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REZILIENT3 Global First-Line Trial of Zipalertinib Launched in Patients With Non-Small Cell Lung Cancer Harboring EGFR Exon 20 Insertion Mutations
Phase 3 trial will assess progression-free survival of zipalertinib plus chemotherapy versus chemotherapy in adult patients with previously untreated, locally
About this update from Cullinan Therapeutics, Inc.
[{"type":"text","content":"Phase 3 trial will assess progression-free survival of zipalertinib plus chemotherapy versus chemotherapy in adult patients with previously untreated, locally advanced or metastatic non-squamous non-small cell lung cancer with EGFR exon 20 insertion mutations\nPRINCETON, N.J. and CAMBRIDGE, Mass., Aug. 3, 2023 /PRNewswire/ -- Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc., announced today 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.\n\n \n \n \n \n \n \n\n \nNSCLC 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.1 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.1\n\"Patients with NSCLC who have EGFR exon 20 insertion mutations are known to have poorer outcomes than those with more common EGFR mutations,1\" said Volker Wacheck, MD, PhD, Senior Vice President, Clinical Development, Taiho Oncology, Inc. \"Advancing care for this subset of patients with NSCLC is essential to advancing care in NSCLC overall.\"\nThe 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.2 Updated data from this trial were recently published in the Journal of Clinical Oncology.3 \n\"The initiation of the Phase 3 trial for zipalertinib in the first-line setting is an important step forward for this clinical research program, as it represents an opportunity for zipalertinib to help more patients with EGFR exon 20 insertion mutation NSCLC,\" said Jeffrey Jones, MD, MPH, MBA, Chief Medical Officer, Cullinan ...