The FDA’s Oncology Center of Excellence has launched Project FrontRunner as a strategic effort to bring promising cancer therapies to patients earlier in their treatment journey. By encouraging randomized trials in first- or second-line metastatic settings rather than relying on single-arm studies in heavily pre-treated populations, the initiative aims to improve both the quality of evidence and patient outcomes.

For sponsors, this shift presents an opportunity to access larger patient populations, accelerate development timelines, and generate more comprehensive safety and efficacy data early in the drug lifecycle. However, it also introduces new operational, clinical, and statistical challenges that must be addressed through thoughtful trial design and regulatory collaboration.

This webinar will cover:

• Overview of Project FrontRunner and its implications for oncology drug development
• Benefits and challenges of conducting first-line randomized trials
• Key statistical considerations
• Role of adaptive designs in accelerating approvals
• Case study: adaptive oncology trial supporting potential accelerated approval

This webinar will explore how innovative trial strategies can lead to faster, more robust pathways to market for oncology therapies.

Speakers

• James Matcham, Vice President, Innovative Statistics
• Pranav Yajnik, Principal Innovative Statistics Consultant