DZD6008 / Dizal Pharmaceutical - LARVOL DELTA

Phase I/II study of DZD6008, a 4th-generation EGFR TKI with full BBB penetration, in EGFR-mutant NSCLC. (ASCO 2025) - "In osimertinib-resistant CDX and PDX models carrying EGFR triple mutations, DZD6008 induced profound tumor shrinkage in a dose-dependent manner. DZD6008 is a novel, highly selective, full-BBB penetrant EGFR TKI with broad-spectrum of activity against different EGFR mutations. In heavily pre-treated EGFRm NSCLC patients, DZD6008 monotherapy was well-tolerated and showed encouraging anti-tumor activity. TIAN-SHAN2 study is ongoing and updated data will be presented at the meeting."

P1/2 data • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DZD6008, a fourth-generation EGFR TKI, in pretreated NSCLC patients with EGFR C797X mutations: Results from phase 1/2 studies. (ASCO 2026) - P1 | "DZD6008 demonstrated promising and durable anti-tumor activity in patients with EGFR C797X+ NSCLC with a manageable safety profile, supporting its potential use as a later line treatment option after 3rd generation EGFR TKI failure. The updated data will be presented at the meeting."

Clinical • P1/2 data • Hematological Disorders • Lung Cancer • Non Small Cell Lung Cancer • Solid Tumor

Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8) (clinicaltrials.gov) - P1/2 | N=220 | Recruiting | Sponsor: Dizal Pharmaceuticals | N=160 ➔ 220

Enrollment change • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7) (clinicaltrials.gov) - P1/2 | N=180 | Recruiting | Sponsor: Dizal Pharmaceuticals | N=100 ➔ 180

Enrollment change • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2) (clinicaltrials.gov) - P1 | N=300 | Recruiting | Sponsor: Dizal Pharmaceuticals | N=190 ➔ 300 | Trial completion date: Jul 2028 ➔ Dec 2028 | Trial primary completion date: Dec 2026 ➔ Oct 2027

Enrollment change • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8) (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Trial completion date: Dec 2029 ➔ Dec 2028 | Trial primary completion date: Dec 2028 ➔ Jun 2028

Trial completion date • Trial primary completion date • Lung Cancer • Lung Non-Squamous Non-Small Cell Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Dizal to Report Key Progress in its NSCLC Portfolio with Two Oral Presentations and a Poster During ASCO 2026 (PRNewswire) - "Results from the multinational Phase 3 WU-KONG28 study of ZEGFROVY have been selected for oral presentation as an LBA...Updated clinical data of DZD6008 in pretreated NSCLC patients with EGFR C797X mutations have also been selected for oral presentation...In addition, Dizal will present the latest findings from a study evaluating golidocitinib in combination with anti–PD-1 antibody in NSCLC without known driver mutations."

EGFR exon 20 • Late-breaking abstract • P1 data • P2 data • P3 data • Non Small Cell Lung Cancer

A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1) (clinicaltrials.gov) - P1 | N=140 | Recruiting | Sponsor: Dizal Pharmaceuticals | N=70 ➔ 140

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1) (clinicaltrials.gov) - P1 | N=70 | Recruiting | Sponsor: Dizal Pharmaceuticals | N=48 ➔ 70

Enrollment change • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2) (clinicaltrials.gov) - P1 | N=190 | Recruiting | Sponsor: Dizal Pharmaceuticals | N=76 ➔ 190 | Trial completion date: Jun 2027 ➔ Jul 2028 | Trial primary completion date: Apr 2026 ➔ Dec 2026

Enrollment change • Trial completion date • Trial primary completion date • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8) (clinicaltrials.gov) - P1/2 | N=200 | Recruiting | Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7) (clinicaltrials.gov) - P1/2 | N=100 | Recruiting | Sponsor: Dizal Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1) (clinicaltrials.gov) - P1 | N=48 | Recruiting | Sponsor: Dizal Pharmaceuticals | Not yet recruiting ➔ Recruiting

Enrollment open • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Study of Oral EGFR Inhibitor DZD6008 Combined With Sunvozertinib in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN8) (clinicaltrials.gov) - P1/2 | N=200 | Not yet recruiting | Sponsor: Dizal (Jiangsu) Pharmaceutical Co., Ltd.

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DZD6008 Combination Therapy in Patients With Locally Advanced or Metastatic NSCLC With EGFR Mutation (TIAN-SHAN7) (clinicaltrials.gov) - P1/2 | N=100 | Not yet recruiting | Sponsor: Dizal Pharmaceuticals

New P1/2 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

DZD6008: A 4th generation EGFR TKI Poised to Address Unmet Needs in NSCLC (ACROFAN) - P1 | N=76 | TIAN-SHAN2 (NCT06813365) | Sponsor: Dizal Pharmaceuticals | "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."

P1 data • Preclinical • Non Small Cell Lung Cancer

Dizal to Showcase Data in Hematologic Malignancies and Lung Cancer at ASCO 2025 (PRNewswire) - "DZD8586 study results in B-cell non-Hodgkin lymphomas (B-NHLs) were selected for oral and poster presentations. The analysis in chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) after covalent or non-covalent BTK inhibitors and BTK degraders was selected for oral presentation; Dizal will also present results from the ongoing Phase I/II study of DZD6008, a 4th generation EGFR TKI with full BBB penetration, in advanced EGFR mutation positive (EGFRm) non-small cell lung cancer (NSCLC)."

Clinical data • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Non Small Cell Lung Cancer • Small Lymphocytic Lymphoma

A Multinational Study Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN1) (clinicaltrials.gov) - P1 | N=48 | Not yet recruiting | Sponsor: Dizal Pharmaceuticals

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor

Dizal Announces DZD8586 and DZD6008 Presentations at 2025 ASCO Annual Meeting (PRNewswire) - "Dizal...announced today that results of its investigational drug candidates DZD8586 and DZD6008, have been selected for presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 – June 3, 2025, in Chicago. Oral and poster presentations of its DZD8586 study results in chronic lymphocytic leukemia (CLL) and diffuse large B-cell lymphoma (DLBCL) are selected by ASCO Scientific Program Committee. In addition, Dizal will present its 4th generation EGFR TKI clinical data in non-small cell lung cancer (NSCLC) during the conference."

Clinical data • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Non Small Cell Lung Cancer

Assessing an Oral EGFR Inhibitor, DZD6008 in Patients Who Have Advanced NSCLC With EGFR Mutations (TIAN-SHAN2) (clinicaltrials.gov) - P1 | N=76 | Recruiting | Sponsor: Dizal Pharmaceuticals

New P1 trial • Lung Cancer • Non Small Cell Lung Cancer • Oncology • Solid Tumor