Precision Medicine Lessons from meta-analyses of 70,253 patients
|
|
- Annice Phillips
- 1 years ago
- Views:
Transcription
1 Precision Medicine Lessons from meta-analyses of 70,253 patients Razelle Kurzrock, MD Senior Deputy Director, Clinical Science Director, Center for Personalized Cancer Therapy and Clinical Trials Office Chief, Division of Hematology/Oncology UCSD Moores Cancer Center
2 Meta-Analyses Conducted 1) Trials leading to FDA approval from trastuzumab (1998) until June ,104 patients; 112 trials 2) Phase II studies published between 2010 through ,149 patients; 570 trials Maria Schwaederle, PharmD
3 Background Treatment selection based on biomarkers reflecting the underlying cancer biology or specific features have brought remarkable advances in oncology. However, the evidence supporting the benefit of a personalized or biomarker-based approach to cancer research and treatment is still a matter of debate. GOAL: compare efficacy outcomes (RR, PFS and OS) and treatment-related mortality between agents developed under a biomarker-based rationale (personalized therapy) versus those that did not.
4 META ANALYSIS STUDY #1 PHASE III TRIALS
5 Impact of a Biomarker-Based Strategy on Oncology Drug Development: A Meta-analysis of Clinical Trials Leading to FDA Approval Denis L. Fontes Jardim, MD 1,2, Maria Schwaederle, PharmD 3, Caimiao Wei, PhD 4, J. Jack Lee, PhD 4, David S. Hong, MD 5, Alexander M. Eggermont, PhD 6,7, Richard L. Schilsky, MD, FACP 7,8, John Mendelsohn, MD 7,9, Vladimir Lazar, PhD 6,7, Razelle Kurzrock, MD 3,7 1 Department of Clinical Medicine, Hemocentro da Unicamp, University of Campinas, Sao Paulo, Brazil 2 Department of Clinical Oncology, Hospital Sirio Libanes, Sao Paulo, Brazil 3 Center for Personalized Cancer Therapy and Division of Hematology and Oncology, University of California, San Diego, CA, USA 4 Department of Biostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX, USA 5 Department of Investigational Cancer Therapeutics (Phase I Clinical Trials Program), The University of Texas MD Anderson Cancer Center, Houston, TX, USA 6 Department of Functional Genomics, Institut Gustave Roussy, University Paris-Sud, Villejuif, France 7 Worldwide Innovative Network For Personalized Cancer Therapy 8 American Society of Clinical Oncology, Alexandria, VA, USA 9 The University of Texas MD Anderson Cancer Center, Houston, USA.
6 Trials leading to FDA approval Search: Newly approved agents from September 1998 (trastuzumab) until June 2013 PubMed or ASCO meetings abstracts. Excluded: Pediatric cancer, supportive care, loco-regional treatment, hormonal therapies, vaccines Endpoints: Response rate (RR), progression-free survival (PFS), overall survival (OS), and toxicity-related deaths.
7 Biomarker-based approach (personalized strategy) definition Treatment met one of the following criteria: Cognate biomarker used to select patients for treatment No biomarker used, but at least 50% of patients are known to harbor the cognate biomarker.
8 Search Results TOTAL 112 trials 57 randomized 55 non-randomized trials Enrolled a total of 38,104 patients
9 Characteristic (%) Median number of patients per experimental arm (range) Trial design Randomized Non-randomized Class agent Cytotoxic Targeted Tumor type Solid Hematologic Route Intravenous Oral Treatment Single agent Combination Population Treatment-naïve Previous treatment Control arm (for randomized trials) Active treatment Placebo/BSC Cross-over allowed (for randomized trials) Yes No Personalized trials; n=44, (%) Non-personalized trials; n=68, (%) P value 152 (7-553) (33-862) (41) 26 (59) 0 44 (100) 20 (45) 24 (55) 14 (32) 30 (68) 39 (89) 5 (11) 13 (30) 31 (70) 13/18 (72) 5/18 (28) 12/18 (67) 6/18 (33) 39 (57) 29 (43) 24 (35) 44 (65) 47 (69) 21 (31) 44 (65) 24 (35) 48 (71) 20 (29) 18 (26) 50 (74) 28/39 (72) 11/39 (28) 11/39 (28) 28/39 (72) 0.12 <
10 Benefit of personalized therapy in randomized registration trials (RR, PFS, and OS) Statistical analysis: meta-analysis of relative response rate ratio (RRR) and hazards ratios (HRs) for PFS and OS for personalized trials versus not (random effect model) RRR: higher likelihood of response with a personalized compared to non-personalized strategy (RRR=3.82 [95%CI: ] vs [95%CI: ], (P=0.03 in meta-regression). HR for PFS: 0.41 (95%CI: ) for personalized compared to 0.59 (95%CI: ) for non-personalized studies, (P<.001 in meta-regression). HR for OS: 0.71 (95%CI: ) for personalized compared to 0.81 (95%CI: ) for non-personalized studies (P=0.07 in meta-regression)
11 Benefits of personalized therapy in all trials (N=112) (RR, PFS, and OS) Stat analysis: random effect meta-analysis for RR; pooled analysis for PFS, and OS for personalized trials versus not (weighted multiple linear regression models) RR: 48% for personalized strategy [95%CI 42-55%] vs. 23% [95%CI 20-27%], P<.001 (also P<.001 after adjustement). PFS: 8.3 months for personalized strategy vs. 5.5 months, P<.001 (P=0.002 after adjustement). OS: 19.3 months for personalized strategy compared to 13.5 months, P=0.01 (P=0.04 after adjustement). Treatment-related mortality was 1.58 percent for personalized versus 1.44 percent for non-personalized trials, which was not statistically different (P=0.74).
