Bridge Biotherapeutics will present the phase 1 clinical trial’s result of BBT-176, the fourth-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) drug, at the World Conference on Lung Cancer (WCLC) in Vienna next month.
The conference organizers made public the abstract of the presentation on their website (https://bit.ly/3uv2StQ) on Tuesday.
Professor Lim Sun-min of Yonsei University College of Medicine will discuss the interim clinical data from the phase 1 study of BBT-176. According to Bridge Bio, this study investigates advanced non-small cell lung cancer (NSCLC) patients harboring an EGFR mutation who were previously treated with at least one EFGR TKI.
The presentation will also include the analysis of anti-tumor activity and associated adverse treatment reactions in subjects observed with C797S-containing triple mutations (Del19/T790M/C797S; DTC), which are resistant to third-generation EGFR inhibitors.
The study’s interim results demonstrated a 30.3 percent tumor reduction in patients administered with the 320-mg dose, but only 26.3 percent showed shrinkage among the 480-mg dosing cohort. Subsequently, investigators will explore the recommended phase 2 dose (RP2D) based on the overall safety, efficacy, and tolerability information from the phase 1 study.
The company has sped up the development of BBT-176 since the government selected it as a support task as part of its National Drug Development Project last year.
"We are excited to be the first to present the interim clinical data of BBT-176 to lung cancer experts worldwide," Bridge Bio CEO Lee Jung-kyu said. "In addition to accelerating clinical development in the future, we will try to obtain accelerated FDA approval to present the first treatment options with fourth-generation EGFR inhibitors for terminally ill patients.”