Results of subgroup analysis from the pivotal WU-KONG1B study
in relapsed or refractory NSCLC with EGFR exon20ins presented at
ESMO 2024
- Sunvozertinib demonstrated promising anti-tumor efficacy,
regardless of EGFR exon20ins region classification, race, region,
baseline brain metastasis, prior amivantamab or prior immunotherapy
status.
- The safety profile of sunvozertinib was similar to
previously reported results, and clinically manageable.
SHANGHAI, Sept. 17,
2024 /PRNewswire/ -- Dizal (SSE:688192), a
biopharmaceutical company committed to developing novel medicines
for the treatment of cancer and immunological
diseases, presented subgroup analysis findings of its WU-KONG1
Part B (WU-KONG1B) study at the 2024 European Society for
Medical Oncology (ESMO) Congress. The results showed promising
anti-tumor efficacy of sunvozertinib in relapsed or refractory
non-small cell lung cancer (NSCLC) with epidermal growth factor
receptor (EGFR) exon 20 insertion mutations (exon20ins) across
different baseline characteristics, underpinning its significant
clinical value for this patient population around the globe.
WU-KONG1B is an open-label, multinational pivotal study to
investigate the efficacy and safety of sunvozertinib in relapsed or
refractory NSCLC with EGFR exon20ins. The study is currently being
conducted across 10 countries and regions in Asia, Europe,
North America, and South America.
WU-KONG1B met its primary endpoint, with the preliminary results
featured as an oral presentation at the 2024 American Society of
Clinical Oncology (ASCO) Annual Meeting, demonstrating the
transformative potential of sunvozertinib as a single, oral agent
to treat EGFR exon20ins NSCLC. Results of the subgroup analysis
were presented on September 14 at the
2024 ESMO Congress in Barcelona,
Spain.
As of March 22, 2024, a total of
107 patients with at least 33 EGFR exon20ins subtypes were included
in the efficacy analysis set. The key findings were as
follows:
- Per independent review committee (IRC) assessment, target
lesions shrinkage was observed in 92.4% (98/106) of patients.
- Per IRC assessment, the best objective response rate
(ORR) was 53.3%, including 3 complete response (CR).
- By EGFR exon20ins
region classification, the best ORR in near loop, far loop, C-helix
and unknown were 51.9%, 59.1%, 66.7% and 40%, respectively.
- IRC assessed ORR was
comparable between different subgroups regardless of race, region,
baseline disease characteristics and prior anti-cancer treatment
history.
|
Race
|
Region
|
Baseline BM
|
Best Response, n (%)
|
Asian
(n = 62)
|
Non-Asian
(n = 45)
|
Asia
(n = 58)
|
Non-Asia
(n = 49)
|
With
(n = 27)
|
Without
(n = 80)
|
CR
|
3 (4.8)
|
0 (0.0)
|
3 (5.2)
|
0 (0.0)
|
0 (0.0)
|
3 (3.8)
|
PR
|
32 (51.6)
|
22 (48.9)
|
29 (50.0)
|
25 (51.0)
|
18 (66.7)
|
36 (45.0)
|
|
Prior Amivantamab treatment
|
Prior IO treatment
|
Best Response, n (%)
|
With
(n = 14)
|
Without
(n = 93)
|
With
(n = 52)
|
Without
(n = 55)
|
CR
|
0 (0.0)
|
3 (3.2)
|
2 (3.8)
|
1 (1.8)
|
PR
|
7 (50.0)
|
47 (50.5)
|
26 (50.0)
|
28 (50.9)
|
- With median follow-up of 7 months, duration of response (DoR)
was not reached, and 66.7% of responders were still
responding.
- The safety profile was similar to previously reported results,
and clinically manageable.
"WU-KONG1B study enrolled more than 40% of non-Asian patients.
The subgroup analysis suggested superior anti-tumor efficacies and
well-tolerated safety profiles of sunvozertinib across EGFR
exon20ins NSCLC patients with different baseline demographics and
clinical characteristics on a global scale. We are intensifying our
efforts to advance ongoing global pivotal studies and regulatory
submissions of this FDA Breakthrough Therapy Designated asset,
making available an effective and safe oral option to more patients
around the world." said Xiaolin
Zhang, PhD, CEO of Dizal.
WU-KONG28, a phase Ⅲ multinational randomized study, is ongoing
to assess sunvozertinib versus platinum-based doublet chemotherapy
as a first-line treatment in patients from 16 countries and regions
in Asia, Europe, North
America, and South America.
The anticipated data of this study is expected to further improve
outcomes of patients in this realm.
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 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. 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.
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.
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, both of which
have already been launched in China.
To learn more about Dizal, please
visit www.dizalpharma.com, or follow us
on Linkedin or Twitter.
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