Monotherapy versus Combination Therapy in Oncology Development

This guide discusses the strategic decision-making process in oncology development regarding the choice between monotherapy and combination therapy. It outlines key drivers influencing treatment strategy, including regulatory and clinical risk, cost, speed, and operational load. Monotherapies generally face lower regulatory burdens and demonstrate clearer efficacy, while combination therapies require demonstrating added value and managing increased complexity. The document presents historical benchmarks from Intelligencia AI, revealing that monotherapies tend to have higher success rates in late-phase trials and overall approvals. It also details the challenges faced by combination therapies, such as toxicity and regulatory demands. The guide emphasizes the importance of data-driven decision-making in selecting the most viable treatment path, providing insights into transition rates between trial phases and the implications for investment and market access. Overall, it serves as a resource for executives and clinical strategists in navigating the complexities of oncology therapy development.