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 -- 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) studyat 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).

ByEGFR 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,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,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 journalsCancer 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 havealready been launched in China.

To learn more about Dizal,please visitwww.dizalpharma.com,or follow us onLinkedinorTwitter.

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