A combination of zipalertinib and chemotherapy will be evaluated as a treatment for adults.
Taiho Oncology has announced the launch of its phase 3 REZILIENT3 study to evaluate zipalertinib, combined with chemotherapy, as a first-line treatment among adult patients with previously untreated locally advanced or metastatic non-small cell lung cancer (NSCLC) harbouring the epidermal growth factor receptor (EGFR) exon 20 insertion mutation.
The randomised, multi-location, open-label, global trial is currently enrolling adults and aims to analyse progression-free survival in the zipalertinib plus chemotherapy arm versus the chemotherapy arm. Ultimately, around 312 global patients will be recruited to participate.
The launch of the trial follows the phase 1/2a stages of the zipalertinib trial, during which results showed the therapeutic potential of the drug in heavily pretreated patients. Updated data from this study was recently published in the Journal of Clinical Oncology.
Jeffrey Jones, chief medical officer at Cullinan Oncology, was optimistic about the latest trial: “The initiation of the phase 3 trial for zipalertinib in the first-line setting is an important step forward for this clinical research programme, as it represents an opportunity for zipalertinib to help more patients with EGFR exon 20 insertion mutation NSCLC.”
He added: “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.”
Volker Wacheck, senior vice president, Clinical Development at Taiho Oncology, concluded: “Patients with NSCLC who have EGFR exon 20 insertion mutations are known to have poorer outcomes than those with more common EGFR mutations. Advancing care for this subset of patients with NSCLC is essential to advancing care in NSCLC overall.”
NSCLC is a common form of lung cancer, and up to 4% of all cases have EGFR exon 20 insertions, making them the third most common EGFR mutation subtype.