 |
- Oral presentation of DZD6008 demonstrated strong and durable anti-tumor activity, excellent BBB-penetrant properties, and a favorable safety profile in patients relapsed from third-generation EGFR TKI
- In treatment-naïve patients with advanced NSCLC without driver mutations, Golidocitinib, a JAK-only inhibitor, in combination with anti-PD-1 antibody enhanced anti-tumor response.
SHANGHAI, May 31, 2026 /PRNewswire/ — Dizal (SSE:688192), a biopharmaceutical company committed to developing novel medicines for the treatment of oncology and hematological diseases, today announced the presentations of two studies in non-small cell lung cancer (NSCLC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting. One study evaluated DZD6008, an investigational fourth-generation EGFR TKI, in pre-treated NSCLC patients with EGFR C797X mutations following progression on third-generation EGFR TKI treatment. The results were featured in an oral presentation. The other study reported results for golidocitinib, a JAK1-selective inhibitor, combined with an anti-PD-1 antibody as a first-line treatment for PD-L1-positive, advanced NSCLC without driver mutations.
DZD6008: A Fourth-Generation EGFR TKI Overcomes Resistance Following Third-Generation EGFR TKI Failure
The latest findings showed that DZD6008 demonstrated strong and durable anti-tumor activity in patients relapsed from third-generation EGFR TKI with a favorable safety profile.
- The majority of patients (82.1%) had tumor shrinkage following DZD6008 treatment. Higher response rate is expected with longer treatment.
- Tumor response is durable, with 6 months progression free survival (PFS) rates at 70.6% and 61.8%, respectively for 40 mg and 60 mg cohorts. The median duration of response (DoR) was not reached.
- Excellent blood-brain barrier (BBB) penetration was observed, including strong intracranial anti-tumor activity among patients with baseline brain metastasis.
- DZD6008 demonstrated a favorable safety profile with high selectivity for wild-type EGFR, resulting in minimal adverse effects.
Patients with EGFR-mutant NSCLC whose disease progresses on or after third-generation EGFR TKI treatment often acquire resistance mutations, among which EGFR C797X is one of the most frequently reported. DZD6008 is a fourth-generation EGFR TKI designed with full BBB penetration and high selectivity over wild-type EGFR. Preclinical and clinical data support its potent activities against single, double and triple EGFR mutations (L858R/19del, T790M, C797X).
Golidocitinib: A JAK1 Inhibitor Combined with Anti-PD-1 Demonstrates Durable Clinical Benefit
Among 47 enrolled treatment-naïve patients with advanced NSCLC, golidocitinib plus sintilimab following chemo-immunotherapy demonstrated encouraging and durable anti-tumor efficacy, particularly in those with high PD-L1 expression. Profound improvement of irAE was noticed.
Dr. Xiaolin Zhang, CEO of Dizal, said: “Main reasons for patients relapsed from 3rd generation EGFR TKI treatment include acquired resistance mutations and CNS metastasis. DZD6008 was designed to address these clinical issues. The data presented confirmed that DZD6008 met our design criteria and has the potential to provide an oral safe treatment option for these patients. We are very excited by the clinical data. We look forward to collaborating with investigators worldwide to accelerate its clinical development globally.”
About Golidocitinib (DZD4205)
Golidocitinib is currently the first and only Janus kinase 1 (JAK1) inhibitor being evaluated for the treatment of r/r PTCL. In June 2024, golidocitinib was approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with relapsed or refractory peripheral T-cell lymphoma (r/r PTCL).
At the data cut-off date of August 31, 2023, golidocitinib has demonstrated robust and durable anti-tumor efficacy, with an ORR of 44.3%. All subtypes benefited well, and the ORR of common subtypes exceeded 40%. More than 50% of the patients with tumor remission achieved a complete response with a CRR of 23.9%. Per IRC assessment, the median duration of response (mDoR) reached 20.7 months. As of February 2024, golidocitinib showed a median overall survival (mOS) of 24.3 months.
Golidocitinib was granted Fast Track Designation by the U.S. FDA for the treatment of r/r PTCL in February 2022. In September 2023, the CDE accepted its NDA and granted Priority Review for the treatment of r/r PTCL. The Phase I clinical data of golidocitinib (JACKPOT8 PART A) were published in Annals of Oncology (Impact Factor: 51.8), and global pivotal trial data of golidocitinib for the treatment of r/r PTCL (JACKPOT PART B) were published in The Lancet Oncology (Impact Factor: 54.4).
About DZD6008
DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI, designed as a potential treatment option for advanced EGFR mutation positive (EGFRm) NSCLC.
Non-small cell lung cancer is the leading cause of cancer death in the world. Epidermal growth factor receptor (EGFR) gene is one of the most common driver genes for NSCLC. Multiple agents can be used to treat patients with EGFR mutated NSCLC who develop resistance to EGFR tyrosine kinase inhibitors (TKIs), but the clinical outcome was not satisfactory. Brain metastases (BM) are a leading cause of death and disease progression for NSCLC. Approximately 23%-30% of NSCLC patients are synchronous BM at their initial diagnosis. Previous studies reported that the 3-year cumulative rate of BMs ranges from 29.4% to 60.3% in patients with mutated EGFR.
Currently, the clinical benefits of existing treatments for third-generation EGFR TKI-resistant NSCLC are limited and DZD6008 is expected to fill the unmet medical needs. DZD6008 effectively inhibits EGFR-mutated tumor growth in cell lines and in animal models. Previous clinical studies have validated the design concept of the molecule and suggest that DZD6008 demonstrates good safety and efficacy in NSCLC patients with brain metastases who had failed third-generation EGFR TKI therapy or multiple lines of pre-treatments.
About Dizal
Dizal is a biopharmaceutical company, dedicated to the discovery, development and commercialization of differentiated therapeutics for the treatment of cancer and immunological diseases. The company aims to develop first-in-class and groundbreaking new medicines, and further address unmet medical needs worldwide. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio with multiple assets in global pivotal studies and two leading assets: ZEGFROVY, approved in both the U.S. and China, and golidocitinib, approved in China. To learn more about Dizal, please visit www.dizalpharma.com, or follow us on LinkedIn or X.
Forward-Looking Statements
This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words “anticipate”, “believe”, “estimate”, “expect”, and “intend” and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly.
These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal’s control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal’s competitive environment, and political, economic, legal, and social conditions.
Dizal, the Directors, and the employees of Dizal assume (a) no obligation to correct or update the forward-looking statements contained on this site; and (b) no liability in the event that any of the forward-looking statements does not materialize or turnout to be incorrect.
Contacts
Investor Relations: ir@dizalpharma.com
Business Development: bd@dizalpharma.com
Media Contact: pr@dizalpharma.com