12 Summary of results Multivariable analysis: N = 38,104 Randomized trials meta regression Characteristic P-value RRR meta-regression Personalized therapy strategy 0.03 Ctrl arm placebo vs. active drug <0.001 Cross-over allowed <0.001 Progression Free Survival Personalized therapy strategy <0.001 Ctrl arm placebo vs. active drug <0.001 Hematologic tumor vs solid Cross-over allowed <0.001 Overall Survival Personalized therapy strategy 0.07 Hematologic tumor vs solid All trials meta-regression (RR) and weighted pooled multilinear regression (PFS/OS) Characteristic Response rate P-value Personalized therapy strategy <0.001 Chemotherapy-naïve patients <0.001 Hematologic tumor vs solid <0.001 Progression Free Survival Personalized therapy strategy Overall Survival Personalized therapy strategy 0.041
13
14 META ANALYSIS STUDY #2 PHASE II TRIALS
15 Impact of Precision Medicine in Diverse Cancers: a Meta-Analysis of 32,149 Patients in Phase II Clinical Trials Journal of Clinical Oncology, in press Maria Schwaederle, PharmD 1, Melissa Zhao, BS 1, J. Jack Lee, PhD 2, Alexander M. Eggermont, MD, PhD 3,4, Richard L. Schilsky, MD 4,5, John Mendelsohn, MD 4,6, Vladimir Lazar, MD, PhD 3,4, Razelle Kurzrock, MD 1,4 1 Center for Personalized Cancer Therapy and Division of Hematology and Oncology, University of California, La Jolla, U.S. 2 Department of Biostatistics, University of Texas MD Anderson Cancer Center, Houston, TX, USA. 3 Department of Functional Genomics, Institut Gustave Roussy, University Paris-Sud, Villejuif, France. 4 Worldwide Innovative Network for Personalized Cancer Therapy. 5 American Society of Clinical Oncology, Alexandria, VA, USA. 6 The University of Texas MD Anderson Cancer Center, Houston, USA.
16 Meta-Analysis of 32,149 Patients in Phase II Clinical Trials A PubMed search was conducted ( ). Only single agent s arms were included in the analysis. Exclusion criteria: pediatric cancers, supportive care, loco-regional treatments, hormonal therapies, and cellular or vaccine therapy. 570 Phase II studies were included, comprising 32,149 patients (641 single-agent arms). Maria Schwaederle, PharmD
17 Baseline characteristics Personalized or not PERSONALIZED Strategy NON-PERSONALIZED Strategy N of arms N of arms N of P-Value* Characteristics N of patients (%) (%) patients Total studies 112 (100%) (100%) Study Design a Randomized 15 (14%) (18%) 5538 Non-Randomized 95 (86%) (82%) Chemotherapy status Chemo naïve 28 (25%) (19%) 4944 Prior chemotherapy 84 (75%) (81%) Number of patients per arm b (48%) (52%) 6249 > (52%) (48%) Agent Class <0.001 Cytotoxic 1 (1%) (40%) 9647 Targeted 111 (99%) (60%) Administration route <0.001 Oral 94 (84%) (49%) Injection 18 (16%) (51%) FDA or EMA approval No 16 (14%) (21%) 4837 Yes 96 (86%) (79%) Tumor type Solid 88 (79%) (85%) Hematologic 24 (21%) (15%) 3566 Number of treating centers c Single center 32 (29%) (21%) 3299 Multiple centers 79 (71%) (79%) 20609
18 Response rate (%) Months Months Response Rate (%, CI 95%) Median PFS (Months, CI 95%) Median OS (Months, CI 95%) Personalized Not personalized Personalized Not personalized Personalized Not personalized Pooled analysis Meta-analysis
19 Forest Forest plots plots Response Response Rate Rate (RR): (RR): 31% 31% vs. vs. 10.5% 10.5% P-Values univariables P-Values Meta-reg, z= , z=4.6, z=10.7, z= , z= , z= , z=1.9 N/A N/A 0.024, z=2.3 Maria Schwaederle, PharmD
20 Progression-free survival (PFS): 5.9 vs. 2.7 months Personalized Non-Personalized Chemo naïve Prior therapy Solid Hematologic Cytotoxic Targeted Randomized Non-randomized 10 journal IF > 10 journal IF 35 patients/arm > 35 patients/arm Oral Injection Not approved FDA/EMA approved Single center Multiple centers 2 Months 4 Months 6 Months Maria Schwaederle, PharmD 8 Months P-Values univariables P-Values Meta-reg, z=11.1, z=5.3, z=5.6, z=4.9 N/A, z= , z= , z= , z=2.0 N/A
21 Overall survival (OS): 13.7 vs. 8.9 months Personalized Non-Personalized Chemo naïve Prior therapy Solid Hematologic Cytotoxic Targeted 5 Months 10 Months 15 Months 20 Months P-Values univariables P-Values Meta-reg , z=3.8 N/A N/A N/A Randomized Non-randomized 10 journal IF > 10 journal IF 35 patients/arm > 35 patients/arm Oral Injection Not approved FDA/EMA approved Single center Multiple centers Maria Schwaederle, PharmD , z=2.1 N/A 0.005, z=2.8 N/A N/A 0.187, z=1.3
22 Summary of results A personalized strategy was independently associated with higher RRs, longer median PFS and OS (all P ), as well as fewer toxic deaths (P<0.001; 1.5% vs. 2.3%) Both a personalized-direct (alteration was the direct target of the drug tested) and personalized-indirect correlated with better outcomes (all P<0.001). Personalized arms using a genomic alteration (vs. protein overexpression) as biomarker had higher RR, prolonged PFS and OS (all P<0.05). Targeted arms using a personalized strategy had statistically improved outcomes compared to targeted arms that lacked a personalized approach (All P ).
