The increasingly impressive clinical results of checkpoint inhibitors have caused a surge in immuno-oncology drug development. Learn more areas of developments as well as solutions to your pain points.

1. CREATING COLLATERAL
IMMUNO-ONCOLOGY DRUG
DEVELOPMENT SOLUTIONS
Succeed in a Competitive Drug
Development Landscape With an
Experienced and Trusted Partner
The increasingly impressive clinical results of checkpoint inhibitors have caused a surge in
immuno-oncology (IO) drug development. A Phase III study revealed PD-1 inhibitor pembrolizumab
could yield a 45% 6-month progression-free survival (PFS) rate in patients with advanced melanoma,
comparing favorably to the previously approved CTLA-4 inhibitor ipilimumab, itself achieving a 27%
6-month PFS rate. An increase in the number of IO clinical trials continues to drive competition for
appropriate patients, high-performing investigators and suitable trial sites.
IMMUNO-ONCOLOGY DRUG DEVELOPMENT PAIN POINTS
► Increasing numbers of trials mean increased competition for eligible patients
–– Currently 101 planned or ongoing industry-sponsored NSCLC studies including
PD-1/PD-L1 inhibitors (November 2017)
► As the field advances, trial protocols are becoming more complicated and demand
greater flexibility
► Increased focus on personalized therapies requires parallel validation of biomarkers
and companion diagnostics (CDx)
► A rapidly changing and crowded marketplace makes it difficult to establish a company’s
optimum position
► International multicenter trials require sophisticated project and data management solutions
FOCUS OF NEW
TREATMENT STRATEGIES
► Combine with current standard of care
► Synergize with another IO agent
► Synergize with targeted therapy
OTHER SIGNIFICANT AREAS OF DEVELOPMENT IN IO
► Monoclonal antibodies
► Emerging checkpoint inhibitors, including IDO1, OX40, CD27, LAG3, CD40 and 4-IBB
► Dendritic cell vaccines
► Chimeric antigen receptor (CAR) T-cell therapies
IMMUNE CHECKPOINT INHIBITORS
40
30
20
NumberofApprovals
Cumulative Number of FDA Approvals by Year
10
0
2011 2012 2013 2014 2015 2016 2017
Durvalumab
Avelumab
Atezolizumab
Pembrolizumab
Ipilimumab +
nivolumab
Nivolumab
Ipilimumab
CUMULATIVE NUMBER OF FDA
APPROVALS BY YEAR

2. CREATING COLLATERAL
IMMUNO-ONCOLOGY DRUG
DEVELOPMENT SOLUTIONS
Overcome Trial Challenges With a Partner
You Can Rely On
Covance has deep medical and scientific expertise in IO approaches, including antibodies, cancer
vaccines, cell-based therapies (e.g. CAR-T), checkpoint inhibitors, gene therapy and oncolytic viruses.
ESTABLISHING A NICHE IN A CROWDED MARKETPLACE
► Access and Strategy team help to navigate complexities in a rapidly changing marketplace
► Conduct market research to understand stakeholder needs and develop value messages
► Generate real-world evidence to communicate product value via Covance Market Access
EFFICIENT PROJECT MANAGEMENT ACROSS LARGE
INTERNATIONAL STUDIES
► Extensive experience running global IO trials (successfully conducted 270 IO trials since 2012)
► Xcellerate®
Trial Management, part of our proprietary informatics suite, integrates all
incoming trial data and supports proactive trial management
VALIDATING BIOMARKERS
► Expertise in biomarker validation and assay feasibility, development and production
► Collectively, LabCorp, Covance Central Laboratories and Covance Translational Biomarker Solutions offer
>3,600 tests across 50 disciplines
► Extensive CDx partnership experience including more than 145 clinical protocols
► Covance Central Laboratories currently supports >1,500 IO trials, including 550 for pembrolizumab (August 2017)
OPTIMIZING TRIAL DESIGN AND CONTROLLING PROTOCOL COMPLEXITY
► Refine eligibility criteria and other protocol parameters prior to finalization by pressure testing
decisions using Xcellerate®
Trial Design
► Expertise in adaptive trial design (including biomarker-guided trial design)
► We have developed an IO training series to ensure site personnel are well-versed in study
protocol requirements and disease assessments
LOCATING ELIGIBLE PATIENTS
► Opt-in patient initiative currently with 150,000 patients
► Clinical trial knowledgebase housing >50% global trial data at any one time – this real-world
data is used to locate target patient populations
► Target sites with prior experience and high recruitment rates using Xcellerate®
Trial Design,
part of our proprietary informatics suite
Learn more about our drug development solutions at www.covance.com
Covance Inc., headquartered in Princeton, NJ, USA is the drug development business of Laboratory
Corporation of America Holdings (LabCorp). COVANCE is registered trademark and themarketing
name for Covance Inc. and its subsidiaries around the world.
The Americas +1.888.COVANCE (+1.888.268.2623) +1.609.452.4440
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