AstraZeneca has completed its global licensing agreement with Dizal Pharmaceutical for Zegfrovy (sunvozertinib), an oral targeted therapy for patients with EGFR exon 20 insertion-mutated non-small cell lung cancer (NSCLC).
Under the agreement, AstraZeneca has acquired worldwide rights to develop and commercialize Zegfrovy, expanding the company’s portfolio of treatments targeting epidermal growth factor receptor (EGFR) mutations in lung cancer.
Zegfrovy Already Approved in the US and China
Zegfrovy is an oral, irreversible EGFR inhibitor designed to target a broad spectrum of EGFR mutations while maintaining selectivity against wild-type EGFR.
The therapy is approved in the United States and China for adults with locally advanced or metastatic NSCLC harboring EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy.
The US Food and Drug Administration granted Zegfrovy accelerated approval in July 2025 based on results from the WU-KONG1B trial, where the confirmed overall response rate was 46%, with a median duration of response of 11.1 months.
Zegfrovy is already commercially available in China, and AstraZeneca plans to launch the treatment in the United States in the fourth quarter of 2026.
First-Line Zegfrovy Under FDA Review
AstraZeneca is also looking to move Zegfrovy into the first-line setting.
The FDA has accepted a supplemental New Drug Application for Zegfrovy as a first-line treatment for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations. An application has also been submitted to China’s Center for Drug Evaluation.
The submissions are supported by results from the global Phase 3 WU-KONG28 trial (NCT05668988), which enrolled 324 patients and compared first-line sunvozertinib with platinum-based chemotherapy.
In the study, median progression-free survival was 10.3 months with sunvozertinib versus 7.5 months with chemotherapy, corresponding to a 35% reduction in the risk of disease progression or death (HR 0.65; 95% CI, 0.50–0.85; P<0.001).
The objective response rate was 58.9% with sunvozertinib compared with 31.1% with chemotherapy. Overall survival data were immature at the time of analysis. The findings were presented at the 2026 ASCO Annual Meeting and published in The New England Journal of Medicine (DOI: 10.1056/NEJMoa2604461).
Both the FDA and China’s CDE have granted Zegfrovy Breakthrough Therapy Designation for the first-line setting.
ASCO 2026: Sunvozertinib Versus Chemotherapy in First-Line EGFR exon20ins Advanced NSCLC
Agreement Worth Up to $1.5 Billion
Under the completed transaction, AstraZeneca will pay Dizal $600 million upfront, with up to an additional $900 million tied to development, regulatory and commercial milestones.
Dizal will also receive tiered royalties on global Zegfrovy sales. AstraZeneca stated that the transaction will not affect its 2026 financial guidance.
When the agreement was initially announced in July 2026, Dave Fredrickson, Executive Vice President of AstraZeneca’s Oncology Haematology Business Unit, said:
“AstraZeneca is a leader in treating EGFR-mutated lung cancer, and we are eager to add Zegfrovy to our world-class portfolio of innovative medicines for patients whose tumours carry exon 20 insertion mutations.”
The completion of the agreement adds another targeted therapy to AstraZeneca’s growing lung cancer portfolio as the company seeks to expand treatment options across different EGFR-mutated NSCLC populations.
Read further on OncoDaily: AstraZeneca and Daiichi Sankyo’s Enhertu Improves PFS in First-Line HER2-Mutant Advanced NSCLC in Phase III DESTINY-Lung04
