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Abstract
Introduction: Attrition in clinical development is widely recognised as a key factor negatively impacting overall R&D efficiency. Gaining an understanding of the reasons for candidate failure may lead to improvements in success rates and return on R&D investment.
Areas covered: This report provides an analysis of reasons for discontinuation of development of 40 drugs dropped from the global oncology pipeline in 2013 – the largest number of terminations reported since this annual analysis began in 2005. The article also provides discussion on the observations in the context of contemporary views of anticancer drug development.
Expert opinion: Twelve drugs (30% of the 2013 discontinuations) failed in Phase III development. None of the pivotal trials investigating these agents incorporated molecular biomarkers for patient stratification. The largest number of drug terminations (20 out of 40) occurred in Phase I development with reasons for termination commonly reported as strategic or undisclosed. Raising the bar in terms of requirements for progression from preclinical development, including the identification of robust pharmacodynamic biomarkers and biomarkers potentially predictive of clinical benefit may lead to an increase in success rates in clinical development and of overall R&D efficiency.
Keywords:
- 4SC-203
- Allovectin-7
- ANX-514
- ASG-5ME
- ASP-9603
- AZD-8330
- BMS-582644
- brivanib alaninate
- cilengitide
- CP-4055
- CS-7017
- E-6201
- efatutazone
- elacytarabine
- EMD-121974
- enzastaurin
- fedratinib
- IMC-RON8
- imgatuzumab
- iniparib
- IPI-504
- KHK-2866
- KW-2450
- litronesib
- LY-2334737
- LY-2523355
- LY-2603618
- LY-3007113
- LY-317615
- MEDI-575
- narnatumab
- OSI-027
- palifosfamide
- parsatuzumab
- PF-4605412
- PR1 vaccine
- PWT-33597
- rabusertib
- retaspimycin
- RG-7112
- RG-7160
- RG-7414
- RG-7420
- SAR-240550
- SAR-302503
- SAR-402674
- sepantronium bromide
- SGN-75
- TAK-441
- TAK-448
- TAK-960
- talactoferrin α
- TAS-266
- tovetumab
- velimogene aliplasmid
- vorsetuzumab mafodotin
- YM-155
- ZIO-201
Declaration of interest
The author has no relevant affiliations or financial involvement with any organisation or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents, received or pending, or royalties.
Notes
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