2022 World Conference on Lung Cancer (ePosters)-EP08.02-018. Phase 1/2 Study of BLU-451, a Small Molecule Inhibitor of EGFR, in EGFR Exon 20 Insertion-Mutant Incurable Advanced Cancers

EP08.02-018. Phase 1/2 Study of BLU-451, a Small Molecule Inhibitor of EGFR, in EGFR Exon 20 Insertion-Mutant Incurable Advanced Cancers

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The CONCERTO study is a phase 1/2 clinical trial evaluating the efficacy of BLU-451, a small molecule inhibitor of EGFR, in patients with advanced cancers harboring EGFR exon 20 insertion mutations. The study aims to assess the safety, recommended phase 2 dose (RP2D), and antitumor activity of BLU-451.<br /><br />EGFR exon 20 insertion mutations are a common type of EGFR activating mutation in non-small cell lung cancer (NSCLC) that are not effectively targeted by current inhibitors. Additionally, patients with EGFR exon 20 mutations often develop central nervous system (CNS) metastases, making treatment challenging.<br /><br />The phase 1 portion of the study is currently ongoing and involves dose escalation and expansion to determine the MTD and RP2D of BLU-451. The trial is planned to take place in approximately 40 centers across North America, Asia, and the European Union for the phase 2 portion.<br /><br />Key inclusion criteria for the study include being 18 years or older, having recurrent/metastatic NSCLC or other incurable cancers, and harboring EGFR exon 20 insertion mutations. Patients must also have received prior treatment for their advanced disease.<br /><br />The primary endpoints of the study include determining the MTD and RP2D of BLU-451, evaluating its safety and tolerability, and assessing antitumor activity using RECIST 1.1 criteria. Secondary endpoints include objective response rate, duration of response, disease control rate, clinical benefit rate, progression-free survival, overall survival, and CNS antitumor activity.<br /><br />The study will also assess the pharmacokinetics of BLU-451 and may include biomarker assessments using circulating tumor DNA or tumor biopsy.<br /><br />The poster provides information about the study design, study objectives, key eligibility criteria, and study endpoints. It highlights the need for effective treatments for patients with EGFR exon 20 insertion mutations and CNS metastases. The study aims to contribute to the development of a potential new treatment option for these patients.

Asset Subtitle

Alexander Spira

Meta Tag

Speaker Alexander Spira

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

Keywords

CONCERTO study

phase 1/2 clinical trial

BLU-451

small molecule inhibitor

EGFR

advanced cancers

EGFR exon 20 insertion mutations

safety

recommended phase 2 dose

antitumor activity