On August 3, 2023 Taiho Oncology, Inc., Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc., reported 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 (Press release, Taiho, AUG 3, 2023, View Source [SID1234633795]).

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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.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

"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."

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) (Free ASCO Whitepaper) Annual Meeting.2 Updated data from this trial were recently published in the Journal of Clinical Oncology.3

"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 Oncology, Inc. "We look forward to working with our partners at Taiho to rapidly assess zipalertinib in the front line, while in parallel continuing to advance our pivotal Phase 2b trial in patients who have received prior systemic treatment for locally advanced or metastatic disease."

About the 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.

About Zipalertinib
Zipalertinib (development code: CLN-081/TAS6417) is an orally available small molecule designed to target activating mutations in EGFR. The molecule was engineered to inhibit EGFR variants with exon 20 insertion mutations, while sparing wild-type EGFR. Zipalertinib is designed as a next generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with non-small cell lung cancer. Zipalertinib has received Breakthrough Therapy Designation from the FDA.

Zipalertinib is being developed by Taiho Oncology, Inc., its parent company, Taiho Pharmaceutical Co., Ltd., and Cullinan Oncology, Inc. Cullinan Pearl Corp., which Taiho Pharmaceutical Co., Ltd., acquired from Cullinan Oncology, Inc. in 2022, previously licensed the rights to zipalertinib in Greater China to Zai Lab Limited in 2020.