Key Issues |
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1. Exponential increase in number of potential targets/molecules for development |
2. Complex mechanisms of action, which may or may not have synergistic or additive interaction |
3. Need for guidance on dose, regimen and sequence of the combination |
4. Possibility of higher incidence of serious adverse events |
5. Possibility of combination being effective only in hematological tumors or in solid tumors |
6. Time lags in getting early data on dose, efficacy and safety |
7. Lack of clinical data to propose rational and quantitative assessments |
8. Need for strategies to apply combinations with the goal of turning ‘cold’ tumors into ‘hot’ |
9. Competitive pressure and speed of development |