23 CONCLUSIONS Non-personalized targeted arms led to poorer outcomes than cytotoxics arms (All P, except P=0.048 for OS meta-analysis). Worst outcome Best outcome ARMS type Non-personalized targeted RR (%) POOLED Analysis PFS (Mos) OS (Mos) RR (%) Meta-analysis PFS (Mos) OS (Mos) Cytotoxic Personalized targeted
24 THANK YOU for your time and interest Questions??
American Society of Clinical Oncology All rights reserved.
Extended RAS Gene Mutation Testing in Metastatic Colorectal Carcinoma to Predict Response to Anti-EGFR Monoclonal Antibody Therapy: American Society of Clinical Oncology Provisional Clinical Opinion Update
Summary... 2 GENITOURINARY TUMOURS - PROSTATE... 3
ESMO 2016 Congress 7-11 October, 2016 Copenhagen, Denmark Table of Contents Summary... 2 GENITOURINARY TUMOURS - PROSTATE... 3 Custirsen provides no additional survival benefit to cabazitaxel/prednisone
Locoregional treatment Session Oral Abstract Presentation Saulo Brito Silva
Locoregional treatment Session Oral Abstract Presentation Saulo Brito Silva Background Post-operative radiotherapy (PORT) improves disease free and overall suvivallin selected patients with breast cancer
Statistical, clinical and ethical considerations when minimizing confounding for overall survival in cancer immunotherapy trials
Statistical, clinical and ethical considerations when minimizing confounding for overall survival in cancer immunotherapy trials Dominik Heinzmann, PhD Global Development Team Leader HER2 Associate Director
2014 San Antonio Breast Cancer Symposium Review
2014 San Antonio Breast Cancer Symposium Review HER2 Positive Disease 01-10-2015 Elisavet Paplomata, MD Assistant Professor Hematology & Medical Oncology Emory University Winship Cancer Institute S6-01
Immunotherapies in melanoma: regulatory perspective. Jorge Camarero (AEMPS)
Immunotherapies in melanoma: regulatory perspective Jorge Camarero (AEMPS) Challenges for the approval of anti-cancer immunotherapeutic drugs EMA-CDDF joint meeting, London 4-5 February 2016 disclaimers
Page. Objectives: Hormone Therapy Resistance: Challenges and Opportunities. Research Support From Merck
Hormone Therapy Resistance: Challenges and Opportunities Pamela. N. Munster, MD University of California, San Francisco Financial Disclosures Research Support From Merck Objectives: Understanding the current
The case against maintenance rituximab in Follicular lymphoma. Jonathan W. Friedberg M.D., M.M.Sc.
The case against maintenance rituximab in Follicular lymphoma Jonathan W. Friedberg M.D., M.M.Sc. Follicular lymphoma: What are goals of treatment? Change natural history of disease: Decrease transformation
Simulation with copula formula. SSL syysseminaari Toni Sarapohja
Simulation with copula formula SSL syysseminaari 30.10.2014 Toni Sarapohja Initial remarks CRPC regulatory endpoint OS or PFS Typically Phase I/II study include relevant data only for PSA and PSA is considered
trial update clinical
trial update clinical by John W. Mucenski, BS, PharmD, Director of Pharmacy Operations, UPMC Cancer Centers The treatment outcome for patients with relapsed or refractory cervical carcinoma remains dismal.
AACR 2018 Investor Meeting
AACR 218 Investor Meeting April 16, 218 1 Forward-Looking Information This presentation contains statements about the Company s future plans and prospects that constitute forward-looking statements for
12 AISF Special Conference Sorafenib: magnitude of benefit, side effects and stopping rules 9 years after approval
12 AISF Special Conference Sorafenib: magnitude of benefit, side effects and stopping rules 9 years after approval ARMANDO SANTORO Roma 10-6-2016 SORAFENIB APPROVAL 29 OCTOBER 2007 Marketing authorization
against Cancer 55 th HEIDELBERG GRAND ROUNDS Chairs: Prof. Dr. Christof von Kalle Prof. Dr. Dirk Jäger Prof. Dr. Peter Krammer
55 th HEIDELBERG GRAND ROUNDS BIG SHOTS against Cancer Chairs: Prof. Dr. Christof von Kalle Prof. Dr. Dirk Jäger Prof. Dr. Peter Krammer October 25 th, 2016 16.00 18.00 Lecture Hall, DKFZ Communication
Van Cutsem E et al. Proc ASCO 2009;Abstract LBA4509.
Efficacy Results from the ToGA Trial: A Phase III Study of Trastuzumab Added to Standard Chemotherapy in First-Line HER2- Positive Advanced Gastric Cancer Van Cutsem E et al. Proc ASCO 2009;Abstract LBA4509.
