Dizal's Sunvozertinib Approved by China NMPA with Potential for Best-in-class Therapy in NSCLC with EGFR Exon20ins Mutations

• Sunvozertinib, a selective EGFR TKI targeting a wide spectrum of EGFR mutations, is the first Chinese Innovative drug approved for NSCLC Patients with EGFR Exon20ins
• Approval based on the results of primary endpoint from WU-KONG6 study, which demonstrated a superior confirmed objective response rate (cORR) of 60.8%

SHANGHAI, Aug. 23, 2023 /PRNewswire/ -- Dizal today announced that sunvozertinib has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 20 insertion  (Exon20ins) mutations, whose disease has progressed on or after platinum-based chemotherapy. Sunvozertinib, with its superior efficacy and safety profile, is the first and only Category-I Innovative Drug in China for the treatment of lung cancer that has been granted breakthrough therapy designations from both the NMPA and the FDA.

Sunvozertinib cemented "best-in-class" position due to its superior efficacy and safety profile.

Non-small cell lung cancer (NSCLC) is the most common type of cancer in China, with the highest incidence and mortality rates. EGFR is the most common driver gene mutation in NSCLC, and the EGFR Exon20ins mutation is the most prevalent rare type, accounting for approximately 12% of all EGFR mutations. However, due to its unique spatial configuration and high heterogeneity, there has been a persistent lack of safe and effective targeted treatment options for this mutation. Consequently, patients with EGFR Exon20ins mutation have experienced limited survival benefits, highlighting the urgent clinical need to address this challenge.

The NMPA approval is based on the results from WU-KONG6, the pivotal study of sunvozertinib in platinum-pretreated NSCLC patients with EGFR Exon20ins mutations conducted in China.  Topline readouts were presented in an oral session at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting.

Among 97 patients treated with the recommended phase II dose (RP2D) of 300mg QD:

• The study's primary endpoint, cORR achieved 60.8%, indicating a significant improvement compared to current treatment options.
• The overall safety is similar to other EGFR TKIs and clinically manageable, demonstrating a benign safety profile.

Commenting on the approval, Prof. Mengzhao Wang, MD, PhD at Peking Union Medical College Hospital, the leading principal investigator of WU-KONG6, said, "In pre-treated advanced NSCLC patients with EGFR Exon20ins mutations, monotherapy with sunvozertinib achieved a remarkable ORR of 60.8%. This treatment demonstrated comparable efficacy to traditional EGFR TKIs in treating pre-treated advanced NSCLC patients with EGFR sensitizing mutations. The approval of sunvozertinib is expected to change the current treatment dilemma for patients with EGFR Exon20ins mutant advanced NSCLC, providing them with more effective and safer treatment options."

"Sunvozertinib represents a groundbreaking achievement as the first Chinese innovative drug approved for EGFR Exon20ins NSCLC, showcasing Dizal's remarkable efficiency and unwavering commitment to innovation," said Xiaolin Zhang, PhD, Chairman and CEO of Dizal, "Our achievement of obtaining NDA approval in less than four years from enrolling the first patient sets an unprecedented benchmark for the rapid development of targeted lung cancer treatments. We are thrilled to bring sunvozertinib, the potentially best-in-class targeted therapy, to patients in China. Furthermore, the commercial launch of sunvozertinib represents a significant milestone for Dizal, underscoring our capabilities from research and development to commercialization. Moving forward, we will accelerate our efforts to achieve profitability and ensure the rapid accessibility of Dizal's innovative therapies to patients in China and worldwide."

Dizal is rapidly advancing global pivotal studies in EGFR-mutated NSCLC realm.

Preclinical studies have provided compelling evidence of sunvozertinib's potent inhibitory effects on different EGFR mutation subtypes, including the difficult-to-treat EGFR Exon20ins mutations, while maintaining selectivity against wild-type EGFR. These findings establish a strong scientific foundation for the therapeutic potential of sunvozertinib in the treatment of EGFR-mutated NSCLC.

In the first-line setting of EGFR Exon20ins NSCLC, where effective targeted therapies are currently unavailable, sunvozertinib monotherapy demonstrated significant efficacy in treatment-naive patients. Preliminary results have demonstrated a best objective response rate (BOR) of 77.8% in the 300 mg cohort. To further evaluate the efficacy and safety of sunvozertinib, Dizal is conducting two global studies, known as WU-KONG28 and WU-KONG1 PART B, in both first-line and ≥ second-line treatment of EGFR Exon20ins NSCLC.

For patients with EGFR sensitizing mutations who have failed standard EGFR TKI treatment (median 5 lines of prior treatment), sunvozertinib monotherapy has shown a mPFS of 5.8 months. This promising result offers new hope in overcoming resistance to third-generation EGFR TKI.

Sunvozertinib have consistently been featured at prestigious international academic conferences such as ASCO, WCLC, and ESMO for three consecutive years, showcasing its significance and potential in the field of EGFR-mutated NSCLC. Going forward, Dizal will leverage the approval of sunvozertinib as a catalyst to expedite global access to Chinese innovative drugs. This endeavor will be driven by a strong commitment to original innovation and efficient commercialization.

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 for the treatment of 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. As assessed by the Independent Review Committee (IRC), the primary endpoint of cORR at RP2D of 300mg QD 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 Phase I clinical results of sunvozertinib were published in peer-reviewed journal Cancer Discovery (IF:39.397) in April 2022.

About Dizal

Dizal is a 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 and one already approved.

To learn more about Dizal, please visit www.dizalpharma.com, or follow us at Linkedin or Twitter.

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