Dizal's Zegfrovy Meets Phase III NSCLC Endpoint as Other Trials Fail

Dizal's Phase III WU-KONG28 trial of Zegfrovy (sunvozertinib) for first-line treatment of non-small cell lung cancer with epidermal growth factor receptor exon 20 insertion mutations has met its primary endpoint. The multinational study revealed positive topline data and demonstrated that Zegfrovy improved progression-free survival compared to platinum-based doublet chemotherapy.

The randomised confirmatory, open-label trial enrolled patients across 16 countries and regions in Europe, Asia, South America, and North America. The primary endpoint was progression-free survival evaluated by blinded independent central review. Detailed data from the primary analysis will be submitted for presentation at an upcoming international scientific congress.

Zegfrovy was previously approved in both China and the US for relapsed or refractory NSCLC with EGFR exon20ins. In the first-line setting, it has received breakthrough therapy designations from both the US Food and Drug Administration and China Center for Drug Evaluation. Dizal plans to engage regulatory authorities regarding potential new drug applications based on these results.

Meanwhile, other late-stage lung cancer trials have faced setbacks. Immutep is halting its Phase III TACTI-004 trial of eftilagimod alfa combined with Merck's Keytruda in patients with first-line non-small cell lung cancer. The study's independent data monitoring committee had recommended discontinuing the 756-patient randomized trial.

Additionally, the LATIFY Phase III trial of ceralasertib in combination with Imfinzi (durvalumab) did not meet the primary endpoint of overall survival versus standard-of-care docetaxel in patients with locally advanced or metastatic non-small cell lung cancer. The trial evaluated patients without actionable genomic alterations whose disease progressed on or after prior immunotherapy and platinum-based chemotherapy.

The combination of ceralasertib and Imfinzi was generally well tolerated, and the safety profile was consistent with the known profiles of each individual medicine, with no new safety concerns identified. These data will be presented at a forthcoming medical meeting.

Zegfrovy is described as an irreversible EGFR inhibitor targeting a range of EGFR mutations with wild-type selectivity. The company noted that finding a drug targeting EGFR exon 20 insertion mutations is especially challenging due to their enormous heterogeneity, with over one hundred different subtypes of EGFR exon20ins identified clinically.