Pruebas genómicas de recurrencia en cáncer de mama - OncotypeDx y su entornoMauricio Lema
Presentación para el simposio satélite de Amarey en el marco del congreso de los 85 años del Instituto Nacional de Cancerología, Hotel Hyatt, 29.08.2019, Bogotá
Pruebas genómicas de recurrencia en cáncer de mama - OncotypeDx y su entornoMauricio Lema
Presentación para el simposio satélite de Amarey en el marco del congreso de los 85 años del Instituto Nacional de Cancerología, Hotel Hyatt, 29.08.2019, Bogotá
Costo efficacia della terapia con sorafenib nel trattamento dell’HCC - Gastro...Gastrolearning
Gastrolearning III lezione
Costo efficacia della terapia con sorafenib nel trattamento dell’HCC - Prof. C. Cammà (Università di Palermo)
www.gastrolearning.it
Despite remarkable progress in the treatment of HER2+ breast cancer, management of this patient population continues to remain a challenge, both in the adjuvant and metastatic settings. An enhanced understanding of the treatment options available for HER2+ breast cancer patients in different settings is imperative to improving patient survival and quality of life. This activity consisting of didactic presentations and case illustrations will address treatment choices for HER2+ patients after trastuzumab progression; proposed mechanisms of resistance; combination treatment approaches; the role of anthracyclines and HER2-targeted agents in this population; and novel targeted agents under investigation, including mTOR inhibitors, antiangiogenic inhibitors, and HER2-targeted therapies.
More information:
http://imeronline.com/867dsd
Review a downloadable slide deck by Kathy D. Miller, MD, covering the most clinically relevant new data reported from Future Directions in the Treatment of Patients With HER2+ Breast Cancer: What Community Oncologists Need to Know.
Target Audience
This activity is designed to meet the educational needs of oncologists and other healthcare professionals involved in cancer care.
Slide Deck Disclaimer
This slide deck in its original and unaltered format is for educational purposes and is current as of September 2012. All materials contained herein reflect the views of the faculty, and not those of IMER, the CME provider, or the commercial supporter. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. Readers should not rely on this information as a substitute for professional medical advice, diagnosis, or treatment. The use of any information provided is solely at your own risk, and readers should verify the prescribing information and all data before treating patients or employing any therapeutic products described in this educational activity.
Usage Rights
This slide deck is provided for educational purposes and individual slides may be used for personal, non-commercial presentations only if the content and references remain unchanged. No part of this slide deck may be published in print or electronically as a promotional or certified educational activity without prior written permission from IMER. Additional terms may apply. See Terms of Service on IMERonline.com for details.
More information:
http://imeronline.com/867dsd
Audio and slides for this presentation are available on YouTube: http://youtu.be/e_KVYJX2GTs
Have you ever wondered about your genetic predisposition to cancer? How cancer evolves in families? Or how cancer cells differ from normal cells in your body? Join Judy Garber, MD, MPH, director of the Center for Cancer Genetics and Prevention at Dana-Farber Cancer Institute, as she explores the basics of cancer genetics, DNA mutations, genetic screening, management, and more.
Costo efficacia della terapia con sorafenib nel trattamento dell’HCC - Gastro...Gastrolearning
Gastrolearning III lezione
Costo efficacia della terapia con sorafenib nel trattamento dell’HCC - Prof. C. Cammà (Università di Palermo)
www.gastrolearning.it
Despite remarkable progress in the treatment of HER2+ breast cancer, management of this patient population continues to remain a challenge, both in the adjuvant and metastatic settings. An enhanced understanding of the treatment options available for HER2+ breast cancer patients in different settings is imperative to improving patient survival and quality of life. This activity consisting of didactic presentations and case illustrations will address treatment choices for HER2+ patients after trastuzumab progression; proposed mechanisms of resistance; combination treatment approaches; the role of anthracyclines and HER2-targeted agents in this population; and novel targeted agents under investigation, including mTOR inhibitors, antiangiogenic inhibitors, and HER2-targeted therapies.
More information:
http://imeronline.com/867dsd
Review a downloadable slide deck by Kathy D. Miller, MD, covering the most clinically relevant new data reported from Future Directions in the Treatment of Patients With HER2+ Breast Cancer: What Community Oncologists Need to Know.
Target Audience
This activity is designed to meet the educational needs of oncologists and other healthcare professionals involved in cancer care.