Her 2 Positive Advanced Breast Cancer: From Evidence to Practice
Her 2 Positive Advanced Breast Cancer: From Evidence to Practice Sunil Verma MD, FRCP(C) Medical Director, Tom Baker Cancer Center Professor and Head, Department of Oncology Cumming School of Medicine,
Design for Targeted Therapies: Statistical Considerations
Design for Targeted Therapies: Statistical Considerations J. Jack Lee, Ph.D. Department of Biostatistics University of Texas M. D. Anderson Cancer Center Outline Premise General Review of Statistical Designs
Opzioni terapeutiche nel paziente ALK-traslocato
Opzioni terapeutiche nel paziente ALK-traslocato Giulio Metro S.C. Oncologia Medica Ospedale Santa Maria della Misericordia, Azienda Ospedaliera di Perugia Carcinoma del polmone non microcitoma: quali
Design considerations for Phase II trials incorporating biomarkers
Design considerations for Phase II trials incorporating biomarkers Sumithra J. Mandrekar Professor of Biostatistics, Mayo Clinic Pre-Meeting Workshop Enhancing the Design and Conduct of Phase II Studies
Have Results of Recent Randomized Trials Changed the Role of mtor Inhibitors?
Have Results of Recent Randomized Trials Changed the Role of mtor Inhibitors? Bernard Escudier Institut Gustave Roussy Villejuif, France EIKCS Lyon April 2015 What is the current role of mtor inhibitors?
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
Who is the Ideal Candidate for PEG Intron?
Who is the Ideal Candidate for PEG Intron? Sanjiv S. Agarwala, MD Chief, Oncology & Hematology St. Luke s Cancer Center Professor, Temple University School of Medicine Philadelphia, PA, USA Overview Introduction
Neoadjuvant vs. Adjuvant Chemotherapy for Muscle-Invasive Bladder Cancer
Neoadjuvant vs. Adjuvant Chemotherapy for Muscle-Invasive Bladder Cancer Andrew J. Stephenson, MD, FRCSC, FACS Director, Urologic Oncology Associate Professor of Surgery Glickman Urological and Kidney
Which Treatment Approach is Most Appropriate for Primary Therapy of Gastric Cancer: Neoadjuvant Chemotherapy
Which Treatment Approach is Most Appropriate for Primary Therapy of Gastric Cancer: Neoadjuvant Chemotherapy Joseph Chao, M.D. Assistant Clinical Professor Department of Medical Oncology & Therapeutics
Enasidenib Monotherapy is Effective and Well-Tolerated in Patients with Previously Untreated Mutant-IDH2 Acute Myeloid Leukemia
Enasidenib Monotherapy is Effective and Well-Tolerated in Patients with Previously Untreated Mutant-IDH2 Acute Myeloid Leukemia Pollyea DA 1, Tallman MS 2,3, de Botton S 4,5, DiNardo CD 6, Kantarjian HM
ASH 2011: Clinically Relevant Highlights Regarding Venous Thromboembolism and Anticoagulation
ASH 2011: Clinically Relevant Highlights Regarding Venous Thromboembolism and Anticoagulation Stephan Moll Department of Medicine, Division of Hematology-Oncology, University of North Carolina School of
IRESSA (Gefitinib) The Journey. Anne De Bock Portfolio Leader, Oncology/Infection European Regulatory Affairs AstraZeneca
IRESSA (Gefitinib) The Journey Anne De Bock Portfolio Leader, Oncology/Infection European Regulatory Affairs AstraZeneca Overview The Drug The Biomarker and Clinical Trials Sampling Lessons Learned The
Her 2 Positive Metastatic Breast Cancer
Her 2 Positive Metastatic Breast Cancer Alison Jones November 2013 Mrs Hermione Positive (then and now!) Diagnosed 2007 T2 N1 Mo ER ve; Her2 ve Mastectomy ANC; FEC/T Herceptin (12months) August 2010metastatic
Summary BREAST CANCER - Early Stage Breast Cancer... 3
ESMO 2016 Congress 7-11 October, 2016 Copenhagen, Denmark Table of Contents Summary... 2 BREAST CANCER - Early Stage Breast Cancer... 3 Large data analysis reveals similar survival outcomes with sequential
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
WINTHER: GUSTAVE ROUSSY GUSTAVE ROUSSY. NOM DU DOCUMENT / Date
WINTHER Study Jean-Charles Soria, Razelle Kurzrock, Josep Tabernero, Apostolia Tsimberidou, Jordi Rodon, Raanan Berger, Amir Onn, Gerald Batist, Eitan Rubin, Yohann Loriot, Catherine Bresson, Vladimir
Immunotherapy in head and neck cancer and MSI in solid tumors
Immunotherapy in head and neck cancer and MSI in solid tumors Brian Hunis, MD, MBA Associate Medical Director, Memorial Cancer Institute. Hollywood, FL »No disclosures Objectives»Discuss the role of immunology
Targeted Agent and Profiling Utilization Registry
Targeted Agent and Profiling Utilization Registry Richard L. Schilsky, MD, FACP, FASCO Senior Vice President and Chief Medical Officer American Society of Clinical Oncology Disclosure Information Richard
Pacira v. FDA: Summary of Declaration by Lee Jen Wei, PhD Concluding that the Pivotal Hemorrhoidectomy Study for EXPAREL Demonstrated a Treatment
Pacira v. FDA: Summary of Declaration by Lee Jen Wei, PhD Concluding that the Pivotal Hemorrhoidectomy Study for EXPAREL Demonstrated a Treatment Effect for Up To 72 Hours After Surgery Lee Jen Wei, PhD
