Zipalertinib combined with platinum-based chemotherapy met the primary endpoint of progression-free survival in a planned interim analysis of the global Phase 3 REZILIENT3 trial in previously untreated advanced non-small cell lung cancer with EGFR exon 20 insertion mutations.
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics said the zipalertinib-containing regimen delivered a statistically significant and clinically meaningful improvement in progression-free survival compared with chemotherapy alone.
The companies did not disclose detailed efficacy data. They said full results will be submitted for presentation at a future international medical conference.
REZILIENT3 is evaluating zipalertinib plus standard first-line platinum-based chemotherapy in adults with locally advanced or metastatic non-squamous non-small cell lung cancer harboring EGFR exon 20 insertion mutations. The multicenter, randomized, controlled and open-label trial enrolled 285 patients who had not received previous systemic treatment for advanced disease.
The trial’s independent data monitoring committee recommended that the study be unblinded based on the interim findings. The companies said the trial will continue to monitor efficacy and safety.
The observed safety profile for the zipalertinib combination was manageable, according to the companies. Additional safety and efficacy results are expected to be reported as the study continues.
Jeffrey Jones, Cullinan Therapeutics’ chief medical officer, said reaching the endpoint early in a planned interim analysis marks an important milestone and supports the potential role of zipalertinib in the first-line setting.
The companies plan to discuss the results with FDA and, pending those discussions, pursue U.S. regulatory approval for zipalertinib combined with chemotherapy as a first-line treatment option for the mutation-defined lung cancer population.
Zipalertinib is an oral, irreversible tyrosine kinase inhibitor designed to target EGFR exon 20 insertion mutations. These mutations occur in a subset of patients with non-small cell lung cancer and are associated with limited treatment options.
Taiho Oncology and Taiho Pharmaceutical are developing zipalertinib with Cullinan Therapeutics. The companies said the Phase 3 results could represent an advance for patients with advanced EGFR exon 20 insertion-mutated non-small cell lung cancer who are beginning treatment.
The study’s progression-free survival endpoint compares the time until disease progression or death between patients receiving zipalertinib plus chemotherapy and those receiving chemotherapy alone.
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