2022 World Conference on Lung Cancer (ePosters)-EP08.02-045. Phase 1/2 Study of BLU-945 in Patients With Common Activating EGFR-Mutant Non-Small Cell Lung Cancer

EP08.02-045. Phase 1/2 Study of BLU-945 in Patients With Common Activating EGFR-Mutant Non-Small Cell Lung Cancer

Pdf Summary

The SYMPHONY trial is a phase 1/2 study evaluating the safety and efficacy of BLU-945, a next-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI), in patients with non-small cell lung cancer (NSCLC) harboring common activating EGFR mutations. The study aims to address the unmet medical need for patients with EGFR-mutant NSCLC who develop resistance to currently available therapies.<br /><br />BLU-945 selectively targets the L858R activating mutation, as well as the on-target resistance mutations, T790M and C797S, with high potency while sparing wildtype EGFR. Preclinical studies have demonstrated activity of BLU-945 as monotherapy in both treatment-naïve and osimertinib-resistant EGFR-mutant models.<br /><br />The study design includes a phase 1 dose-escalation portion to determine the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of BLU-945. The study will enroll approximately 30 centers worldwide and includes both monotherapy and combination therapy with osimertinib. The primary endpoints of the study are the MTD, RP2D, safety, and overall response rate (ORR). Secondary endpoints include duration of response, disease control rate, progression-free survival, and overall survival.<br /><br />The study is currently ongoing, and key eligibility criteria include metastatic EGFR-mutant NSCLC, prior treatment with a TKI targeting T790M, and Eastern Cooperative Oncology Group performance status of 0-1.<br /><br />The study aims to provide clinical evidence for the safety and efficacy of BLU-945 in patients with EGFR-mutant NSCLC, including those with resistance mutations. By selectively targeting specific EGFR mutations, BLU-945 has the potential to overcome resistance and improve outcomes for patients with EGFR-mutant NSCLC.

Asset Subtitle

Elaine Shum

Meta Tag

Speaker Elaine Shum

Topic Metastatic Non-small Cell Lung Cancer - Molecular Targeted Treatments

Keywords

SYMPHONY trial

BLU-945

EGFR

NSCLC

activating mutations

resistance

preclinical studies

dose-escalation

MTD

RP2D