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Session 7: Statistical Challenges and Opportunities in Drug Development with Immunotherapy Oncology Studies
Session Chair(s)
Jeff Maca, PhD
Senior Director, Biostatistics; Advisory Services Analytics
Quintiles, United States
Novel immunotherapies have recently been developed which have provided alternative and often more beneficial treatments for many types of cancers. Key feature of these type of products include initial delay in treatment effect and relative change in time to disease progression measured radiologically not associated with overall survival between treatment arms. However, it is not clear how these delays and relationships will change when these immunotherapies are combined with other targeted or chemotherapy. Careful planning and design considerations of clinical trials are essential to accommodate the changing landscape including treatment for rare cancers. In this session we will discuss some of the statistical challenges in the development of immunotherapies encountered so far and expected in the future.
Learning Objective :
At the conclusion of this session, participants should be able to:
- Understand the statistical considerations for combinations studies
- Describe the issues with a delayed treatment effect often seen in immunotherapy studies
- Design optimal interim analysis plans for immunosuppressive studies
Speaker(s)
Session Co-Chair
Rajeshwari Sridhara, PhD
FDA, United States
Senior Biostatistician Consultant, Oncology Center of Excellence, FDA
Speaker
Lisa Renee Bailey Iacona, PhD, MPH
AstraZeneca Pharmaceuticals LP, United States
Vice President, Oncology Biometrics
Speaker
Sumithra Mandrekar, PhD
Mayo Clinic, United States
Biostatistician
Speaker
Zhenzhen Xu
FDA, United States
Senior Mathematical Statistician, Division of Biostatistics, CBER
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