Dizal's Oncology Pipeline Continues to Impress with Two Oral Presentations at 2023 ASCO Annual Meeting

SHANGHAI, May 25, 2023 /PRNewswire/ -- Dizal (688192.SH) today announced that data from its oncology portfolio will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, June 2-6, 2023 in Chicago. The data which include updated analyses of Dizal's two leading assets – sunvozertinib (a selective EGFR TKI targeting a wide spectrum of EGFR mutations) and golidocitinib (a highly selective JAK1 inhibitor), underscore Dizal's dedication to developing and delivering innovative medicines that will make a meaningful difference to people living with cancer.

Presentation Highlights

Sunvozertinib

Dizal will present updated results of WU-KONG6, the pivotal study of sunvozertinib in platinum-based chemotherapy pretreated NSCLC with EGFR Exon20ins mutations in an oral session.

Patients treated with sunvozertinib (n = 97) achieved a confirmed objective response rate (cORR) of 60.8% assessed by independent review committee (IRC). Anti-tumor efficacy was observed across a broad range of EGFR Exon20ins subtypes, and tumor response was also observed in patients with pretreated and stable brain metastasis. Sunvozertinib showed significant anti-tumor efficacy and well tolerated safety profiles. These data suggest that sunvozertinib could be an effective and safe treatment option for this unmet medical need.

Golidocitinib

The clinical data of JACKPOT8 Part B, a multinational pivotal study of golidocitinib in relapsed or refractory peripheral T-cell lymphoma (r/r PTCL) will make its debut at the meeting.

PTCL is a group of heterogenous and rare non-Hodgkin lymphoma originating from mature T cells. There is no consensus on the standard treatment for r/r PTCL. Golidocitinib demonstrated promising and durable anti-tumor efficacy, making it a superior treatment option to fight against this devastating disease. This data was also accepted as an encore presentation at the 17^th International Conference on Malignant Lymphoma Lugano (ICML) and will be presented orally.

In addition, two abstracts about sunvozertinib in the first line setting and heavily pretreated EGFR mutant NSCLC, respectively, were selected as poster presentations in ASCO 2023 annual meeting, including:

• The "best-in-class" potential of sunvozertinib as a first line treatment for NSCLC patients with EGFR Exon20ins mutations.
• Promising anti-tumor efficacy of sunvozertinib with median PFS of close to 6 months in heavily pretreated NSCLC patients with EGFR sensitizing mutations who failed standard EGFR TKI treatment (median 5 lines of prior therapies).

The updated data will be presented at the meeting.

"We are thrilled to have a robust presence at this year's ASCO meeting, showcasing our strong portfolio and rapid acceleration of our pipeline in oncology and hematological malignancies."  said Xiaolin Zhang, Ph.D., Chairman and CEO of Dizal, "Sunvozertinib has further reinforced its best-in-class position with an even higher ORR, while golidocitinib will debut its global pivotal study results, demonstrating its superior efficacy. These presentations reflect the high quality of our science and our unwavering commitment to advance cancer research and improve patient outcomes."

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Select studies, along with the dates, times and locations of their data sessions, are highlighted below.

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, 10:09 AM-10:21AM CDT Venue: Hall D1
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, 10:45 AM-10:57 AM CDT Venue: S100a
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 Venue: Hall A
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 Venue: Hall A

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 objective, demonstrating superior anti-tumor efficacy in pretreated NSCLC patients with EGFR Exon20ins. The confirmed objective response rate (cORR) at 300 mg was 60.8% assessed by IRC (Data cut-off date: October 17, 2022). 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. Two multinational pivotal studies are ongoing in ≥ 2^nd line (WU-KONG1) and 1^st line settings (WU-KONG28), respectively, in NSCLC patients with EGFR Exon20ins mutations.

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Pre-clinical and Phase 1 clinical results of sunvozertinib were published in peer-reviewed journal Cancer Discovery (IF:39.397) in April 2022. The China NMPA has accepted NDA filing and granted priority review for sunvozertinib for the treatment of advanced NSCLC with EGFR Exon20ins mutations after platinum-based chemotherapy.

About Golidocitinib (DZD4205)

Golidocitinib (DZD4205) is an oral, potent, JAK1 selective inhibitor. It is the first JAK inhibitor which has moved into the stage of pivotal clinical development. In phase 1 study (Data cut-off date: May 31, 2021), golidocitinib showed encouraging anti-tumor activity in patients with r/r PTCL, with an ORR of 42.9%, and among those responders, more than 50% achieved complete response. The longest duration of response was longer than 14 months.

Golidocitinib was granted Fast Track Designation by US FDA in February 2022.

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. To learn more about Dizal, please visit dizalpharma.com, or follow us on LinkedIn and Twitter.

Forward-Looking Statements

This news release may contain certain forward-looking statements that are, by their nature, subject to significant risks and uncertainties. The words "anticipate", "believe", "estimate", "expect", and "intend" and similar expressions, as they relate to Dizal, are intended to identify certain forward-looking statements. Dizal does not intend to update these forward-looking statements regularly.

These forward-looking statements are based on the existing beliefs, assumptions, expectations, estimates, projections, and understandings of the management of Dizal with respect to future events at the time these statements are made. These statements are not a guarantee of future developments and are subject to risks, uncertainties, and other factors, some of which are beyond Dizal's control and are difficult to predict. Consequently, actual results may differ materially from information contained in the forward-looking statements as a result of future changes or developments in our business, Dizal's competitive environment, and political, economic, legal, and social conditions.

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SOURCE Dizal Pharmaceutical

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