BridgeBio therapeutics announced on February 13 that it has completed the review of patient dosing data from the fifth cohort of its Phase 1 dose-escalation study for BBT-207, a fourth-generation EGFR tyrosine kinase inhibitor (TKI) for non-small cell lung cancer (NSCLC), during its fifth Safety Monitoring Committee (SMC) meeting.

In the Phase 1 trial, BBT-207 is undergoing stepwise dose escalation to evaluate its safety and efficacy. After each cohort completes dosing, an SMC comprising key investigators evaluates the data.

During the latest SMC meeting, data from six patients in the fifth cohort were analyzed. No serious adverse events related to the drug were observed, and notable clinical outcomes included three cases of partial response (PR) and multiple cases of stable disease (SD), prompting the decision to expand patient enrollment at this dose level to gather additional data.

BridgeBio Therapeutics plans to select two recommended doses from the Phase 1a dose-escalation study and initiate a Phase 1b trial in the second half of this year. Additionally, the company will begin BBT-207 clinical trials at U.S. sites in March to collect multi-ethnic data.

Lee Jung-kyu, CEO of BridgeBio Therapeutics, stated, “The repeated signs of efficacy have heightened our expectations for determining the optimal dose to accelerate BBT-207’s development. With patient recruitment set to begin in the U.S. next month, we are committed to maintaining our leadership in the development of fourth-generation EGFR inhibitors in both domestic and global markets.”