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Published on: March 20, 2021
Impact of biomarker usage on oncology drug development
K Hayashi1, S Masuda, H Kimura
1Pharmaco-Business Innovation Laboratory, Graduate School of Pharmaceutical Sciences, The University of Tokyo, Tokyo, Japan. pbi_info@mol.f.u-tokyo.ac.jp
What Is Known And Objective:
The increasing cost of drug research and development and the decreasing number of new drugs being launched are serious issues for pharmaceutical companies. Biomarkers for predicting drug effectiveness are regarded as useful tools for combating these trends. However, the extent to which these biomarkers actually help in improving drug development is unclear. Here, we investigated the efficiency of biomarker usage in oncology drug development by focusing on stratification markers.
Methods:
Anti-tumour agents for which clinical studies were initiated between 1998 and 2009 were identified using commercially available data sources, and clinical trials registered in ClinicalTrials.gov were examined to identify the use of stratification marker. Phase transition probability for each clinical phase was calculated and analysed along with various other factors that may affect the efficiency of the development process.
Results And Discussion:
Of 908 anti-tumour agents identified, 121 (13·3%) utilized stratification markers in their clinical studies. Phase I, II and III transition probabilities for all agents were 76·4%, 50·8% and 58·5%, respectively. Corresponding Phase I, II and III transition probabilities of agents developed with stratification markers of 90·4%, 69·0% and 85·0%, respectively, were significantly higher than those for agents without stratification markers. Orphan designation positively affected phase transition probabilities of agents without stratification markers in all phases, while it did not affect transition probabilities of agents with stratification markers, except for Phase II. This shows that stratification markers help improve the probability of success in the development of agents without orphan designation.
What Is New And Conclusion:
Stratification markers contribute to improving the efficiency of development of anti-cancer drugs. The majority of non-orphan drugs are still being developed without stratification markers. Finding reliable stratification markers for all drugs should improve the success rates in drug development.
Insights
Stratification markers significantly improve oncology drug development success rates, particularly for non-orphan drugs. Utilizing these predictive biomarkers enhances clinical trial efficiency and drug approval probability.
Area of Science:
- Oncology
- Drug Development
- Biomarker Research
Background:
- Rising drug development costs and declining new drug launches pose challenges for pharmaceutical companies.
- Biomarkers are explored for predicting drug efficacy, but their impact on development efficiency remains unclear.
Purpose of the Study:
- To investigate the efficiency of biomarker usage in oncology drug development.
- To focus on the role of stratification markers in improving anti-cancer drug development success rates.
Main Methods:
- Analysis of anti-cancer agents with clinical studies initiated between 1998 and 2009.
- Examination of clinical trials for stratification marker utilization and calculation of phase transition probabilities.
Main Results:
- 13.3% of 908 anti-cancer agents utilized stratification markers.
- Agents with stratification markers showed significantly higher Phase I, II, and III transition probabilities (90.4%, 69.0%, 85.0%) compared to those without.
- Orphan designation impacted transition probabilities differently for agents with and without stratification markers.
Conclusions:
- Stratification markers enhance the efficiency of anti-cancer drug development, especially for non-orphan drugs.
- Widespread adoption of reliable stratification markers could significantly improve drug development success rates.
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