Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc. announced the launch of the REZILIENT3 trial (NCT05973773, Researching Zipalertinib In EGFR Non-Small Cell Lung Cancer Tumors), a global Phase 3 clinical trial evaluating the combination of zipalertinib and chemotherapy as a potential first-line treatment for adult patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutation and who meet additional criteria. NSCLC is a common form of lung cancer and up to 4% of all cases have EGFR exon 20 insertions, which makes them the third most common EGFR mutation subtype. In the United States, approximately 16% of patients with NSCLC harbor EGFR mutations, with insertions at exon 20 accounting for up to 12% of these mutations.

The launch of the REZILient3 trial follows a Phase 1 /2a clinical trial (NCT04036682) of zipalertinib in patients with NSCLC harboring EGFR exon 20 insertion mutations. Results demonstrated the therapeutic potential of zipalertinib In heavily pretreated patients and were presented at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting. Updated data from this trial were recently published in the Journal of Clinical Oncology.

REZILIENT3 Trial This multicenter, randomized, controlled, open-label global trial is currently enrolling adults with previously untreated, locally advanced or metastatic non-squamous NSCLC with EGFR exon 20 insertion mutations. The primary objective of this trial is to assess progression-free survival in the zipalertinib plus chemotherapy arm versus the chemotherapy arm. Approximately 312 patients will ultimately be enrolled in this trial from around the world.