Topline Results from Pivotal Studies of Sunvozertinib and Golidocitinib Selected for Oral Presentations

SHANGHAI, April 27, 2023 /PRNewswire/ -- Dizal today announced that multiple clinical data of its two leading assets – sunvozertinib and golidocitinib have been selected for presentations at the 2023 ASCO, June 2-6, 2023 in Chicago. A total of four abstracts will be presented, including two oral presentations and two poster presentations.

Sunvozertinib (DZD9008), which was granted Breakthrough Therapy Designation by both the US FDA and China NMPA, is a rationally designed, oral, best-in-class tyrosine kinase inhibitors (TKI) specifically designed to selectively target epidermal growth factor receptor (EGFR) exon 20 insertions (Exon20ins) mutations. The China NMPA has accepted new drug application (NDA) and granted priority review for sunvozertinib for the treatment of advanced non-small cell lung cancer (NSCLC) with EGFR Exon20ins mutations after platinum-based chemotherapies. Dizal will present the updated results of WU-KONG6, the pivotal study of sunvozertinib in ≥ second line setting in an oral session at 2023 ASCO. In addition, two other abstracts selected for poster presentations include the preliminary results of sunvozertinib in the treatment-naive EGFR Exon20ins NSCLC and anti-tumor activity of sunvozertinib in NSCLC patients with EGFR sensitizing mutations after failure of EGFR TKI treatment.

Golidocitinib (DZD4205) is an oral, highly selective Janus kinase 1 (JAK1) inhibitor currently being evaluated in a multinational, pivotal study in relapsed or refractory peripheral T-cell lymphoma (r/r PTCL), which was granted Fast Track Designation by the US FDA in 2022. The clinical data from phase I/II study of golidocitinib in patients with r/r PTCL shows good safety and promising anti-tumor efficacy, which have been selected for oral presentations at multiple authoritative scientific conferences for three consecutive years (2023 ASCO, 2022 EHA, 2021 ICML and 2021 CSCO). At 2023 ASCO, Dizal will present the multinational pivotal study results orally for the first time.

*Note: 1. ASCO = American Society of Clinical Oncology; 2. ESMO = European Society for Medical Oncology; 3. EHA = The European Hematology Association; 4. ICML = International Conference on Malignant Lymphoma Lugano; 5. CSCO = Chinese Society of Clinical Oncology

Dizal's Presentations at 2023 ASCO

About sunvozertinib (DZD9008)

Sunvozertinib was designed with the goal to address the limitations of existing NSCLC therapies. It is a rationally designed, irreversible EGFR inhibitor targeting various EGFR mutations with wild-type EGFR selectivity. The first pivotal study WU-KONG6 of sunvozertinib has achieved its primary endpoint, demonstrating superior antitumor efficacy in pre-treated NSCLC patients with EGFR Exon20ins mutations. The confirmed objective response (cORR) at 300 mg was 59.8% by Blinded Independent Central Review (BICR). In patients with pre-treated, stable and asymptomatic brain metastasis, the cORR was 48.4%. (Data cut-off date: July 31, 2022). Preliminary efficacy of sunvozertinib has also been observed in NSCLC with EGFR sensitizing mutations, T790M mutations, other EGFR mutation subtypes (such as G719X, L861Q, etc.), and HER2 exon20ins mutations.

It is well tolerated with a manageable AE profile. Global pivotal studies are ongoing for ≥ 2nd line and 1st line treatment of NSCLC with EGFR Exon20ins mutation. Pre-clinical and clinical Results of sunvozertinib were published in peer-reviewed journal of Cancer Discovery (IF:39.397) in Apr 2022. The China NMPA has accepted NDA and granted priority review for sunvozertinib for the treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum-based chemotherapies.

About Golidocitinib (DZD4205)

Golidocitinib (DZD4205), which was granted Fast Track Designation by US FDA, is an oral, potent, JAK1 specific inhibitor. The results from the phase I/II trial, which is evaluating the efficacy and safety of golidocitinib in patients with r/r PTCL, showed golidocitinib yielded an ORR of 42.9% (Data cut-off date: May 31, 2021). The agent is currently being studied in the global pivotal study for the treatment of r/r PTCL.

About Dizal

Dizal is a clinical-stage, biopharmaceutical company, dedicated to the discovery and development of differentiated therapeutics for the treatment of cancer and immunological diseases. Deep-rooted in translational science and molecular design, it has established an internationally competitive portfolio of five clinical-stage assets with two leading assets in global pivotal studies.

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