Taiho Pharmaceutical Co., Ltd., Taiho Oncology, Inc., and Cullinan Therapeutics, Inc. have announced the successful outcome of the rezilient1 trial, a phase 1/2 clinical trial of zipalertinib (development code: CLN-081/TAS6417) monotherapy in patients with non-small cell lung cancer (NSCLC) harboring the epidermal growth factor receptor (EGFR) exon 20 insertion mutations who have received prior therapy. The trial met its primary endpoint of overall response rate based on the phase 2b part of the study.
Preliminary results of the rezilient1 trial have been published in the Journal of Clinical Oncology, with full results expected to be presented at an upcoming international medical conference.
Zipalertinib, an orally available small molecule designed to target activating mutations in EGFR, has received breakthrough therapy designation from the U.S. Food and Drug Administration (FDA). It is designed to inhibit EGFR variants with exon 20 insertion mutations while sparing wild-type EGFR, making it a next-generation, irreversible EGFR inhibitor for the treatment of a genetically defined subset of patients with NSCLC.
NSCLC is a common form of lung cancer, and approximately 16% of patients with NSCLC in the United States harbor EGFR mutations, with insertions at exon 20 accounting for up to 12% of these mutations.
The companies plan to submit for U.S. regulatory approval in the second half of 2025, pending discussions with the FDA.
These developments represent a significant advancement in the treatment of NSCLC and provide hope for patients with EGFR exon 20 insertion mutations who have received prior therapy. As a result of these announcements, the company's shares have moved 3.6% on the market, and are now trading at a price of $10.83. If you want to know more, read the company's complete 8-K report here.