Slide Deck Disclaimer
This slide deck in its original and unaltered format is for educational purposes and is current as of September 2012. All materials contained herein reflect the views of the faculty, and not those of IMER, the CME provider, or the commercial supporter. These materials may discuss therapeutic products that have not been approved by the US Food and Drug Administration and off-label uses of approved products. Readers should not rely on this information as a substitute for professional medical advice, diagnosis, or treatment. The use of any information provided is solely at your own risk, and readers should verify the prescribing information and all data before treating patients or employing any therapeutic products described in this educational activity.
Usage Rights
This slide deck is provided for educational purposes and individual slides may be used for personal, non-commercial presentations only if the content and references remain unchanged. No part of this slide deck may be published in print or electronically as a promotional or certified educational activity without prior written permission from IMER. Additional terms may apply. See Terms of Service on IMERonline.com for details.
More information:
http://imeronline.com/867dsd
Audio and slides for this presentation are available on YouTube: http://youtu.be/e_KVYJX2GTs
Have you ever wondered about your genetic predisposition to cancer? How cancer evolves in families? Or how cancer cells differ from normal cells in your body? Join Judy Garber, MD, MPH, director of the Center for Cancer Genetics and Prevention at Dana-Farber Cancer Institute, as she explores the basics of cancer genetics, DNA mutations, genetic screening, management, and more.
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
micro teaching on communication m.sc nursing.pdfAnurag Sharma
Microteaching is a unique model of practice teaching. It is a viable instrument for the. desired change in the teaching behavior or the behavior potential which, in specified types of real. classroom situations, tends to facilitate the achievement of specified types of objectives.
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
263778731218 Abortion Clinic /Pills In Harare ,sisternakatoto
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CDSCO and Phamacovigilance {Regulatory body in India}NEHA GUPTA
The Central Drugs Standard Control Organization (CDSCO) is India's national regulatory body for pharmaceuticals and medical devices. Operating under the Directorate General of Health Services, Ministry of Health & Family Welfare, Government of India, the CDSCO is responsible for approving new drugs, conducting clinical trials, setting standards for drugs, controlling the quality of imported drugs, and coordinating the activities of State Drug Control Organizations by providing expert advice.
Pharmacovigilance, on the other hand, is the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. The primary aim of pharmacovigilance is to ensure the safety and efficacy of medicines, thereby protecting public health.
In India, pharmacovigilance activities are monitored by the Pharmacovigilance Programme of India (PvPI), which works closely with CDSCO to collect, analyze, and act upon data regarding adverse drug reactions (ADRs). Together, they play a critical role in ensuring that the benefits of drugs outweigh their risks, maintaining high standards of patient safety, and promoting the rational use of medicines.
Flu Vaccine Alert in Bangalore Karnatakaaddon Scans
As flu season approaches, health officials in Bangalore, Karnataka, are urging residents to get their flu vaccinations. The seasonal flu, while common, can lead to severe health complications, particularly for vulnerable populations such as young children, the elderly, and those with underlying health conditions.
Dr. Vidisha Kumari, a leading epidemiologist in Bangalore, emphasizes the importance of getting vaccinated. "The flu vaccine is our best defense against the influenza virus. It not only protects individuals but also helps prevent the spread of the virus in our communities," he says.
This year, the flu season is expected to coincide with a potential increase in other respiratory illnesses. The Karnataka Health Department has launched an awareness campaign highlighting the significance of flu vaccinations. They have set up multiple vaccination centers across Bangalore, making it convenient for residents to receive their shots.
To encourage widespread vaccination, the government is also collaborating with local schools, workplaces, and community centers to facilitate vaccination drives. Special attention is being given to ensuring that the vaccine is accessible to all, including marginalized communities who may have limited access to healthcare.
Residents are reminded that the flu vaccine is safe and effective. Common side effects are mild and may include soreness at the injection site, mild fever, or muscle aches. These side effects are generally short-lived and far less severe than the flu itself.
Healthcare providers are also stressing the importance of continuing COVID-19 precautions. Wearing masks, practicing good hand hygiene, and maintaining social distancing are still crucial, especially in crowded places.
Protect yourself and your loved ones by getting vaccinated. Together, we can help keep Bangalore healthy and safe this flu season. For more information on vaccination centers and schedules, residents can visit the Karnataka Health Department’s official website or follow their social media pages.
Stay informed, stay safe, and get your flu shot today!
