- DZD8586 demonstrated significant anti-tumor efficacy in heavily pretreated chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) patients with ORR of 84.2%
- DZD6008, a BBB-penetrant 4th generation EGFR TKI, showed encouraging and durable anti-tumor activity with favorable safety and tolerability as a monotherapy in heavily pre-treated non-small cell lung cancer (NSCLC) patients with EGFR-mutations
Dizal, a biopharmaceutical company committed to developing novel medicines for the treatment of cancer and immunological diseases, announced today that it will present latest clinical study results of its investigational drug DZD8586 and DZD6008 at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting. The studies focus on B-cell non-Hodgkin lymphomas (B-NHLs) and non-small cell lung cancer (NSCLC) two disease areas Dizal has approved drugs and strong clinical pipeline.
DZD8586: A Potential Novel Therapeutic Option for Patients with B-NHL
A pooled analysis of two phase I/II studies of DZD8586 in CLL/SLL patients after treatment with covalent or non-covalent BTK inhibitors and BTK degraders (Abstract #7010) was selected for an oral presentation:
- An objective response rate (ORR) of 84.2% was achieved. Tumor response was observed in patients previously treated with BTK inhibitors and BCL-2 inhibitors, with response rates of 82.4% and 83.3%, respectively.
- Tumor response was observed irrespective of prior covalent/non-covalent BTK inhibitor, BTK degrader, or BCL-2 inhibitor treatment, and in patients with classic BTK resistance mutations (C481X) as well as other BTK mutations, including kinase-dead mutations.
- Response was durable, with an estimated 9-month duration of response (DOR) rate of 83.3%.
Prof. Jianyong Li, MD, PhD at Jiangsu Province Hospital, and the leading principal investigator of the study, said, “DZD8586 has shown promising antitumor activity in patients with relapsed/refractory CLL/SLL. By targeting both BTK-dependent and -independent signaling pathways, it could overcome resistance driven by target depletion or bypass activation, addressing significant limitations of current BTK inhibitors. We look forward to continued data readout from ongoing clinical studies.”
In addition, a Phase II study of DZD8586 as monotherapy in relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) (Abstract # e19050) will also be presented at the conference. Patients recruited in the trial had received 1-4 prior lines of therapy, and all were treated with anthracycline-and CD20-antibody based chemoimmunotherapy. At the doses of 50 mg and 75 mg QD, DZD8586 demonstrated promising antitumor activity and a manageable safety profile. Tumor responses were observed in both germinal center B-cell-like (GCB) and non-GCB subtypes. Updated results from this study will be disclosed at the 2025 European Hematology Association (EHA) Annual Congress.
Prof. Lugui Qiu, MD, PhD at Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences, the leading principal investigator of this study, said, “Treatment resistance in relapsed/refractory DLBCL remains a major clinical challenge. DZD8586, a non-covalent dual LYN/BTK inhibitor, has shown activity in both GCB and non-GCG subtypes, an important feature. With full BBB penetration and a favorable safety profile, it also shows promise in patients with CNS involvement, who typically confront a poor prognosis.”
DZD6008: A 4th generation EGFR TKI Poised to Address Unmet Needs in NSCLC
The presentation at ASCO 2025 will feature promising pre-clinical and early clinical data from an ongoing Phase I/II TIAN-SHAN2 study of DZD6008 in patients with EGFRm NSCLC (Abstract #8616). Preclinical studies showed that DZD6008 was potent against EGFR mutations, including single (L858R/19del), double (T790M and L858R/19del), and triple mutations (C797X, T790M and 19del), with good selectivity (> 50-fold) over wild-type EGFR.
As of March 31, 2025, a total of 12 EGFRm NSCLC patients were enrolled in the study during the dose escalation phase. The median number of prior lines of therapy was 4.5 (range 2-8). DZD6008 monotherapy demonstrated encouraging and durable antitumor activity with good tolerability in this heavily pre-treated population. Ten patients (83.3%) showed target lesion shrinkage with DZD6008 treatment. Partial response (PR) was observed at ≥20 mg. In line with preclinical findings, DZD6008 exhibited excellent BBB penetration, as well as sustained efficacy in patients with brain metastases. The ratio of measured free drug concentrations in CSF over plasma is over 1.0.
Prof. Mengzhao Wang, MD, PhD at Peking Union Medical College Hospital, the leading principal investigator of the study said, “DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI with broad-spectrum of activity against different EGFR mutations. The clinical data revealed at ASCO 2025 suggested that DZD6008 has good antitumor activity and tolerability in EGFRm NSCLC patients who were resistant to EGFR TKIs, especially their durable remission effect on metastatic brain lesions. The ongoing TIAN-SHAN2 study aims to further validate these findings in a broader patient population.”
“The clinical data on DZD8586 and DZD6008 presented at this year’s ASCO further highlight our strong R&D capabilities and competitive edge in tackling difficult-to-treat hematologic malignancies and lung cancer. The significant efficacy data and encouraging safety profile give us confidence to push forward to accelerate its clinical development programs,” said Xiaolin Zhang, PhD, CEO of Dizal.
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