Dizal, a biopharmaceutical company committed to developing novel medicines for cancer and immunological diseases, has announced the presentation of new clinical data for Zegfrovy® (sunvozertinib) as a first-line treatment in patients with advanced non-small cell lung cancer (NSCLC) harbouring epidermal growth factor receptor (EGFR) P-Loop and αC-helix compressing (PACC) or other uncommon mutations.
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 tumours.
At the recommended phase 3 dose (RP3D) of 300 mg, Zegfrovy monotherapy demonstrated promising antitumour activity and a manageable safety profile in treatment-naïve patients with advanced NSCLC harbouring EGFR PACC or other uncommon mutations.
- Per investigator assessment, tumour 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%.
- Tumour 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 nine-month PFS rate was 83.9%.
- The safety profile was consistent with previous studies of ZEGFROVY. No new safety signals were observed.
Zegfrovy is approved in the US and China for the treatment of relapsed or refractory NSCLC with EGFR exon20ins.
Recently, Dizal reported the results from the randomised 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.