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Tom Selleck Health: A Comprehensive Look at the Iconic Actor’s Wellness Journeygreendigital
Tom Selleck, an enduring figure in Hollywood. has captivated audiences for decades with his rugged charm, iconic moustache. and memorable roles in television and film. From his breakout role as Thomas Magnum in Magnum P.I. to his current portrayal of Frank Reagan in Blue Bloods. Selleck's career has spanned over 50 years. But beyond his professional achievements. fans have often been curious about Tom Selleck Health. especially as he has aged in the public eye.
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Introduction
Many have been interested in Tom Selleck health. not only because of his enduring presence on screen but also because of the challenges. and lifestyle choices he has faced and made over the years. This article delves into the various aspects of Tom Selleck health. exploring his fitness regimen, diet, mental health. and the challenges he has encountered as he ages. We'll look at how he maintains his well-being. the health issues he has faced, and his approach to ageing .
Early Life and Career
Childhood and Athletic Beginnings
Tom Selleck was born on January 29, 1945, in Detroit, Michigan, and grew up in Sherman Oaks, California. From an early age, he was involved in sports, particularly basketball. which played a significant role in his physical development. His athletic pursuits continued into college. where he attended the University of Southern California (USC) on a basketball scholarship. This early involvement in sports laid a strong foundation for his physical health and disciplined lifestyle.
Transition to Acting
Selleck's transition from an athlete to an actor came with its physical demands. His first significant role in "Magnum P.I." required him to perform various stunts and maintain a fit appearance. This role, which he played from 1980 to 1988. necessitated a rigorous fitness routine to meet the show's demands. setting the stage for his long-term commitment to health and wellness.
Fitness Regimen
Workout Routine
Tom Selleck health and fitness regimen has evolved. adapting to his changing roles and age. During his "Magnum, P.I." days. Selleck's workouts were intense and focused on building and maintaining muscle mass. His routine included weightlifting, cardiovascular exercises. and specific training for the stunts he performed on the show.
Selleck adjusted his fitness routine as he aged to suit his body's needs. Today, his workouts focus on maintaining flexibility, strength, and cardiovascular health. He incorporates low-impact exercises such as swimming, walking, and light weightlifting. This balanced approach helps him stay fit without putting undue strain on his joints and muscles.
Importance of Flexibility and Mobility
In recent years, Selleck has emphasized the importance of flexibility and mobility in his fitness regimen. Understanding the natural decline in muscle mass and joint flexibility with age. he includes stretching and yoga in his routine. These practices help prevent injuries, improve posture, and maintain mobilit
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
2. Forward Looking Statement
This communication contains "forward-looking" statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements other than statements of
historical fact are statements that could be forward-looking statements. You can identify
these forward looking statements through our use of words such as “may,” “will,” “can,”
forward-looking may, will, can,
“anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,”
“seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,”
“target,” “potential” and other similar words and expressions of the future. These forward-
looking statements are subject to risks and uncertainties that may cause actual future
experience and results to differ materially from those discussed in these forward-looking
statements. Important factors that might cause such a difference include, but are not
limited to, the timing, cost and uncertainty of obtaining regulatory approvals for product
ca d dates; our ability develop and commercialize p oducts be o e co pet to s t at are
candidates; ou ab ty to de e op a d co e c a e products before competitors that a e
superior to the alternatives developed by such competitors; the validity of our patents and
our ability to avoid intellectual property litigation, which can be costly and divert
management time and attention; and the other factors listed under “Risk Factors” in our
filings with the SEC, including Forms 10-K, 10-Q and 8-K.
g , g , Q
Celldex does not undertake any obligation to release publicly any revisions to such
forward-looking statement to reflect events or circumstances after the date hereof or to
reflect the occurrence of unanticipated events.
