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Gregory J. Riely, MD, PhD
Gregory J. Riely, MD, PhD
Posted: Friday, September 27, 2024
A study presented at the European Society for Medical Oncology (ESMO) Congress 2024 (Abstract 1254MO) highlighted safety and efficacy data from a phase IIb REZILIENT1 study of zipalertinib in cohort C patients with EGFR exon 20 insertion–mutated non–small cell lung cancer (NSCLC) that progressed after therapy with the bispecific antibody amivantamab-vmjw. Antonio Passaro, MD, PhD, of the European Institute of Oncology, Milan, Italy, and colleagues reported that 37% of patients had a partial response, 50% had stable disease, and the objective response rate was 40%.
“Zipalertinib (CLN-081, TAS6417) is a novel EGFR tyrosine kinase inhibitor {TKI] that demonstrated...manageable safety in a phase I/IIa study in patients with EGFR exon 20 insertion–mutated NSCLC after prior platinum-containing chemotherapy,” stated Dr. Passaro and colleagues.
A total of 45 patients were included in this phase IIb study. Patients whose disease progressed after at least 1 year of prior treatment with amivantamab were enrolled and were administered zipalertimib orally at 100 mg twice per day.
Findings revealed that at data cutoff, 30 patients were evaluable for response. Of them, 1 patient (3%) had a complete response, 11 patients (37%) had a partial response, and 15 patients (50%) had stable disease. The objective response rate was 40%, and the disease control rate was 90%. Additionally, the median progression-free response was 9.7 months; however, the median duration of response was not yet estimable when these reports were presented.
Safety findings revealed that treatment-related adverse events in 10% or more patients were rash (38%), paronychia (36%), anemia (24%), dry skin (20%), dermatitis acneiform (16%), nausea (16%), and stomatitis (11%). Moreover, grade 3 events were reported in 14 patients, and no grade 4 or 5 events were observed.
Disclosure: For full disclosures of the study authors, visit cslide.ctimeetingtech.com.
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