2023 World Conference on Lung Cancer (Posters)-P2.09. Phase I/II Study Exploring Safety and Efficacy of Apl-101 Plus Frontline Osimertinib in EGFR-mutated Metastatic Non-small Cell Lung Cancer

P2.09. Phase I/II Study Exploring Safety and Efficacy of Apl-101 Plus Frontline Osimertinib in EGFR-mutated Metastatic Non-small Cell Lung Cancer - PDF(Slides)

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This document introduces a phase I/II study that aims to explore the safety and efficacy of the combination therapy with APL-101, a MET inhibitor, and osimertinib, an EGFR-TKI, in patients with metastatic non-small cell lung cancer (NSCLC) who have EGFR mutations. The activation of MET signaling has been identified as a driver of resistance to EGFR TKIs in lung cancer. The study will involve a dose escalation phase to determine the maximum tolerated dose and dose-limiting toxicities, followed by a cohort expansion phase. The objectives of the study include assessing progression-free survival at one year, overall response rate, duration of response, and overall survival. The researchers also plan to conduct exploratory analyses to investigate genomic alterations underlying drug tolerance and identify biomarkers that are prognostic and predictive of treatment response. The study is currently recruiting patients at dose level 2. Inclusion criteria for eligible patients include having metastatic NSCLC with TKI-sensitive EGFR mutations and measurable disease. Patients who have previously received osimertinib in the metastatic setting or prior immunotherapy treatment are excluded. The study protocol number is 202104039, and the clinical trial identifier is NCT04743505. The study will involve a combination of APL-101 and osimertinib administered in a 28-day cycle, with assessment of response through imaging and biopsies. The document also provides the author affiliations, acknowledging funding support from Apollomics Inc.

Asset Subtitle

Siddhartha Devarakonda

Meta Tag

Speaker Siddhartha Devarakonda

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

combination therapy

MET inhibitor

EGFR-TKI

metastatic non-small cell lung cancer

EGFR mutations

dose escalation phase

progression-free survival

genomic alterations

biomarkers

clinical trial identifier