Another hollow victory for Dizal

Dizal’s success with Zegfrovy in lung cancer with EGFR exon 20 insertions seems at odds with its ability actually to get the drug to US patients. On Saturday the company scored another clinical trial win, toplining the first-line phase 3 WU-Kong28 study as statistically significant and clinically meaningful for PFS, its primary endpoint, setting up what could be the second US approval for Zegfrovy, which was got accelerated US approval for chemo-progressed disease last July. Despite this Zegfrovy remains out of reach for most US patients because Dizal has neither a commercial presence nor a licensing partner outside China. WU-Kong28 compared Zegfrovy against chemo, and Dizal said it also showed “superior results in all secondary endpoints”, but didn’t name overall survival, or say whether such results were statistically significant. Data will be presented at an upcoming scientific meeting, and as well as backing an imminent filing they could convert Zegfrovy’s second-line nod into full US approval. EGFR exon 20 insertion lung cancer is a niche setting, but the data will be most relevant for Otsuka and Cullinan, which are running the phase 3 Rezilient-3 trial of zipalertinib; however, in contrast to WU-Kong28, Rezilient-3 concerns a chemo combo.

Pivotal studies in 1st-line EGFR exon 20ins NSCLC

Source: OncologyPipeline.