2
3. The Target: GPNMB
Patients with High GPNMB-Expressing
Tumors Have Significantly Shorter
An internalizable Metastasis-Free and Overall Survival
glycoprotein expressed in
sis-Free Surviv (%)
100
~40-75% of breast cancers, ,
val
80
as well as other tumor types 60 P = 0.032
Promotes the migration, 40
low GPNMB (n=98)
invasion, and metastasis of
f
Metastas
20 intermediate GPNMB (n=98)
high GPNMB (n=99)
breast cancer 0
0 5 10 15 20
Time (Years)
Highly expressed in triple- 100
negative breast cancers
Overall Survival (%)
80
where it is associated with 60
P = 0.007
increased risk of recurrence
i d i k f 40
low GPNMB (n=98)
20 intermediate GPNMB (n=98)
high GPNMB (n=99)
0
0 5 10 15 20
Time (Years)
Rose A, et al. Clin. Cancer Res. 2010
3
4. CDX-011: First-in-class, Next Generation
Therapeutic Antibody
p y
▪ Antibody drug conjugate designed to release MMAE
upon internalization into GPNMB-expressing tumor cells
Celldex proprietary target and antibody
Toxin and linker licensed from Seattle Genetics
• Same technology as AdcetrisTM
O H O HO
N
mAb val-cit-HN O N N N
N
O OCH3 O H
OCH3 O
valine-citrulline enzyme-cleavable linker
CR011: fully-human IgG2 targeting GPNMB MMAE: dolastatin-like tubulin inhibitor
4
5. CDX-011: Consistent Clinical Experience
▪ Phase 1/2 study in patients with heavily pre-treated metastatic
melanoma (n=117), not selected for GPNMB expression
CDX-011 well tolerated; Phase 2 dose defined at 1.88 mg/kg
Exploratory analysis showed enrichment for tumor regression in
patients with significant tumor GPNMB expression
▪ Phase 1/2 trial in advanced, heavily pre-treated breast cancer
pre treated
patients (n=42), not selected for GPNMB expression
Encouraging activity in patients with triple-negative disease
(
(ER/PR/HER2 negative) where treatment options are limited
g ) p
Data suggest that patients with significant GPNMB expression
receive greatest benefit from CDX-011
▪ Preliminary results from randomized, Phase 2b EMERGE study
again show very encouraging activity in patients with triple negative
disease and in patients with significant GPNMB expression
5
6. EMERGE: Phase 2b Randomized Study in
Advanced Breast Cancer
Advanced, GPNMB-expressing breast cancer patients
refractory/resistant to approved therapies (targeted n=120)
Study designed to examine whether anti-cancer activity of CDX-011
is dependent upon distribution/intensity of GPNMB expression
Endpoints: overall response rate [p
p p [primary], progression-free
y], p g
survival, duration of response, safety, PK/PD
Study initiated Sep 2010; enrollment completed Dec 2011
• Locally advanced or metastatic, “Investigator’s Choice”
GPNMB+ breast cancer PD
• Refractory/resistant to approved
therapies (including taxane,
anthracycline, capecitabine; and Option to cross-over t
O ti t to
Randomization CDX-011 upon PD
trastuzumab, lapatinib if HER2+) (2:1) confirmed by independent
• 2-7 prior lines of cytotoxic central review
chemotherapy for advanced
disease
• Progression within 6 months of PD
CDX-011
last regimen
6
7. EMERGE: Tissue Screening for GPNMB Expression
EMERGE patients were selected for GPNMB expression using
validated, centralized IHC method
Generally historical samples from prior resections (primary or metastatic)
Of 338 screened patients, 99% were considered eligible
p , % g
(≥ 5% of tumor or stroma cells expressing GPNMB)
GPNMB Expression in Breast Cancer
GPNMB staining of
g 100%
breast cancer tumor cells 90%
% of Screened Patients
80%
70%
60%
d 50%
40%
30%
20%
o
10%
0%
Any ≥10% ≥25% Any ≥10% ≥25%
GPNMB+ Tumor cells GPNMB+ Stroma cells
7
8. EMERGE: Baseline Characteristics
All Treated Patients
CDX-011 Investigator’s
(N=81) Choice (N=41)
Mean Age [Years (SD)] 56.4 (10.4)
56 4 (10 4) 55.8 (10.0)
55 8 (10 0)
Breast Cancer Stage [n (%)] III 2 (2%) 0
IV 79 (98%) 41 (100%)
Visceral disease (Liver or Lung) [n (%)] 67 (83%) 33 (80%)
Mean Duration of Metastatic or
4.0 (3.5) 3.0 (3.1)
Locally Advanced Disease [Years (SD)]
PR P iti [ (%)] *
Positive [n 31 (38%) 20 (49%)
ER Positive [n (%)] 48 (59%) 26 (63%)
HER2 Positive [n (%)] ** 9 (11%) 9 (22%)
Triple Negative [n (%)] 27 (33%) 11 (27%)
Prior Anticancer Regimens [Median (Range)] 6 (2-10) 5 (2-11)
SD = standard deviation; PR = progesterone receptor; ER = estrogen receptor; HER2 = human epidermal growth factor
receptor 2; IC = Investigator’s Choice
Investigator s
* PR status is unknown for 2 CDX-011 patients.
