CheckMate -012 (PRINCETON,
Immunotherapy and Targeted Therapies: The new face of cancer treatment
Immunotherapy and Targeted Therapies: The new face of cancer treatment Abdulazeez Salawu MBBS, MSc, PhD, MRCP Academic Clinical Lecturer Weston Park Hospital, Sheffield Novel Systemic Anti-cancer Therapies
Keytruda. Keytruda (pembrolizumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.50 Subject: Keytruda Page: 1 of 7 Last Review Date: December 8, 2017 Keytruda Description Keytruda
NSCLC: Terapia medica nella fase avanzata. Paolo Bidoli S.C. Oncologia Medica H S. Gerardo Monza
NSCLC: Terapia medica nella fase avanzata Paolo Bidoli S.C. Oncologia Medica H S. Gerardo Monza First-line Second-line Third-line Not approved CT AND SILENT APPROVAL Docetaxel 1999 Paclitaxel Gemcitabine
Policy. Medical Policy Manual Approved Revised: Do Not Implement until 6/30/2019. Nivolumab
Medical Manual Approved Revised: Do Not Implement until 6/30/2019 Nivolumab NDC CODE(S) 00003-3772-XX Opdivo 40 MG/4ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE)) 00003-3774-XX Opdivo 100 MG/10ML SOLN (B-M SQUIBB
Reflex Testing Guidelines for Immunotherapy in Non-Small Cell Lung Cancer
Reflex Testing Guidelines for Immunotherapy in Non-Small Cell Lung Cancer Jimmy Ruiz, MD Assistant Professor Thoracic Oncology Program Wake Forest Comprehensive Cancer Center Disclosures I have no actual
Policy. Medical Policy Manual Approved Revised: Do Not Implement Until 3/2/19. Nivolumab (Intravenous)
Nivolumab (Intravenous) NDC CODE(S) 00003-3772-XX Opdivo 40 MG/4ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE)) 00003-3774-XX Opdivo 100 MG/10ML SOLN (B-M SQUIBB U.S. (PRIMARY CARE)) 00003-3734-XX Opdivo 240
Keytruda. Keytruda (pembrolizumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.50 Subject: Keytruda Page: 1 of 6 Last Review Date: September 15, 2017 Keytruda Description Keytruda
Use of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies. Eric H. Rubin, MD Merck Research Laboratories
Use of Single-Arm Cohorts/Trials to Demonstrate Clinical Benefit for Breakthrough Therapies Eric H. Rubin, MD Merck Research Laboratories Outline Pembrolizumab P001 study - example of multiple expansion
Bristol-Myers Squibb s Opdivo
May 9, 2016 Bristol-Myers Squibb s Opdivo (nivolumab) Receives Breakthrough Therapy Designation from U.S. Food and Drug Administration for Previously Treated Recurrent or Metastatic Squamous Cell Carcinoma
Opdivo (nivolumab) An overview of Opdivo and why it is authorised in the EU. What is Opdivo and what is it used for?
EMA/852560/2018 EMEA/H/C/003985 An overview of Opdivo and why it is authorised in the EU What is Opdivo and what is it used for? Opdivo is a cancer medicine used to treat the following: melanoma, a type
Epidemiology in Texas 2006 Annual Report. Cancer
Epidemiology in Texas 2006 Annual Report Cancer Epidemiology in Texas 2006 Annual Report Page 94 Cancer Incidence and Mortality in Texas, 2000-2004 The Texas Department of State Health Services Texas Cancer
Nivolumab: esperienze italiane nel carcinoma polmonare avanzato
NSCLC avanzato: quali novità nel 2018? Negrar, 30 Ottobre 2018 Nivolumab: esperienze italiane nel carcinoma polmonare avanzato Francesco Grossi UOC Oncologia Medica Fondazione IRCCS Ca Granda Ospedale
Clinical Policy: Nivolumab (Opdivo) Reference Number: CP.PHAR.121 Effective Date: Last Review Date: Line of Business: Medicaid
Clinical Policy: (Opdivo) Reference Number: CP.PHAR.121 Effective Date: 07.15 Last Review Date: 01.18 Line of Business: Medicaid Revision Log See Important Reminder at the end of this policy for important
Determined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION JUNE 2017
Determined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION JUNE 2017 1 Forward-looking statements disclosure This presentation contains forward-looking
Immunotherapy in Patients with Non-Small Cell Lung Cancer
LIVE WEBINARS Immunotherapy in Patients with Non-Small Cell Lung Cancer Presented by: Leora Horn, MD, MSc Vanderbilt-Ingram Cancer Center July 14, 216 Moderated by Rose K. Joyce NCCN, Conferences and Meetings
Bristol-Myers Squibb s Opdivo
Bristol-Myers Squibb s Opdivo (nivolumab) Receives Expanded FDA Approval in Previously-Treated Metastatic Non-Small Cell Lung Cancer (NSCLC), Offering Improved Survival to More Patients Opdivo is the only
Management Guidelines and Targeted Therapies in Metastatic Non-Small Cell Lung Cancer: An Oncologist s Perspective
Management Guidelines and Targeted Therapies in Metastatic Non-Small Cell Lung Cancer: An Oncologist s Perspective Julie R. Brahmer, M.D. Associate Professor of Oncology The Sidney Kimmel Comprehensive
December 8, Attached from the following page is the press release made by BMS for your information.
December 8, 2016 Encouraging Survival Observed With Opdivo (nivolumab) Plus Yervoy (ipilimumab) With Longer Follow-up in First-line Advanced Non-small Cell Lung Cancer, in Updated Phase 1b CheckMate -012
First Presentation of Two-Year Overall Survival Data for Opdivo (nivolumab) in Combination with Yervoy
April 22, 2016 First Presentation of Two-Year Overall Survival Data for Opdivo (nivolumab) in Combination with Yervoy (ipilimumab) Showed Superior Efficacy Versus Yervoy Alone in Advanced Melanoma (PRINCETON,
Determined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION SEPTEMBER 2017
Determined to realize a future in which people with cancer live longer and better than ever before CORPORATE PRESENTATION SEPTEMBER 2017 1 Forward-looking statements disclosure This presentation contains
Opdivo. Opdivo (nivolumab) Description
Federal Employee Program 1310 G Street, N.W. Washington, D.C. 20005 202.942.1000 Fax 202.942.1125 5.21.53 Subsection: Antineoplastic Agents Original Policy Date: January 16, 2015 Subject: Opdivo Page:
May 20, Attached from the following page is the press release made by BMS for your information.
May 20, 2016 European Commission Approves the First and Only Immuno-Oncology Combination, Opdivo (nivolumab) + Yervoy (ipilimumab) Regimen, for Treatment of Advanced Melanoma (PRINCETON, NJ, May 11, 2016)