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Research Outcomes of Prof. Wang Mengzhao’s Team on Chinese Innovative Drug Published in Top International Journal
CopyFrom: PUMCH UpdateTime: 2022-06-23 Hits: 12 Font Size: SmallBig

Recently, breakthrough results of a domestic multi-center clinical study led by Professor Wang Mengzhao, Director of the Department of Pulmonary and Critical Care of PUMCH, and of an international multi-center clinical study led by Professor Pasi A. Jänne, from the Dana-Farber Cancer Institute affiliated with Harvard Medical School, and Professor Yang Zhixin, from National Taiwan University Cancer Center, was published in full text online in the top international journal “Cancer Discovery” (IF 39.397). Applying Chinese innovative drug Sunvozertinib, these studies bring new hope to patients with advanced non-small cell lung cancer carrying mutations. Up to now, this is the first and the only Chinese innovative drug in the field of lung cancer treatment that has been granted “Breakthrough Therapy Designation (BTD)” by both China and the United States.

Lung cancer is the cancer with the highest morbidity and mortality in China, and about 85% of lung cancer patients suffer the non-small cell type. Epidermal growth factor receptor (EGFR) exon 20 insertion mutation (Exon20ins) is the most common type of non-classic mutations and account for 4%-12% of all EGFR mutations in non-small cell lung cancer (NSCLC) patients. This population of patients cannot be ignored. The currently approved EGFR Tyrosine kinase inhibitors (TKIs) have poor efficacy.

To crack this hard nut, since 2019, Professor Wang Mengzhao has led the domestic phase I multi-center study (WU-KONG2 study) of Sunvozertinib, a Chinese Class I innovative drug, to evaluate its safety, resistance, pharmacokinetics and preliminary antitumor activity. At the same time, the international phase I multi-center clinical study (WU-KONG1 study) was also carried out simultaneously. Thanks to the efficient and professional support of the Clinical Pharmacology Center of PUMCH, and the joint efforts of 8 research centers across the country, the WU-KONG2 study, though launched half a year later, was completed successfully earlier than the WU-KONG1 study.

A total of 102 patients with EGFR-mutant or HER2-mutant locally advanced or metastatic NSCLC whose systemic therapy failed were enrolled and treated with Sunvozertinib as an orally administered monotherapy. Among them, 56 patients with the EGFR exon20ins mutation were included in the efficacy analysis. The results of the study suggest that Sunvozertinib is effective for patients with different subtypes of the EGFR exon20ins mutation, and the overall population objective response rate (ORR) is 41.1%. The ORR of the group with the recommended dosage of 300 mg in the phase II study is 48.4%.

In addition, this study also observed the anti-tumor activity of Sunvozertinib against EGFR-sensitive mutations, EGFR T790M mutations and rare EGFR mutations, and the scope of clinical application is being further explored.

At present, PUMCH is once again leading the phase II multi-center registry study of Sunvozertinib in China. Professor Wang Mengzhao continues to lead investigators from 37 hospitals across the country to further evaluate the efficacy of Sunvozertinib for locally advanced or metastatic NSCLC patients with the EGFR exon20ins mutation.

Written by: Xu Yan from the Department of Pulmonary and Critical Care

Translator: Liu Haiyan

Editor: Tian Xinlun and Wang Yao