All Times EDT
Keywords: Immunotherapy, combination therapy, dose optimization
With decades of progress in medical research and advances in understanding the biology of cancer microenvironment, clinical development of novel cancer drugs including immunotherapies is booming in recent years. In 2018 alone, the FDA approved 19 new cancer drugs and biologics. Checkpoint inhibitors such as CTLA-4 and PD-1/PD-L1 antagonists, and CAR-T therapies have shown exciting results in multiple indications in solid tumors and hematology. The unique mechanisms of action of these novel drugs pose statistical challenges in the accurate evaluation of clinical safety and efficacy, such as late-onset toxicity/efficacy, dose optimization, evaluation of combination agents, pseudo-progression, non-proportional hazards and long-term treatment (cured) effect. To address those challenges, innovative statistical endpoints, designs and analysis methods have been proposed in the literature and applied in cancer immunotherapy trials. In this session, a comprehensive overview of current advancement in statistical methods and designs in immunotherapy will be provided. Experienced speakers from both industry and regulatory agencies will share their insights including common benefits/pitfalls, lessons learned and future recommendations on the statistical components of the protocol and analysis plan in immuno-oncology clinical trials.