Watch out, Johnson & Johnson. Dizal has reported positive phase 3 results for its oral Zegfrovy that could put more pressure on the pharma giant’s injectable Rybrevant in non-small cell lung cancer (NSCLC).
The global phase 3 Wu-Kong28 trial, which tested Zegfrovy (sunvozertinib) as a monotherapy, has met its primary endpoint, Dizal announced Saturday. The EGFR tyrosine kinase inhibitor (TKI) significantly improved progression-free survival (PFS) versus platinum-based chemotherapy in treatment-naïve patients with NSCLC harboring EGFR exon 20 insertion mutations.
In addition to the “statistically significant and clinically meaningful” improvement in PFS, Dizal also reported “superior results” for Zegfrovy in all secondary endpoints, which are measuring tumor response rates and duration as well as a safety profile that’s consistent with previous studies.
The success of the Wu-Kong28 study positions Zegfrovy as the first oral, chemo-free regimen to demonstrate superior clinical benefit over standard chemo in the first-line EGFR exon 20 NSCLC setting.
The positive readout sets the stage for a continued market battle with Johnson & Johnson’s Rybrevant. While Rybrevant got its first-line FDA approval two years ago, it is an injectable bispecific antibody that needs to be used in combination with chemo. As a single-agent oral regimen, Dizal’s Zegfrovy could offer a potentially more convenient and less toxic alternative.
However, before Dizal can claim a competitive edge, the Wu-Kong28 results need to be benchmarked against J&J’s Papillon trial, which showed Rybrevant plus chemo resulted in a 61% reduction in the risk of disease progression or death versus chemo alone.
Detailed data from Wu-Kong28 will be presented at an upcoming medical meeting, and Dizal said it plans to engage with regulatory authorities about potential drug applications.
“Finding a drug targeting EGFR exon 20 insertion mutations is especially challenging due to their enormous heterogeneity,” Dizal CEO Xiaolin Zhang, Ph.D., said in a March 21 statement. “Despite tremendous efforts, there is no success yet in finding an effective target drug that can spare patients from chemotherapies. WU-KONG28 study has the potential to change all that.”
Before Zegfrovy, Takeda’s small-molecule TKI Exkivity (mobocertinib) failed a study in the first-line EGFR exon 20 setting, leading to a global market withdrawal in 2023.
Depending how the FDA views the Wu-Kong28 results, Dizal could also turn Zegfrovy’s accelerated approval in previously treated patients into a full nod.
Dizal also recently launched what currently appears to be a China-only phase 3 trial testing Zegfrovy as an adjuvant therapy in stage 1b to 3a NSCLC with EGFR exon 20 insertion mutations or PACC mutations.
A spinout from AstraZeneca, Dizal reported 2025 revenue of 801 million Chinese yuan ($116 million), which represents a 123% jump over the prior year after the company’s two commercial products—Zegfrovy and c-Met/VEGFR2 inhibitor golvatinib—landed coverage on China’s national insurance scheme.
With an expanding pipeline that also includes the pivotal-stage, potential first-in-class noncovalent LYN/BTK dual inhibitor birelentinib, the Chinese biotech is seeking a second listing on the Hong Kong Stock Exchange.
Meanwhile, other than the rare exon 20 setting, J&J is spending much energy on a high-stakes battle with AZ’s EGFR king Tagrisso in the bigger exon 19/exon 21 market. After a delay, J&J managed to improve Rybrevant’s convenience and safety profile—and seemingly also efficacy—with an FDA approval for a subcutaneous version.