MA13.03 BBT-176, a 4th Generation EGFR TKI, for Progressed NSCLC after EGFR TKI Therapy: Updated Report from a Phase 1 Study

Previously we reported interim safety and efficacy results of BBT-176 in patients with metastatic non-small cell lung cancer. BBT-176 is being developed as a non-covalent EGFR TKI with broad-spectrum efficacy covering EGFR C797S. We observed promising early efficacy signals in multiple patients including those harboring EGFR C797S triple mutation, but tolerability was concerned primarily from protracted diarrhea of grade 1 or 2. To improve tolerability and to achieve durable response, we introduced a twice daily dosing schedule after PK/PD simulations.