Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics have reported that the global Phase III REZILIENT3trial assessing zipalertinib combined with platinum-based chemotherapy for the first-line treatment of certain non-small cell lung cancer (NSCLC) patients has achieved its primary endpoint.
The study included adults with previously untreated, locally advanced or metastatic non-squamous NSCLC harbouring epidermal growth factor receptor (EGFR) exon 20 insertion (ex20ins) mutations.
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The randomised, multi-centre, open-label, controlled trial enrolled 285 adults.
Based on interim analysis, it was observed that adults with locally advanced or metastatic NSCLC treated with zipalertinib and platinum-based chemotherapy experienced a statistically significant improvement in progression-free survival.
The improvement was also considered clinically meaningful compared to those given chemotherapy alone. Safety outcomes for patients receiving zipalertinib were manageable.
An Independent Data Monitoring Committee has recommended unblinding the study on the basis of these interim results, and the trial will continue to follow participants for efficacy and safety.
Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics plan to seek regulatory approval for zipalertinib in combination with chemotherapy for first-line treatment of this patient group in the US, following discussions with the US Food and Drug Administration (FDA) regarding these findings.
Taiho Oncology chief medical officer Harold Keer said: “The positive topline results from the planned interim analysis of REZILIENT3 further support the potential of zipalertinib to meet the high unmet medical need in patients with NSCLC harboring EGFR exon 20 insertion mutations.
“We look forward to pursuing regulatory approval of zipalertinib in combination with chemotherapy in the first-line treatment setting with the goal of providing a new treatment option for this group of patients.”
Zipalertinib, also known as CLN-081/TAS6417, is an oral investigational small molecule designed to inhibit EGFR with exon 20 insertion mutations.
The therapy is being developed by Taiho Oncology, Taiho Pharmaceutical and Cullinan Therapeutics and has not been approved by any health regulatory authority.
