Dizal (SSE:688192) reported new clinical data for sunvozertinib NSCLC at the 2026 European Lung Cancer Congress in Copenhagen, showing an 81.3% objective response rate when the oral EGFR inhibitor, marketed as Zegfrovy, was used as first-line monotherapy in patients with advanced non-small cell lung cancer harboring EGFR P-loop and αC-helix compressing mutations or other uncommon EGFR variants. The data, drawn from a single-arm cohort dosed at the recommended Phase III level of 300 mg daily, position the drug as a potential oral alternative in a molecular subgroup where platinum-doublet chemotherapy has remained the default option.
EGFR PACC Mutations and the Treatment Gap in NSCLC
PACC mutations account for roughly 12.5% of all EGFR mutations detected in NSCLC. Unlike the classical exon 19 deletions and L858R point mutations that respond reliably to approved tyrosine kinase inhibitors such as osimertinib, PACC and other uncommon EGFR variants have historically been associated with limited benefit from existing targeted agents. Patients carrying these mutations tend to have a worse prognosis, and the absence of a labeled targeted therapy has left chemotherapy as the standard first-line approach.
Afatinib (Gilotrif), marketed by Boehringer Ingelheim, is the only EGFR inhibitor with a US FDA label that extends to specific uncommon mutations — namely S768I, L861Q, and G719X — based on data from the LUX-Lung trials. However, that label does not encompass the broader PACC category, and afatinib's pan-ErbB mechanism carries a toxicity burden that includes severe diarrhea, stomatitis, and paronychia. No approved therapy specifically addresses EGFR PACC mutations as a defined molecular subgroup, a gap that Dizal's sunvozertinib ELCC 2026 presentation aimed to highlight.
Sunvozertinib NSCLC: Efficacy Data From the ELCC Presentation
At the congress, Dizal presented results from treatment-naïve patients with advanced NSCLC harboring EGFR PACC or other uncommon mutations who received Zegfrovy as first-line treatment at 300 mg once daily. Per investigator assessment, tumor shrinkage was observed in 100% of evaluable patients. The sunvozertinib objective response rate was 81.3%, with a disease control rate of 100%.
Activity was also observed in the central nervous system. Among 15 patients with previously untreated baseline brain metastases, 11 showed tumor response, including six with confirmed partial responses. As of the data cutoff, median duration of response had not been reached, with an estimated 6-month durable response rate of 87.5%. Progression-free survival data were immature, but the estimated 9-month PFS rate was 83.9%. Approximately 81.3% of patients remained on treatment at the time of the data snapshot.
The safety profile was described as consistent with prior sunvozertinib studies, with no new signals. Most treatment-emergent adverse events were grade 1 or 2 and clinically manageable.
These figures require careful interpretation. The cohort is small, the data are investigator-assessed rather than independently reviewed, and survival endpoints have not matured. Cross-trial comparisons are limited by differences in patient populations, mutation subtypes, and study designs.
ZEGFROVY First-Line Treatment: Context Within Dizal's Broader Program
Zegfrovy is already approved in the United States and China for a different EGFR mutation subtype — exon 20 insertion mutations — in the second-line setting, specifically for patients whose disease has progressed on or after platinum-based chemotherapy. The US approval was supported by the multinational WU-KONG1 Part B study, while the Chinese approval drew on the WU-KONG6 trial.