On March 27, 2026 Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, reported the presentation of new clinical data for ZEGFROVY (sunvozertinib) as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) harboring epidermal growth factor receptor (EGFR) P-Loop and αC-helix compressing (PACC) or other uncommon mutations. The data were presented at the 2026 European Lung Cancer Congress (ELCC), held in Copenhagen, Denmark from March 25 to 28 (#44P).
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PACC mutations account for approximately 12.5% of all EGFR mutations. Approved EGFR kinase inhibitors may have clinical activities to certain types of mutations, but overall, their clinical benefits are rather limited, and chemo doublet are the only option. Multiple studies have shown that patients with these mutations exhibit poorer prognosis than those with classical EGFR common mutations (exon 19 deletions and L858R), underscoring a significant unmet medical need for effective, well-tolerated therapies with broader activity cross the EGFR mutation spectrum.
ZEGFROVY, a rationally designed oral EGFR TKI, has demonstrated robust clinical efficacy in advanced NSCLC and potent antitumor activity in preclinical models of EGFR PACC-mutant tumors. At the recommended phase 3 dose (RP3D) of 300 mg, ZEGFROVY monotherapy demonstrated promising antitumor activity and a manageable safety profile in treatment-naïve patients with advanced NSCLC harboring EGFR PACC or other uncommon mutations.
Per investigator assessment, tumor lesion shrinkage was observed in 100% of patients, with an overall response rate (ORR) of 81.3%, and a disease control rate (DCR) of 100%.
Tumor response was also observed in 11 out of 15 patients with previously-untreated baseline brain metastasis (BM), including 6 patients with confirmed partial response (PR).
The antitumor activity was durable. As of the data-cut-off (DCO) date, median duration of response (DoR) had not been reached, with 81.3% of patients remaining on ZEGFROVY treatment. The estimated 6-month durable response rate was 87.5%.
Progression-free survival (PFS) was not mature. The estimated 9-month PFS rate was 83.9%.
The safety profile was consistent with previous studies of ZEGFROVY. No new safety signals were observed.
Dr. Xiaolin Zhang, CEO of Dizal, said: "NSCLC patients with EGFR PACC and other uncommon mutations represent a population with substantial unmet medical need, given the limited availability of effective and well-tolerated target therapies, compared to those available for classical EGFR mutations. The data presented at ELCC further reinforces the potential of ZEGFROVY to address this gap. We are committed to advancing our clinical development programs, with the goal of bringing transformative treatment options to the global lung cancer community as quickly as possible."
ZEGFROVY is approved in the U.S. and China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins. Recently, Dizal reported the results from the randomized Phase 3 WU-KONG28 study, comparing ZEGFROVY monotherapy with platinum containing chemo doublet. ZEGFROVY showed a statistically significant and clinically meaningful improvement in PFS in newly diagnosed patients with EGFR exon20ins. Detailed results will be presented at the upcoming scientific conference.
About ZEGFROVY(sunvozertinib)
ZEGFROVY is an irreversible EGFR inhibitor discovered by Dizal scientists targeting a wide spectrum of EGFR mutations with wild-type EGFR selectivity. ZEGFROVY is approved in the U.S. and China for the treatment the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion mutations (exon20ins), whose disease has progressed on or after platinum-based chemotherapy. The approval in China is based on the results of the pivotal WU-KONG6 study in platinum-based chemotherapy pretreated NSCLC with EGFR exon20ins. The U.S. approval is supported by WU-KONG1 Part B, a multinational pivotal study investigating the efficacy and safety of ZEGFROVY in the same indication.
In addition, ZEGFROVY also demonstrated encouraging anti-tumor activity in NSCLC patients with EGFR sensitizing, T790M, and uncommon mutations, as well as HER2 exon20ins.
ZEGFROVY showed a well-tolerated and manageable safety profile in the clinic. The most common drug-related TEAEs (treatment-emergent adverse event) were Grade 1/2 in nature and clinically manageable.
WU-KONG28, a multinational, randomized Phase 3 study conducted across 16 countries and regions evaluating ZEGFROVY as first-line treatment for patients with EGFR exon20ins NSCLC, met its primary endpoint.
Pre-clinical and clinical results of ZEGFROVY were published in peer-reviewed journals Cancer Discovery, The Lancet Respiratory Medicine and Journal of Clinical Oncology.
(Press release, Dizal Pharma, MAR 27, 2026, View Source [SID1234663985])