I-SPY 2 Helping To Normalize Adaptive Trial Designs
Publication in NEJM of results from Phase II of master protocol study of breast cancer combinations also helps build support for Bayesian statistics.
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Progress has been made in areas such as lung and breast cancer, but panelists at a recent conference noted there are many efficiencies yet to be realized in drug development and reimbursement.
I-SPY2 study shows promising efficacy for PD-1 inhibitor Keytruda in combination with chemo in high-risk breast cancer – including a tripling of response rate in triple-negative breast cancer – but also raises red flag on immune-mediated adverse events in early-stage patients.
Master protocol for Phase I/II screening trial could make development more efficient, but concerns about regulatory obligations, lack of registrational intent and infrastructure complexity – as well as firms' willingness to share – may be hurdles to participation.