** HER2 status is unknown for 3 CDX-011 and 1 IC patient.
8
10. EMERGE: Activity of CDX-011 is Greatest in Patients
with Triple Negative and GPNMB-Expressing Disease
All Patients Triple Negative High GPNMB Triple Negative
Expression and
(≥25% Tumor High GPNMB
Cells)
C ll ) Expression
CDX-011 IC CDX-011 IC CDX-011 IC CDX-011 IC
(n=81) (n=36) (n=24) (n=9) (n=25) (n=8) (n=11) (n=3)
Partial Response 19% 14% 21% 0% 32% 13% 36% 0%
Confirmed PR 12% 8% 8% 0% 16% 13% 9% 0%
Disease Control Rate 59% 50% 71% 33% 64% 38% 82% 33%
Any Tumor Shrinkage 50% 46% 54% 33% 57% 38% 64% 33%
Responses per RECIST 1.1; IC = Investigator’s Choice; PR = Partial Response; CDX-011 arm includes 15 patients who
crossed over to receive CDX-011 treatment after progression on IC.
p g
Analysis of best response excludes patients who discontinued from study without evaluable post-baseline radiographic
imaging (n=15 for CDX-011 arm; n=5 for IC arm).
Analysis of tumor shrinkage excludes additional patients without evaluable post-baseline imaging of all target lesions (n=5 for
CDX-011 arm; n=1 for IC arm).
10
11. EMERGE: Correlation of Response and GPNMB
Expression
p
CDX-011 Investigator’s Choice
35%
ponse*
30%
tients with Partial Resp
25%
20%
P
15%
10%
% Pat
5%
0%
Low GPNMB High GPNMB
g Low GPNMB High GPNMB
g
Expression Expression Expression Expression
Tumor Cells Expressing GPNMB
Low G
GPNMB expression is defined as expression in <25% of tumor cells, while high GPNMB
f % f G
expression is defined as expression in ≥25% of tumor cells.
* Including confirmed and unconfirmed PR
11
12. EMERGE: Triple-Negative Patients
Correlation of Response and GPNMB Expression
p p
CDX-011 Investigator’s Choice
40%
nse*
35%
% Patien with Partial Respon
30%
25%
20%
15%
nts
10%
5%
0%
Low GPNMB High GPNMB
g Low GPNMB High GPNMB
g
Expression Expression Expression Expression
Tumor Cells Expressing GPNMB
Low G
GPNMB expression is defined as expression in <25% of tumor cells, while high GPNMB
f % f G
expression is defined as expression in ≥25% of tumor cells.
* Including confirmed and unconfirmed PR
12
13. EMERGE: Early Progression-Free Survival in Triple
Negative and GPNMB-Expressing Breast Cancer
Triple High GPNMB Expression Triple Negative and
Negative (≥25% of Tumor Cells) High GPNMB Expression
Progression-Free Survival Probability
CDX-011 CDX-011 CDX-011
IC IC IC
P = 0 4071
0.4071 P = 0 0996
0.0996 P = 0.0032
0 0032
Months Months Months
13
14. EMERGE: Current Standard of Care Therapies Produce
Low Response Rate in GPNMB+ Patients
Over half (54%) of the patients randomized to Investigator’s Choice arm in
EMERGE received Halaven® or Ixempra®
Prior Studies EMERGE Experience
in Treatment- All GPNMB
Refractory Patients expression in
Breast Cancer ≥ 25% of
Tumor Cells
®
Halaven (Eribulin)
Partial Response 0% (0/13) 0% (0/6)
Confirmed PR 12-13%1 0% (0/13) 0% (0/6)
Ixempra® (Ixabepilone)
Partial Response 14% (1/7) 0% (0/1)
Confirmed PR 11-18%2 0% (0/7) 0% (0/1)
PR = Partial Response
1. Cortes J, et al. Lancet. 2011
2. Perez, et. al. JCO, 2007
14
15. Preliminary EMERGE Results Consistent with Previous
Data in Similar Population
Promising activity in triple-negative breast cancer (TNBC), where
treatment options are limited
CDX 011
CDX-011 response rate of 21% in TNBC compared to 0% for
Investigator’s Choice (IC) therapy
Significant tumor expression of GPNMB associated with greater
activity
CDX-011 response rate of 32% compared to 13% for IC
High GPNMB expression seen in 39% of patients with TNBC; in
these patients, CDX-011 response rate of 36% and progression-free
th ti t CDX 011 t f d i f
survival advantage of 130% (p=0.0032)
Celldex will explore possible registrational paths in these patients
with significant unmet medical need
Additional Phase 2 development possible in other GPNMB-
expressing tumor types (
p g yp (melanoma, lymphoma, lung cancer)
, y p , g )
15