Neratinib after trastuzumab-based adjuvant therapy in early-stage HER2+ breast cancer: 5-year analysis of the phase III ExteNET trial
Oral presentation #149O Neratinib after trastuzumab-based adjuvant therapy in early-stage HER2+ breast cancer: 5-year analysis of the phase III ExteNET trial Miguel Martin, 1 Frankie A. Holmes, 2 Bent
Cancer du sein métastatique et amélioration de la survie Pr. X. Pivot
Cancer du sein métastatique et amélioration de la survie Pr. X. Pivot Date of preparation: November 2015. EU0250i TTP/PFS Comparaisons First line metastatic breast cancer Monotherapy Docetaxel Chan 1999
Hypo- versus normofractionated radiation therapy of early breast cancer in the randomized DBCG HYPO trial
Hypo- versus normofractionated radiation therapy of early breast cancer in the randomized DBCG HYPO trial BV Offersen 1, HM Nielsen 1, EH Jacobsen 2, MH Nielsen 3, M Krause 4, L Stenbygaard 5, I Mjaaland
Genta Incorporated. A Multiproduct Late-Stage Oncology Company
Genta Incorporated A Multiproduct Late-Stage Oncology Company This presentation may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking
HIGHLIGHTS ESMO 2017 SUPPORTIVE AND PALLIATIVE CARE
HIGHLIGHTS ESMO 2017 SUPPORTIVE AND PALLIATIVE CARE Florian Scotté MD-PhD Hôpital Foch, Suresnes, France esmo.org DISCLOSURE SLIDE Consultant / Advisory Boards / Speaker: Tesaro, Sanofi, Roche, MSD, TEVA,
New Targeted Agents Demonstrate Greater Efficacy and Tolerability in the Treatment of HER2-positive Breast Cancer
New Evidence reports on presentations given at ASCO 2012 New Targeted Agents Demonstrate Greater Efficacy and Tolerability in the Treatment of HER2-positive Breast Cancer Presentations at ASCO 2012 Breast
Perspective on endocrine and chemotherapy agents. Cora N. Sternberg Department of Medical Oncology San Camillo & Forlanini Hospitals Rome, Italy
Perspective on endocrine and chemotherapy agents Cora N. Sternberg Department of Medical Oncology San Camillo & Forlanini Hospitals Rome, Italy Disclosures Dr. Sternberg has received research funding for
Author Block M. Fisch, J. W. Lee, J. Manola, L. Wagner, V. Chang, P. Gilman, K. Lear, L. Baez, C. Cleeland University of Texas M.D. Anderson Cancer Ce
Survey of disease and treatment-related t t related symptoms in outpatients with invasive i cancer of the breast, prostate, lung, or colon/rectum (E2Z02, the SOAPP study, Abst # 9619) Michael J. Fisch,
CONSIDERATIONS IN DEVELOPMENT OF PEMBROLIZUMAB IN MSI-H CANCERS
CONSIDERATIONS IN DEVELOPMENT OF PEMBROLIZUMAB IN MSI-H CANCERS December 2017 Christine K. Gause, Ph.D Executive Director, Biostatistics. 2 Microsatellite Instability-High Cancer - USPI KEYTRUDA is indicated
Immunotherapy in the Adjuvant Setting for Melanoma: What You Need to Know
Immunotherapy in the Adjuvant Setting for Melanoma: What You Need to Know Jeffrey Weber, MD, PhD Laura and Isaac Perlmutter Cancer Center NYU Langone Medical Center New York, New York What Is the Current
OPTIMIZING NONANTHRACYLINES FOR EARLY BREAST CANCER. Stephen E. Jones, M.D. US Oncology Research, McKesson Specialty Health The Woodlands, Tx
OPTIMIZING NONANTHRACYLINES FOR EARLY BREAST CANCER Stephen E. Jones, M.D. US Oncology Research, McKesson Specialty Health The Woodlands, Tx ANTHRACYCLINES AND TAXANES ARE COMMONLY USED USED IN MOST REGIMENS
Clinical: Ipilimumab (MDX-010) Update and Next Steps
Clinical: Ipilimumab (MDX-010) Update and Next Steps Geoffrey M. Nichol, M.D., M.B.A. Senior Vice President, Product Development Medarex, Inc. R&D Day December 9, 2005 Ipilimumab: New Class of Cancer Therapy
Media Release. Basel, 07 December 2017
Media Release Basel, 07 December 2017 Phase III IMpower150 study showed Tecentriq (atezolizumab) and Avastin (bevacizumab) plus chemotherapy reduced the risk of disease worsening or death by 38 percent
Treatment disparities for patients diagnosed with metastatic bladder cancer in California
Treatment disparities for patients diagnosed with metastatic bladder cancer in California Rosemary D. Cress, Dr. PH, Amy Klapheke, MPH Public Health Institute Cancer Registry of Greater California Introduction
Meta-analysis to compare combination therapies: A case study in kidney transplantation
Meta-analysis to compare combination therapies: A case study in kidney transplantation Steffen Witte, Amy Racine, Heinz Schmidli Novartis Pharma AG, Switzerland, Basel, June 2009 Outline Introduction Methods
Individual- and trial-level surrogacy in colorectal cancer
Stat Methods Med Res OnlineFirst, published on February 19, 2008 as doi:10.1177/0962280207081864 SMM081864 2008/2/5 page 1 Statistical Methods in Medical Research 2008; 1 9 Individual- and trial-level
Bendamustine is Effective Therapy in Patients with Rituximab-Refractory, Indolent B-Cell Non-Hodgkin Lymphoma
Bendamustine is Effective Therapy in Patients with Rituximab-Refractory, Indolent B-Cell Non-Hodgkin Lymphoma Kahl BS et al. Cancer 2010;116(1):106-14. Introduction > Bendamustine is a novel alkylating
