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(Abstract)

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This document is a summary of a presentation at the WCLC 2023 conference on metastatic non-small cell lung cancer (NSCLC) targeted therapy, specifically focusing on EGFR/HER2. The study presented is a phase I/II clinical trial exploring the safety and efficacy of Apl-101 in combination with frontline osimertinib in patients with EGFR-mutated metastatic NSCLC. The activation of MET signaling has been identified as a driver of resistance to osimertinib, and low copy number gains in MET have also been observed in treatment-naive patients with EGFR-mutated NSCLC. The hypothesis is that dual EGFR and MET inhibition could lead to significant and long-lasting responses in the frontline setting.<br /><br />The study is an ongoing open-label single-center trial. Patients are initially treated with osimertinib alone for 8-16 weeks, followed by combination treatment if there is no evidence of disease progression. The primary endpoints of the study are toxicity assessment for phase I and progression-free survival at 12 months for phase II. Secondary endpoints include maximum tolerated dose, overall response rate, duration of response, and overall survival.<br /><br />The dosing schedule for Apl-101 in combination with osimertinib is outlined in table 1. The trial is currently in dose level 2, with dose level 1 having been completed. Safety is assessed through adverse events monitoring, physical exams, laboratory assessments, ECG, and ECHO.<br /><br />The study also includes correlative studies to identify genomic alterations and biomarkers that predict the benefit of combination therapy. Blood and tumor biopsy samples are collected at various time points in the study for exploratory analyses.<br /><br />This presentation highlights the ongoing clinical trial investigating the potential of Apl-101 and osimertinib combination therapy in treating EGFR-mutated metastatic NSCLC.

Asset Subtitle

Siddhartha Devarakonda

Meta Tag

Speaker Siddhartha Devarakonda

Topic Metastatic NSCLC: Targeted Therapy - EGFR/HER2

Keywords

metastatic non-small cell lung cancer

NSCLC

targeted therapy

EGFR/HER2

phase I/II clinical trial

Apl-101

osimertinib

MET signaling

EGFR-mutated NSCLC

frontline setting