News|Articles|March 23, 2026

Zegfrovy Delays Cancer Growth vs Chemotherapy in Some Lung Cancers

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Key Takeaways

Sunvozertinib achieved a statistically significant, clinically meaningful PFS advantage over platinum-based chemotherapy by blinded independent central review in newly diagnosed EGFR exon 20 insertion–mutant NSCLC.
Superiority across key secondary endpoints included higher cORR, longer DOR, and improved DCR, reinforcing a consistent efficacy signal beyond time-to-event benefit.
WU-KONG28 was an open-label, randomized, confirmatory phase 3 study spanning 16 countries, comparing once-daily oral monotherapy with standard platinum-doublet chemotherapy in the first-line setting.
Safety was consistent with prior experience, dominated by manageable grade 1–2 treatment-related events and no newly identified safety signals, supporting a chemotherapy-sparing approach.
Regulatory strategy includes engaging authorities to pursue first-line indications, leveraging existing US/China post-platinum approvals and FDA/CDE Breakthrough Therapy Designations.

Zegfrovy helped patients live longer without cancer growth and improved tumor response compared with chemotherapy in first-line lung cancer treatment.

Dizal announced in a news release that the phase 3 WU-KONG28 study met its primary endpoint, showing that Zegfrovy (sunvozertinib) improved progression-free survival compared with platinum-based chemotherapy in patients with newly diagnosed non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations, offering a potential first-line, chemotherapy-free treatment option.

How did Zegfrovy improve outcomes compared with chemotherapy?

According to topline results from the WU-KONG28 study, treatment with Zegfrovy led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with platinum-containing chemotherapy doublets. PFS was the primary endpoint of the trial and was assessed by blinded independent central review.

In addition to the primary endpoint, Zegfrovy demonstrated superior outcomes across all reported secondary endpoints. These included confirmed overall response rate (cORR), duration of response (DOR) and disease control rate (DCR), all favoring the oral targeted therapy over chemotherapy.

The study findings suggest that Zegfrovy may represent the first and only oral, once-daily, chemotherapy-free targeted therapy to show meaningful clinical benefit in the first-line treatment setting for patients with NSCLC harboring EGFR exon 20 insertion mutations.

Investigators noted that EGFR exon 20 insertion mutations are highly diverse, with more than 100 identified subtypes, which has made it difficult to develop effective targeted therapies. The positive results from this trial indicate that Zegfrovy may address this unmet need for patients with this type of lung cancer.

Zegfrovy is already approved in both the United States and China for patients with locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutations whose disease has progressed on or after platinum-based chemotherapy. Based on the WU-KONG28 results, the company plans to engage with regulatory authorities regarding potential new drug applications for use in the first-line setting.

What were the design and scope of the WU-KONG28 trial?

WU-KONG28 is a multinational, open-label, randomized confirmatory phase 3 study evaluating Zegfrovy compared with platinum-based chemotherapy as first-line treatment for patients with advanced NSCLC with EGFR exon 20 insertion mutations.

The trial enrolled patients across 16 countries and regions spanning Asia, Europe, North America and South America, reflecting a broad global population of patients with this disease.

Participants were randomly assigned to receive either Zegfrovy monotherapy, given as an oral, once-daily treatment, or standard platinum-based chemotherapy doublet. The study’s primary endpoint was progression-free survival, with additional secondary endpoints including cORR, DOR and DCR.

Detailed results from the primary analysis are expected to be presented at an upcoming international scientific congress.

Zegfrovy is an irreversible EGFR inhibitor designed to target a wide range of EGFR mutations while maintaining selectivity for wild-type EGFR. Beyond EGFR exon 20 insertion mutations, the drug has also shown anti-tumor activity in patients with other EGFR mutations, including sensitizing and T790M mutations, as well as HER2 exon 20 insertion mutations.

In the first-line setting, Zegfrovy has received Breakthrough Therapy Designations from both the U.S. Food and Drug Administration and the China Center for Drug Evaluation.

What side effects were reported with Zegfrovy?

Zegfrovy was reported to be generally well tolerated in the WU-KONG28 study, with a safety profile consistent with previous clinical findings.

The most common treatment-related side effects were grade 1 (mild) or 2 (moderate) in severity and were described as clinically manageable. No new safety signals were reported in the topline results.

Overall, the safety findings support the use of Zegfrovy as a potential first-line treatment option, particularly as an oral, chemotherapy-free alternative for patients with NSCLC with EGFR exon 20 insertion mutations.

Editor's note: This article is for informational purposes only and is not a substitute for professional medical advice, as your own experience will be unique. Use this article to guide discussions with your oncologist. Content was generated with AI, reviewed by a human editor, but not independently verified by a medical professional.