AstraZeneca Launches ZEGFROVY In The U.S., Expanding Targeted Treatment Options For EGFR Exon 20 Insertion-Mutated Lung Cancer

Only approved oral, single agent, targeted therapy for these patients following platinum-based chemotherapy

Launch expands AstraZeneca’s commitment to addressing substantial unmet need across the spectrum of EGFR-mutated lung cancer with a proven portfolio of medicines targeting EGFR mutations

AstraZeneca today announced the US availability of ZEGFROVY® (sunvozertinib) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have epidermal growth factor receptor (EGFR) exon 20 insertion mutations, as detected by an FDA-approved test, and whose disease has progressed on or after platinum-based chemotherapy.1

The US Food and Drug Administration granted accelerated approval to ZEGFROVY based on results from the WU-KONG1B trial.2 In the open-label, dose randomization clinical trial, ZEGFROVY demonstrated a confirmed overall response rate of 46% (n=85; 95% confidence interval [CI] 35, 57) and a median duration of response of 11.1 months in those responders (n=39; 95% CI 8.2, NE).1 Seventy-two percent of responding patients (n=39) observed duration of response for at least six months.1 Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

EGFR exon 20 insertion mutations represent a distinct and hard-to-treat form of EGFR-mutated NSCLC.3 Patients have historically had limited targeted treatment options and poor outcomes, with real-world evidence showing a five-year overall survival rate as low as 8%.3