On April 26, 2023 Dizal reported that multiple clinical data of its two leading assets – sunvozertinib and golidocitinib have been selected for presentations at the 2023 ASCO (Free ASCO Whitepaper), June 2-6, 2023 in Chicago (Press release, Dizal Pharma, APR 26, 2023, View Source [SID1234630561]). A total of four abstracts will be presented, including two oral presentations and two poster presentations.
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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 (Free ASCO Whitepaper). 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 (Free ASCO Whitepaper), 2022 EHA (Free EHA Whitepaper), 2021 ICML and 2021 CSCO). At 2023 ASCO (Free ASCO Whitepaper), Dizal will present the multinational pivotal study results orally for the first time.
*Note: 1. ASCO (Free ASCO Whitepaper) = American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper); 2. ESMO (Free ESMO Whitepaper) = European Society for Medical Oncology; 3. EHA (Free EHA Whitepaper) = The European Hematology Association (EHA) (Free EHA Whitepaper); 4. ICML = International Conference on Malignant Lymphoma Lugano; 5. CSCO = Chinese Society of Clinical Oncology
Dizal’s Presentations at 2023 ASCO (Free ASCO Whitepaper)
Lead Author
Abstract Title
Presentation Details
Prof. Mengzhao
Wang
Sunvozertinib for the
treatment of NSCLC with
EGFR Exon20 insertion
mutations: The first pivotal
study results
Abstract #9002
Session Type: Oral
Oral Abstract Session
Lung Cancer – Non-Small Cell Metastatic
Session
Date and Time: June 6, 2023, 09:45 AM-12:45
PM CDT
Prof. Qingqing
Cai
Golidocitinib in treating
refractory or relapsed
peripheral T-cell
lymphoma: Primary
analysis of the
multinational pivotal study
results (JACKPOT8)
Abstract #7503
Session Type: Oral
Oral Abstract Session
Hematologic Malignancies – Lymphoma and Chronic Lymphocytic Leukemia
Session
Date and Time: June 6, 2023, 09:45 AM-12:45
PM CDT
Prof. Yan Xu
Efficacy and safety of
sunvozertinib in treatment
naïve NSCLC patients with
EGFR exon20 insertion
mutations
Abstract #9073
Poster Session
Lung Cancer – Non-Small Cell Metastatic
Session
Date and Time: June 4, 2023, 08:00 AM-11:00
AM CDT
Prof. James
Chih-Hsin Yang
Anti-tumor activity of
sunvozertinib in NSCLC
with EGFR sensitizing
mutations after failure of
EGFR TKI treatment
Abstract #9103
Poster Session
Lung Cancer – Non-Small Cell Metastatic
Session
Date and Time: June 4, 2023, 08:00 AM-11:00
AM CDT
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.