BridgeBio Presents Interim Phase 1 Data of 'BBT-176' at World Conference on Lung Cancer

On the 8th (local time), at the World Conference on Lung Cancer held in Vienna, Austria, Professor Lim Sun-min of the Yonsei Cancer Hospital Lung Cancer Center presented the interim results of the Phase 1 clinical trial of Bridge Biotherapeutics' 4th generation EGFR inhibitor, 'BBT-176'.

[Asia Economy Reporter Chunhee Lee] Bridge Biotherapeutics announced on the 9th that it disclosed positive interim data from the phase 1 dose-escalation trial of 'BBT-176' in an oral presentation on the 8th (local time) at the 2022 World Lung Cancer Conference (IASLC 2022 WCLC), held in person from the 6th to 9th in Vienna, Austria.

The data, first revealed through an oral presentation by Professor Sunmin Lim of Yonsei Cancer Center’s Lung Cancer Center, attracted academic attention by including not only traditional visual criteria-based treatment response analyses such as computed tomography (CT) but also molecular response analyses based on liquid biopsy methods using blood samples, such as circulating tumor DNA (ctDNA) shed from patients' cancer cells.

BBT-176, developed as a fourth-generation epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI), has completed the main dose cohort trial among the ongoing phase 1 and 2 dose-escalation studies and is preparing an additional expansion trial to secure data supporting accelerated approval in advance.

The dose-escalation trial data disclosed in this presentation were compiled as of the end of May. Detailed data on the correlation between radiologic response and molecular response of clinical trial subjects who have continuously received BBT-176 treatment for over 100 days without discontinuation were specifically revealed. Analysis using liquid biopsy showed that patients harboring the triple mutation including C797S targeted by BBT-176 exhibited up to a 53% reduction in EGFR gene detection frequency, and a significant tumor size reduction was confirmed radiologically.

The presentation also mentioned drug safety, the primary efficacy endpoint of phase 1. Clinical results to date confirmed a stable pharmacokinetic profile proportional to the dose, and major adverse reactions observed included low-grade gastrointestinal side effects and skin rash, confirming safety.

Professor Lim stated, “We are verifying clinical cases continuing treatment through the first part of the ongoing phase 1 and 2 dose-escalation trials. We plan to continue clinical trials targeting resistant non-small cell lung cancer patients with no further treatment options, aiming to identify the optimal effective dose and maximize antitumor efficacy and tolerability.”

Jungkyu Lee, CEO of Bridge Biotherapeutics, said, “We are honored to present the successful clinical data of BBT-176 for the first time to lung cancer experts worldwide. We will strive to accelerate clinical development and add innovation to the lung cancer treatment paradigm through new technologies such as companion diagnostics, offering more effective lung cancer treatment options.”

This content was produced with the assistance of AI translation services.