As reported on FiercePharma, China-based biotech Dizal Pharmaceutical has reported a pivotal phase 3 success for its oral EGFR inhibitor Zegfrovy (sunvozertinib), marking a potential shift in first-line treatment for a difficult-to-treat subtype of non-small cell lung cancer (NSCLC).
According to the company, the global Wu-Kong28 trial met its primary endpoint by demonstrating a significant improvement in progression-free survival compared with platinum-based chemotherapy in previously untreated patients whose tumors harbor EGFR exon 20 insertion mutations. These alterations are known for their biological diversity and resistance to many approved EGFR therapies, making advances in this setting particularly challenging.
Beyond the primary endpoint, Zegfrovy also performed favorably across a range of secondary measures, including objective response rate, duration of response, and overall safety. Dizal said the safety profile observed in Wu-Kong28 was consistent with earlier studies of the drug, reinforcing its tolerability as a monotherapy.
If confirmed in peer-reviewed data, Wu-Kong28 positions Zegfrovy as the first oral, chemotherapy-free option to outperform standard chemotherapy in the first-line EGFR exon 20 insertion population. This distinction could prove meaningful for patients and clinicians seeking alternatives to infusion-based regimens.
Competitive Pressure on Rybrevant
The positive readout intensifies competition with Johnson & Johnson’s Rybrevant (amivantamab), which received FDA approval in the first-line exon 20 setting in combination with chemotherapy. Rybrevant is an injectable bispecific antibody, whereas Zegfrovy is a small-molecule EGFR tyrosine kinase inhibitor taken orally, a difference that may translate into greater convenience and potentially lower treatment burden.
However, the competitive comparison is not yet definitive. J&J’s Papillon study showed that adding Rybrevant to chemotherapy reduced the risk of disease progression or death by 61% compared with chemotherapy alone. Detailed efficacy and subgroup data from Wu-Kong28 have not yet been disclosed, and cross-trial comparisons will be closely scrutinized once full results are presented at a future medical meeting.
Dizal has indicated it plans to engage regulators regarding potential filings based on the Wu-Kong28 data. Depending on regulatory feedback, the results could also support conversion of Zegfrovy’s existing accelerated approval in previously treated patients into a full approval.
Broader Context and Pipeline Momentum
Attempts to develop oral EGFR inhibitors for exon 20 insertions have had mixed success. Takeda’s mobocertinib, once billed as a breakthrough, was withdrawn globally in 2023 after failing to demonstrate sufficient benefit in the frontline setting. Against that backdrop, Wu-Kong28 represents a notable reversal of fortunes for the small-molecule approach.
Dizal is also expanding Zegfrovy’s development into earlier disease stages, with a phase 3 adjuvant trial underway in China for resected NSCLC with EGFR exon 20 insertion or PACC mutations. Commercially, the company reported strong revenue growth in 2025 following national insurance coverage in China for Zegfrovy and golvatinib.
As J&J continues to defend its EGFR franchise—both in exon 20 disease and against AstraZeneca’s Tagrisso in more common EGFR mutations—Wu-Kong28 signals that competition in this niche is far from settled. Full disclosure of the data will determine whether Zegfrovy can claim a durable clinical and commercial advantage.