eastern cooperative oncology group Michael Williams, Fangxin Hong, Brad Kahl, Randy Gascoyne, Lynne Wagner, John Krauss, Sandra Horning
Results of E4402 (RESORT): A Randomized Phase III Study Comparing Two Different Rituximab Dosing Strategies for Low Tumor Burden Indolent B-Cell Lymphoma Michael Williams, Fangxin Hong, Brad Kahl, Randy
BAVARIAN NORDIC BIO DEUTSCHLAND PRESENTATION OCTOBER 2014 CSE/OMX:BAVA, OTC:BVNRY
BAVARIAN NORDIC BIO DEUTSCHLAND PRESENTATION OCTOBER 2014 CSE/OMX:BAVA, OTC:BVNRY This presentation includes "forward-looking statements" that involve risks, uncertainties and other factors, many of which
Developping the next generation of studies in RCC
Developping the next generation of studies in RCC Bernard Escudier Institut Gustave Roussy Villejuif, France Disclosure Information Advisory/Consultancy Role Pfizer, Exelixis, Novartis, BMS, Bayer, Roche,
mcrpc 2014 TRA EVOLUZIONE E RIVOLUZIONE: COME ORIENTARSI NEL LABIRINTO DELLE TERAPIE
mcrpc 2014 TRA EVOLUZIONE E RIVOLUZIONE: COME ORIENTARSI NEL LABIRINTO DELLE TERAPIE IL CARCINOMA PROSTATICO, UNA MALATTIA ETEROGENEA? RAZIONALE E RISULTATI DEL TRATTAMENTO CHEMIOTERAPICO ASSOCIATO ALL
State of the Art: Colorectal Cancer Liver Metastasis Dr. Iain Tan
State of the Art: Colorectal Cancer Liver Metastasis Dr. Iain Tan Consultant GI Medical Oncologist National Cancer Centre Singapore Clinician Scientist, Genome Institute of Singapore OS (%) Overall survival
ADT vs chemo + ADT as initial treatment for advanced prostate cancer
ADT vs chemo + ADT as initial treatment for advanced prostate cancer By Hussein Khaled Prof. Medical Oncology Cairo University Possible Levels of Prostate Cancer At Diagnosis Local-Regional Disease Spread
Targeting the Oncogenic Pathway as Opposed to the Primary Tumor Site: HER2 as an Example
Targeting the Oncogenic Pathway as Opposed to the Primary Tumor Site: HER2 as an Example Dennis J Slamon, MD, PhD Professor of Medicine Chief, Division of Hematology/Oncology; Director of Clinical/Translational
Overall survival with afatinib versus chemotherapy in patients with NSCLC harboring common EGFR
Overall survival with afatinib versus chemotherapy in patients with NSCLC harboring common EGFR mutations: subgroup analyses by race/ethnicity in LUX-Lung 3 and LUX-Lung 6 Yi-Long Wu, 1 Lecia V Sequist,
William J. Gradishar MD
Northwestern University Feinberg School of Medicine Adjuvant Endocrine Therapy For Postmenopausal Women SOBO 2013 William J. Gradishar MD Betsy Bramsen Professor of Breast Oncology Director, Maggie Daley
Maintenance Therapy for Advanced NSCLC: When, What, Why & What s Left After Post-Maintenance Relapse?
Maintenance Therapy for Advanced NSCLC: When, What, Why & What s Left After Post-Maintenance Relapse? Mark A. Socinski, MD Professor of Medicine Multidisciplinary Thoracic Oncology Program Lineberger Comprehensive
Cancer in adolescents and Young Adults
17 th ESO-ESMO Masterclass in Clinical Oncology 24-29 March 2018, Cancer in adolescents and Young Adults Laurence Brugières Gustave Roussy Cancer Center Villejuif, France Cancer in TYA A rare disease in
Disclosures. Immunotherapyin Head & NeckCancer. Actual landscape of systemic treatment in HNSCC. Head andneckcanceris an immunogeneic tumor
Immunotherapyin Head & NeckCancer Disclosures Astra-Zeneca/medimmune: clinical trial BMS: advisory board, clinical trial Merck: advisory board, clinical trial, research funding Carla van Herpen Medical
FDA APPROVES HERCEPTIN FOR THE ADJUVANT TREATMENT OF HER2-POSITIVE NODE-POSITIVE BREAST CANCER
NEWS RELEASE Media Contact: Kimberly Ocampo (650) 467-0679 Investor Contact: Sue Morris (650) 225-6523 Advocacy Contact: Ajanta Horan (650) 467-1741 FDA APPROVES HERCEPTIN FOR THE ADJUVANT TREATMENT OF
Investor Call. May 19, Nasdaq: IMGN
Investor Call May 19, 2017 Nasdaq: IMGN Forward-Looking Statements This presentation includes forward-looking statements based on management's current expectations. These statements include, but are not
GSK Oncology. Axel Hoos, MD, PhD Senior Vice President, Oncology R&D. March 8, 2017
GSK Oncology Axel Hoos, MD, PhD Senior Vice President, Oncology R&D March 8, 217 GSK pipeline Oncology R&D Strategy Maximizing survival through transformational medicines and combinations Cancer Epigenetics
NRG Oncology Lung Cancer Portfolio 2016
NRG Oncology Lung Cancer Portfolio 2016 Roy Decker, MD PhD Yale Cancer Center Walter J Curran, Jr, MD Winship Cancer Institute of Emory University NRG Oncology Lung Cancer Selected Discussion Stage III
Changing demographics of smoking and its effects during therapy
Changing demographics of smoking and its effects during therapy Egbert F. Smit MD PhD. Dept. Pulmonary Diseases, Vrije Universiteit Medical Centre, Amsterdam, The Netherlands Smoking prevalence adults
M D..,., M. M P.. P H., H, F. F A.. A C..S..
