2023 North America Conference on Lung Cancer (NACLC) - Posters and Abstracts-PP01.081 John Heymach NACLC23 Abstract

PP01.081 John Heymach NACLC23 Abstract

Pdf Summary

The REZILIENT2 study is a phase 2 trial evaluating the efficacy and safety of the tyrosine kinase inhibitor Zipalertinib in patients with advanced non-small cell lung cancer (NSCLC) who have uncommon epidermal growth factor receptor (EGFR) mutations, including exon 20 insertions (ex20ins) and other uncommon EGFR mutations.<br /><br />Zipalertinib has shown promising preclinical activity against a wide range of EGFR mutations, including ex20ins, and has demonstrated antitumor activity in heavily pretreated patients with EGFR ex20ins-mutant NSCLC in a previous phase 1/2a study.<br /><br />The REZILIENT2 study will consist of four cohorts of patients, based on their prior treatment and type of EGFR mutation. Cohort A will include patients who have progressed on or after first-line platinum-based chemotherapy and prior therapy targeting ex20ins. Cohort B will include patients who have not received prior treatment for advanced disease. Cohort C will include patients with ex20ins, other uncommon EGFR mutations, and central nervous system metastases. Cohort D will include patients with other uncommon non-ex20ins EGFR mutations who have progressed on or after standard systemic therapy.<br /><br />Patients in each cohort will receive Zipalertinib at a starting dose of 100 mg orally twice daily on a continuous dosing schedule. The primary endpoint of the study is the investigator-assessed objective response rate. Secondary endpoints include disease control rate, duration of response, progression-free survival, overall survival, intracranial efficacy, safety and tolerability, and pharmacokinetics.<br /><br />The estimated enrollment for the study is 40 patients per cohort, with the potential for expansion to 100 patients per cohort if predefined efficacy criteria are met.<br /><br />This study aims to provide valuable data on the efficacy and safety of Zipalertinib in patients with advanced NSCLC harboring uncommon EGFR mutations, including ex20ins, who currently have limited treatment options.

Keywords

REZILIENT2 study

Zipalertinib

NSCLC

EGFR mutations

exon 20 insertions

tyrosine kinase inhibitor

advanced lung cancer

uncommon mutations

preclinical activity

heavily pretreated patients