Activity Number:
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554
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Type:
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Topic Contributed
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Date/Time:
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Wednesday, August 3, 2016 : 10:30 AM to 12:20 PM
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Sponsor:
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Scientific and Public Affairs Advisory Committee
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Abstract #321139
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Title:
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Finding Optimal Combination in Cancer Drug Development: An Evidence Synthesis Approach
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Author(s):
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Sofia Paul* and Fei Ma and Satrajit Roychoudhury
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Companies:
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Novartis and Novartis and Novartis
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Keywords:
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optimal dose ;
combination drug ;
meta-analysis ;
benefit-risk
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Abstract:
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In the current era of Oncology drug development, combining multiple drugs is a primary approach for improving anticancer effects. But there are several challenges in the combination drug development. Phase I trials are mainly designed for establishing the MTD and recommended phase II doses (R2PD) of an anticancer agent. In a typical Oncology development program phase I trials with multiple drug combinations are conducted in parallel to find "optimal" combinations and dose(s) for further development in terms of benefit-risk. But this can be challenging due to small trial size and heterogeneity between trials. We propose a model based meta-analytic approach in benefit-risk framework to synthesize all available data to find "optimal" combination regimen(s) or dose(s) for future development. Developing model for combination regimen needs some additional consideration than single agent as monotonicity in dose toxicity and dose efficacy relationships may not always hold. The proposed approach borrows information across different combination for precise estimation and therefore leads robust decision making. We will use a real life example to illustrate the methodology
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Authors who are presenting talks have a * after their name.