- Anittumor efficacy of sunvozertinib was observed in patients
regardless of baseline EGFR exon20ins status in plasma
ctDNA.
- Sunvozertinib could effectively clear EGFR exon20ins in
plasma ctDNA, confirming its direct effect on EGFR
pathway.
- The resistance to sunvozertinib could be through
EGFR-dependent and EGFR-independent mechanisms and combination of
golidocitinib, a JAK1 inhibitor, with chemotherapy could be a
potential approach to overcome sunvozertinib resistance.
SHANGHAI, May 24, 2024
/PRNewswire/ -- Dizal (SSE:688192), a biopharmaceutical company
committed to developing groundbreaking new medicines for the
treatment of cancer and immunological diseases, announced new
findings from a biomarker study in non-small cell lung cancer
(NSCLC) patients with exon 20 insertion (exon20ins) mutations,
highlighting sunvozertinib as an effective treatment for this
patient population. The findings have been published in an abstract
(#8563) available on the official website of the 2024 American
Society of Clinical Oncology's (ASCO) Annual Meeting.
A total of 121 patients with EGFR exon20ins mutations treated
with sunvozertinib were included in this biomarker
study. Serial plasma ctDNA samples were collected from
baseline until disease progression (PD). The key findings of the
analysis were as follows:
Anittumor efficacy of sunvozertinib was observed in patients
regardless of baseline EGFR exon20ins status in plasma
ctDNA.
- There was a positive correlation between detectable EGFR
exon20ins in baseline plasma ctDNA and higher number of metastasis
sites.
- Higher abundance of EGFR exon20ins in baseline plasma
ctDNA was positively correlated with more metastasis sites and
brain metastasis (BM).
- Patients with baseline negative EGFR exon20ins in plasma
ctDNA achieved a higher objective response rate (ORR) (68.0% vs.
45.8%) and longer median progression free survival (PFS) (7.4
months vs. 5.5 months) than those with positive EGFR
exon20ins.
Sunvozertinib could effectively clear EGFR exon20ins
in plasma ctDNA, confirming its direct effect on EGFR
pathway.
- Decrease of EGFR exon20ins mutant allele was observed in
85.7% of patients with sunvozertinib treatment.
- The earliest clearance of EGFR exon20ins occurred after
one week of sunvozertinib treatment.
The resistance to sunvozertinib could be through
EGFR-dependent and EGFR-independent mechanisms and combination of
golidocitinib, a JAK1 inhibitor, with chemotherapy could be a
potential approach to overcome sunvozertinib resistance.
- Acquired EGFR C797S and other genetic aberrations in EGFR
downstream signaling pathway may be associated with resistance to
sunvozertinib.
- In vitro and in vivo experiments suggested
that combination of golidocitinib, a JAK1 inhibitor, with
chemotherapy could be a potential approach to overcome
sunvozertinib resistance.
"This biomarker study selected for poster presentation at 2024
ASCO Annual Meeting helps us further optimize treatment options for
NSCLC patients with EGFR exon20ins mutations, and at the same time
validates sunvozertinib's efficiency of clearance of EGFR exon20ins
mutations." said Xiaolin Zhang, PhD,
CEO of Dizal, "Supported by positive findings from the WU-KONG6
study, a pivotal study with patients from China, sunvozertinib was approved in
China in relapsed or refractory
setting, making it the world's first and only oral drug for the
treatment of NSCLC patients with EGFR exon20ins mutations. The
latest data from WU-KONG1 Part B, the equivalent study with
patients worldwide, will be unveiled at the upcoming ASCO meeting.
The study met its predefined primary end point and was
statistically significant, providing substantial evidence for
successful NDA submissions of sunvozertinib in the US, the EU and
other overseas markets."
WU-KONG1 Part B is a multinational pivotal study, currently
being conducted across ten countries and regions in Asia, Europe,
North America, and South America. The primary analysis showed
that sunvozertinib demonstrated promising antitumor efficacy in
relapsed or refractory NSCLC with EGFR exon20ins, with a tolerable
safety profile. The updated data will be presented orally at the
2024 ASCO Annual Meeting (Abstract #8513).
- End -
About sunvozertinib (DZD9008)
Sunvozertinib is an irreversible EGFR inhibitor discovered by
Dizal scientists targeting a wide spectrum of EGFR mutations with
wild-type EGFR selectivity. In August
2023, sunvozertinib received approval from NMPA to treat
advanced NSCLC with EGFR exon20ins mutations after platinum-based
chemotherapies. The approval is based on the results of WU-KONG6
study, the pivotal study of sunvozertinib in platinum-based
chemotherapy pretreated NSCLC with EGFR exon20ins mutations. The
primary endpoint of the study was the confirmed overall response
rate (cORR) as assessed by the Independent Review Committee (IRC)
reached 60.8%. Anti-tumor efficacy was observed across a broad
range of EGFR exon20ins subtypes, and in patients with pretreated
and stable brain metastasis. In addition, sunvozertinib also
demonstrated encouraging anti-tumor activity in NSCLC patients with
EGFR sensitizing, T790M, and uncommon mutations (such as G719X,
L861Q, etc.), as well as HER2 exon20ins mutations.
Sunvozertinib showed a well-tolerated and manageable safety
profile in the clinic. The most common drug-related TEAEs
(treatment-emergent adverse event) were Grade 1/2 in nature and
clinically manageable.
Two global pivotal studies are ongoing in ≥ 2nd line (WU-KONG1
Part B) and 1st line setting (WU-KONG28), respectively, in NSCLC
patients with EGFR exon20ins mutations.
Pre-clinical and clinical results of sunvozertinib were
published in peer-reviewed journals Cancer
Discovery (IF:39.397) and The Lancet Respiratory
Medicine (IF: 76.2).
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 two leading assets in global pivotal studies and one already
launched.
To learn more about Dizal, please
visit www.dizalpharma.com, or follow us
on Linkedin or Twitter.
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may differ materially from information contained in the
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to be incorrect.
Contacts
Investor Relations: ir@dizalpharma.com
Business Development: bd@dizalpharma.com
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