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AACR 2022 | Designing clinical trials for precision oncology

Vivek Subbiah, MD, The University of Texas MD Anderson Cancer Center, Houston, TX, discusses progress made in the advent of precision oncology. Matching tumor mutations with drugs targeting specific oncogenic pathways to provide individualized therapies and to define pre-therapeutic cohort stratification has led to the concept of accelerated conditional approvals. Selpercatinib and pralsetinib are two highly potent, rearranged during transfection (RET)-specific inhibitors that underwent first in human clinical trials circa 2017 and approximately three years later received accelerated, line and tissue agnostic approvals for multiple RET mutations and RET fusions. For selpercatinib, preclinical activity was confirmed before undertaking the LIBRETTO-001 study (NCT03157128) on which FDA approval was based. Patients were enrolled based on the presence of RET fusion-positive or other RET activating mutations in solid tumors. The overall response rate (ORR) for RET-fusion-positive non-small cell lung cancer (NSCLC) was 64% in late-line, and 85% in treatment-naïve patients. Similarly, positive results were recorded in several tumor types. FDA approval of pralsetinib was granted based on efficacy demonstrated in ARROW (NCT03037385) for multi-cohort patients whose tumors had RET alterations. Efficacy measured by ORR for RET fusion-positive NSCLC was 57% in late-line and 70% in treatment-naïve patients. The increased efficacy and accelerated approval times gained from designing clinical trials for precision medicine is likely to become the gold standard in oncology research. This interview took place at the American Association for Cancer Research Annual Meeting in New Orleans, LA.