Implications of NSABP B-32 and Loco-Regional Therapy Considerations After Neoadjuvant Chemotherapy Terry Mamounas, M.D., M.P.H, F.A.C.S. Professor of Surgery Northeastern Ohio Medical University Medical
Successful practice changing development plans: Rituximab in Burkitt lymphoma
Successful practice changing development plans: Rituximab in Burkitt lymphoma Véronique Minard-Colin, MD, PhD Pediatric and Adolescent Oncology Gustave Roussy, Villejuif, France No disclosure CD20 immunotherapy
HEMATOLOGY AND ONCOLOGY
x THE POWER OF HEMATOLOGY AND ONCOLOGY Experts. Experience. Execution. A Deeper Dive into Hematology and Oncology Medpace supports our sponsors who are advancing new anti-cancer therapies by providing
Edith A. Perez, Ahmad Awada, Joyce O Shaughnessy, Hope Rugo, Chris Twelves, Seock-Ah Im, Carol Zhao, Ute Hoch, Alison L. Hannah, Javier Cortes
BEACON: A Phase 3 Open-label, Randomized, Multicenter Study of Etirinotecan Pegol (EP) versus Treatment of Physician s Choice (TPC) in Patients With Locally Recurrent or Metastatic Breast Cancer Previously
Update on PARP inhibitors: opportunities and challenges in cancer therapy
Update on PARP inhibitors: opportunities and challenges in cancer therapy Vanda Salutari Unità di Ginecologia Oncologica Fondazione Policlinico Universitario A. Gemelli vanda.salutari@policlinicogemelli.it
European Commission approves Roche s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer
Media Release Basel, 21 December 2017 European Commission approves Roche s Alecensa (alectinib) as first-line treatment in ALK-positive lung cancer Alecensa provides a new treatment option for people with
The following slides are provided as presented by the author during the live educa7onal ac7vity and are intended for reference purposes only.
The following slides are provided as presented by the author during the live educa7onal ac7vity and are intended for reference purposes only. If you have any ques7ons, please contact Imedex via email at:
Biomarkers in oncology drug development
Biomarkers in oncology drug development Andrew Stone Stone Biostatistics Ltd EFSPI Biomarkers and Subgroups June 2016 E: andrew@stonebiostatistics.com T: +44 (0) 7919 211836 W: stonebiostatistics.com available
Disease progression after initial platinum-based chemotherapy
Original Article Relevance of Platinum-Sensitivity Status in Relapsed/Refractory Extensive-Stage Small-Cell Lung Cancer in the Modern Era A Patient-Level Analysis of Southwest Oncology Group Trials Primo
A Phase II Study of Atezolizumab With or Without Bevacizumab vs Sunitinib in Untreated Metastatic Renal Cell Carcinoma Patients
A Phase II Study of With or Without Bevacizumab vs in Untreated Metastatic Renal Cell Carcinoma Patients David McDermott, 1 Michael Atkins, 2 Robert Motzer, 3 Brian Rini, 4 Bernard Escudier, 5 Lawrence
African American Men and Prostate Cancer Management Option for Clinical PROSPECT Trial Participation in an Immunotherapy Study
African American Men and Prostate Cancer Management Option for Clinical PROSPECT Trial Participation in an Immunotherapy Study Jennifer Harris, PharmD Medical Science Liaison Bavarian Nordic, Inc. Prostate
Circulating Tumor Cells in non- Metastatic Triple Negative Breast Cancer
Circulating Tumor Cells in non- Metastatic Triple Negative Breast Cancer Carolyn Hall, Ph.D. Department of Surgical Oncology The University of Texas MD Anderson Cancer Center Triple Negative Breast Cancer
Metastatic Renal Cancer Medical Treatment
Metastatic Renal Cancer Medical Treatment Bohuslav Melichar, M.D., Ph.D. Professor and Head Department of Oncology Palacký University Medical School and Teaching Hospital Olomouc, Czech Republic Peculiarities
TOP-LINE DATA FROM THE RANDOMIZED PHASE 2 IMPULSE STUDY IN SMALL-CELL LUNG CANCER (SCLC): IMMUNOTHERAPEUTIC MAINTENANCE TREATMENT WITH LEFITOLIMOD
Abstract #1527O TOP-LINE DATA FROM THE RANDOMIZED PHASE 2 IMPULSE STUDY IN SMALL-CELL LUNG CANCER (SCLC): IMMUNOTHERAPEUTIC MAINTENANCE TREATMENT WITH LEFITOLIMOD M. Thomas, S. Ponce-Aix, A. Navarro Mendivil,
Targeted/Immunotherapy & Molecular Profiling State-of-the-art in Cancer Care
Targeted/Immunotherapy & Molecular Profiling State-of-the-art in Cancer Care Manmeet Ahluwalia, MD, FACP Miller Family Endowed Chair in Neuro-Oncology Director Brain Metastasis Research Program Cleveland
Effective Implementation of Bayesian Adaptive Randomization in Early Phase Clinical Development. Pantelis Vlachos.
