Watch out, Johnson & Johnson. Dizar has reported positive Phase 3 results for oral Zegflovy, which could put further pressure on the pharmaceutical giant’s injectable Librevant for non-small cell lung cancer (NSCLC).
The global phase 3 Wu-Kong28 trial testing Zegflovi (sambozertinib) as monotherapy met its primary endpoint, Dizal announced on Saturday. EGFR tyrosine kinase inhibitors significantly improved progression-free survival (PFS) compared with platinum-based chemotherapy in previously untreated NSCLC patients with EGFR exon 20 insertion mutations.
In addition to a “statistically significant and clinically meaningful” improvement in PFS, Professor Dizal also reported “excellent results” for Zegfrovy in all secondary endpoints measuring tumor response rate and duration, and a safety profile consistent with previous studies.
The success of the Wu-Kong28 study positions Zegfrovy as the first oral chemotherapy-free regimen to demonstrate superior clinical efficacy over standard chemotherapy in the first-line EGFR exon 20 NSCLC setting.
The positive outlook sets the stage for Johnson & Johnson’s continued battle in the market with LiveLevant. Rybrevant, which received FDA first-line approval two years ago, is an injectable bispecific antibody that must be used in conjunction with chemotherapy. As a single-drug oral regimen, Dizal’s Zegfrovy may represent a more convenient and less toxic alternative.
But before Disal can claim competitiveness, the Wu-Kong28 results need to be compared to J&J’s Papillon test. This trial showed that live levant plus chemotherapy reduced the risk of disease progression or death by 61% compared to chemotherapy alone.
Detailed data from Wu-Kong28 will be presented at an upcoming medical conference, and Dizal said he plans to work with regulators on potential pharmaceutical applications.
“Finding drugs that target EGFR exon 20 insertion mutations is particularly challenging because of their enormous diversity,” Dizal CEO Dr. Xiaolin Zhang said in a March 21 statement. “Despite tremendous efforts, we have not yet succeeded in finding effective targeted drugs to save patients from chemotherapy. The WU-KONG28 study has the potential to change everything.”
Prior to Zegfrovy, Takeda Pharmaceutical’s small molecule TKI Exkivity (mobocertinib) failed in studies in the first-line EGFR exon 20 setting and will be withdrawn from the global market in 2023.
Depending on how the FDA views Wu-Kong28’s results, Dizal could fully approve accelerating Zegflovy’s approval for previously treated patients.
Dr. Dizal also recently initiated a Phase 3 trial, currently believed to be conducted only in China, testing Zegflovy as an adjuvant therapy for stage 1b to 3a NSCLC with EGFR exon 20 insertions or PACC mutations.
Disal, which was spun out from AstraZeneca, reported sales of 801 million Chinese yuan ($116 million) in 2025, representing a 123% year-on-year jump after its two commercial products (Zegflovy and the c-Met/VEGFR2 inhibitor gorvatinib) were included in China’s national insurance system.
The Chinese biotech company is expanding its pipeline, which also includes birelentinib, a first-in-class non-covalent dual LYN/BTK inhibitor at a pivotal stage, and is aiming for a second listing on the Hong Kong Stock Exchange.
Meanwhile, beyond the unusual Exon 20 setup, J&J is expending significant energy in a high-stakes battle with AZ’s EGFR king Tagrisso in the larger Exon 19/Exon 21 market. After delays, J&J was able to improve Rybrevant’s convenience and safety, as well as its efficacy, and it received FDA approval for subcutaneous administration.
