Adam Falconi, BSc, Pharm, Gilberto Lopes, MD, MBA, Jayson L

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Presentation transcript:

Biomarkers and Receptor Targeted Therapies Reduce Clinical Trial Risk in Non–Small- Cell Lung Cancer Adam Falconi, BSc, Pharm, Gilberto Lopes, MD, MBA, Jayson L. Parker, PhD, MBA Journal of Thoracic Oncology Volume 9, Issue 2, Pages 163-169 (February 2014) DOI: 10.1097/JTO.0000000000000075 Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 1 Clinical trial success rates for stage IIIb–IV NSCLC drug-development compounds being tested in various treatment indications are displayed along with industry-wide clinical trial success rate expectations. Transition probability refers to the probability of a compound successfully transitioning from phase I to phase II, phase II to phase III, or phase III to Food and Drug Administration approval. The number above each bar in a clinical trial phase represents the total number of compounds that completed that clinical trial phase and does not include compounds in current active testing in that phase. Cumulative pass rates represent the product of transition probabilities across all three clinical phases and are the values shown above each bar in this section. NSCLC, non–small-cell lung cancer. Journal of Thoracic Oncology 2014 9, 163-169DOI: (10.1097/JTO.0000000000000075) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 2 Clinical trial success rates for stage IIIb–IV NSCLC biomarker targeted and nonbiomarker targeted therapy are displayed along with industry-wide clinical trial success rate expectations. The figure displays parallel analyses for success rates of small-molecule compounds and success rates across all compound types. Transition probability refers to the probability of a compound successfully transitioning from phase I to phase II, phase II to phase III, or phase III to Food and Drug Administration approval. The number above each bar in a clinical trial phase represents the total number of compounds that completed that clinical trial phase and does not include compounds in current active testing in that phase. Cumulative pass rates represent the product of transition probabilities across all three clinical phases and are the values shown above each bar in this section. NSCLC, non–small-cell lung cancer. Journal of Thoracic Oncology 2014 9, 163-169DOI: (10.1097/JTO.0000000000000075) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 3 Clinical trial success rates for stage IIIb–IV NSCLC drug development are displayed along with industry-wide clinical trial success rate expectations for both small-molecule and biologic drugs. Transition probability refers to the probability of a compound successfully transitioning from phase I to phase II, phase II to phase III, or phase III to Food and Drug Administration approval. The number above each bar in a clinical trial phase represents the total number of compounds that completed that clinical trial phase and does not include compounds in current active testing in that phase. Cumulative pass rates represent the product of transition probabilities across all three clinical phases and are the values shown above each bar in this section. NSCLC, non–small-cell lung cancer. Journal of Thoracic Oncology 2014 9, 163-169DOI: (10.1097/JTO.0000000000000075) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 4 Clinical trial success rates for stage IIIb–IV non– small-cell lung cancer drug-development compounds classified by mechanism of action are displayed along with industry-wide clinical trial success rate expectations. Transition probability refers to the probability of a compound successfully transitioning from phase I to phase II, phase II to phase III, or phase III to Food and Drug Administration approval. The number above each bar in a clinical trial phase represents the total number of compounds that completed that clinical trial phase and does not include compounds in current active testing in that phase. Cumulative pass rates represent the product of transition probabilities across all three clinical phases and are the values shown above each bar in this section. Journal of Thoracic Oncology 2014 9, 163-169DOI: (10.1097/JTO.0000000000000075) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions

FIGURE 5 Clinical trial costs for each phase are displayed for each treatment indication. The number above each bar represents the cost in millions of USD for each treatment indication clinical trial phase. The total cost of clinical drug development was obtained by adding the costs of all three clinical trial phases together. NSCLC, non–small-cell lung cancer; USD, U.S. dollars. Journal of Thoracic Oncology 2014 9, 163-169DOI: (10.1097/JTO.0000000000000075) Copyright © 2014 International Association for the Study of Lung Cancer Terms and Conditions