Effective Implementation of Bayesian Adaptive Randomization in Early Phase Clinical Development Pantelis Vlachos Cytel Inc, Geneva Acknowledgement Joint work with Giacomo Mordenti, Grünenthal Virginie
Policy. not covered Sipuleucel-T. Considerations Sipuleucel-T. Description Sipuleucel-T. be medically. Sipuleucel-T. covered Q2043.
Cellular Immunotherapy forr Prostate Cancer Policy Number: 8.01.53 Origination: 11/2010 Last Review: 11/2014 Next Review: 11/2015 Policy BCBSKC will provide coverage for cellular immunotherapy for prostate
Roche s Perjeta regimen approved in Europe for use before surgery in early stage aggressive breast cancer
Media Release Basel, 31 July, 2015 Roche s Perjeta regimen approved in Europe for use before surgery in early stage aggressive breast cancer The approval is based on the benefit seen with the Perjeta regimen
Mauricio Camus Appuhn Associate Professor Chief, Department of Surgical Oncology, Pontificia Universidad Católica de Chile
May 18-20, 2017 18 a 20 de Maio / 2017 Castro's Park Hotel Surgery for metastatic breast cancer: the controversy of local surgery for metastatic breast cancer Cirurgia em câncer de mama metastático: a
33 rd Annual J.P. Morgan Healthcare Conference. January 2015
33 rd Annual J.P. Morgan Healthcare Conference January 2015 Forward-looking Statements This presentation contains forward-looking statements, which express the current beliefs and expectations of management.
José Baselga, MD, PhD
i n t e r v i e w José Baselga, MD, PhD Dr Baselga is Physician-in-Chief at Memorial Sloan-Kettering Cancer Center in New York, New York. Tracks 1-15 Track 1 Track 2 Track 3 Track 4 Track 5 Track 6 Track
What Is The Optimal Adjuvant Therapy in Pancreatic Adenoca: Intensified Chemotherapy March 28 th, 2015
What Is The Optimal Adjuvant Therapy in Pancreatic Adenoca: Intensified Chemotherapy March 28 th, 2015 Eileen M. O Reilly, M.D. Associate Director David M. Rubenstein Center Pancreatic Cancer Research
New Evidence reports on presentations given at EHA/ICML Bendamustine in the Treatment of Lymphoproliferative Disorders
New Evidence reports on presentations given at EHA/ICML 2011 Bendamustine in the Treatment of Lymphoproliferative Disorders Report on EHA/ICML 2011 presentations Efficacy and safety of bendamustine plus
Current state of upfront treatment for newly diagnosed advanced ovarian cancer
Current state of upfront treatment for newly diagnosed advanced ovarian cancer Ursula Matulonis, M.D. Associate Professor of Medicine, HMS Program Leader, Medical Gyn Oncology Dana-Farber Cancer Institute
Recent Advances in Lung Cancer: Updates from ASCO 2017
Recent Advances in Lung Cancer: Updates from ASCO 2017 Charu Aggarwal, MD, MPH Assistant Professor of Medicine Division of Hematology-Oncology Abramson Cancer Center University of Pennsylvania 6/15/2017
An update on your support of the Kaplan Cancer Research Fund Swedish Cancer Institute
An update on your support of the Swedish Cancer Institute At Swedish, we re committed to offering our patients the newest, most innovative cancer treatment available. Through your support of the at the
Malignant pleural Mesothelioma: A Year In Review
Malignant pleural Mesothelioma: A Year In Review Rabab Gaafar,MD Prof. Medical Oncology NCI Cairo University National Cancer Institute Conference 2015 ASCO news in Mesothelioma Introduction ASCO news second
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
Current Controversies in Clinical Trials: Perspectives from SCT Fellows. Society for Clinical Trials May 22, 2013
Current Controversies in Clinical Trials: Perspectives from SCT Fellows Society for Clinical Trials May 22, 2013 Session Outline First ~ 60 min Each fellow will provide highlights of their career focusing
METASTATIC PROSTATE CANCER MANAGEMENT K I R U B E L T E F E R A M. D. T R I H E A LT H C A N C E R I N S T I T U T E 0 1 / 3 1 /
METASTATIC PROSTATE CANCER MANAGEMENT K I R U B E L T E F E R A M. D. T R I H E A LT H C A N C E R I N S T I T U T E 0 1 / 3 1 / 2 0 1 8 Prostate Cancer- Statistics Most common cancer in men after a skin
Comparison And Application Of Methods To Address Confounding By Indication In Non- Randomized Clinical Studies
University of Massachusetts Amherst ScholarWorks@UMass Amherst Masters Theses 1911 - February 2014 Dissertations and Theses 2013 Comparison And Application Of Methods To Address Confounding By Indication
Translational Platform for the Development of Targeted Therapeutics
Translational Platform for the Development of Targeted Therapeutics Ondřej Kalous, MD Associate Project Scientist UCLA Translational Oncology Research Laboratories (TORL) Jonsson Comprehensive Cancer Center