Phase 3 Trial Launches to Assess EGFR Inhibitor for NSCLC Subset

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Researchers conducting this trial will compare zipalertinib plus chemotherapy with chemotherapy alone in patients with previously untreated, locally advanced or metastatic non-small cell lung cancer with the EGFR exon 20 insertion mutation.

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A phase 3 trial is investigating a new treatment regimen for patients with locally advanced or metastatic EGFR exon 20 insertion-mutant non-small cell lung cancer.

A phase 3 trial was launched assessing zipalertinib plus chemotherapy as a treatment for patients with previously untreated, locally advanced or metastatic non-small cell lung cancer (NSCLC) with the EGFR exon 20 insertion mutation.

Researchers conducting the REZILIENT3 trial will aim to enroll approximately 312 patients, according to a press release from Taiho Oncology and Cullinan Oncology, the manufacturers of the drug.

“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 ziparlertinib to help more patients with EGFR exon 20 insertion mutation NSCLC,” Dr. Jeffrey Jones, chief medical officer of Cullinan Oncology, said in the release.

In the REZILIENT3 trial, patients with previously untreated, locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations will be randomly assigned either zipalertinib plus chemotherapy or chemotherapy alone, according to the release. Researchers aim to assess progression-free survival, which is the time during and after treatment when a patient with cancer is alive without disease worsening.

Zipalertinib is an EGFR inhibitor that targets activating mutations in EGFR, according to the release. It has previously received a breakthrough therapy designation from the Food and Drug Administration, meaning that the agency will aim to expedite the development and review of this drug as it previously demonstrated substantial improvement over available standard-of-care options, according to the agency’s website.

Up to 4% of patients with NSCLC harbor EGFR exon 20 insertion mutations, according to the release, making it the third most common EGFR mutation subtype. The EGFR exon 20 insertion mutation affects approximately 12% of all EGFR mutations in patients with NSCLC in the United States.

“Patients with NSCLC who have EGFR exon 20 insertion mutations are known to have poorer outcomes than those with more common EGFR mutations,” said Dr. Volker Wacheck, senior vice president of Taiho Oncology, in the release. “Advancing care for this subset of patients with NSCLC is essential to advancing care in NSCLC overall.”

The development of this phase 3 trial is a result of findings from a phase 1/2a trial, which focused on treating patients with NSCLC and EGFR exon 20 insertion mutations with zipalertinib. According to the findings published in the Journal of Clinical Oncology, zipalertinib demonstrated preliminary antitumor activity in previously treated patients with NSCLC and EGFR exon 20 insertion mutations.

Findings from the 1/2a trial also showed an acceptable safety profile with zipalertinib, according to the published study. The most frequently reported treatment-related side effects of any severity included paronychia (an infection of the folds around finger- and toenails), rash, fatigue and diarrhea.

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