The Phase II clinical data of Corning Jerry KN046 combined with chemotherapy in the treatment of advanced non-small cell lung cancer will be announced on ASCO 2021

● KN046 combined with platinum-based chemotherapy shows good tolerability and effectiveness in first-line advanced non-small cell lung cancer; ● The survival rate (OS rate) of 12 months and 15 months is 74.
9%; in PD-L1≥ Similar survival curves were observed in 1% and PD-L1<1% of patients; ● The median progression-free survival (mPFS) of squamous cell carcinoma patients with PD-L1 ≥1% reached 10.
8 months; ● KN046 combined The phase III clinical study of chemotherapy for squamous non-small cell lung cancer is in progress
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June 7, 2021, Suzhou, China-Corning Jereh Biopharmaceuticals (stock code: 9966.
HK) announced that it will announce PD-L1/CTLA in the form of a poster at the 2021 American Society of Clinical Oncology (ASCO 2021) annual meeting -4 Phase II clinical study data of bispecific antibody KN046 combined with platinum-based chemotherapy in the treatment of patients with advanced non-small cell lung cancer (study number: KN046-202)
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The poster was published online on ASCO 2021 on June 4, US Eastern Time.
The electronic poster can be viewed on the company's website
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Subject: KN046 combined with platinum-based chemotherapy in the treatment of patients with advanced non-small cell lung cancer: Phase II, open, multi-center study poster number: 200614 Session title: Lung cancer – No.
1 in metastatic non-small cell lung cancer Author: Professor Yang Yunpeng, Sun Yat-sen University Cancer Center KN046-202 (NCT04054531) is a phase II, open, multi-center clinical study to evaluate the efficacy and safety of KN046 combined with platinum-based chemotherapy in patients with advanced non-small cell lung cancer And tolerability, the results show that KN046 is well tolerated and is effective for the first-line treatment of advanced non-small cell lung cancer; progression-free survival (PFS) and overall survival (OS) benefit, in PD-L1 ≥ 1% and Similar survival curves were observed in patients with PD-L1<1%
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In particular, patients with squamous cell carcinoma with PD-L1≥1% benefit significantly
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As of January 19, 2021, a total of 87 patients with advanced non-small cell lung cancer who have not received systemic treatment were enrolled, including 51 patients with non-squamous cell carcinoma and 36 patients with squamous cell carcinoma
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46 patients had PD-L1≥1%, and 37 patients had PD-L1<1%
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The median treatment time was 21 weeks
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Among 81 patients with evaluable efficacy, the objective response rate (ORR) was 50.
6% (95% CI: 39.
3%, 61.
9%), and the disease control rate (DCR) reached 87.
7% (95% CI: 78.
5%, 93.
9%) )
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In patients with non-squamous non-small cell lung cancer, the objective response rate (ORR) and disease control rate (DCR) were 45.
8% (95% CI: 31.
4%, 60.
8%) and 89.
6% (95% CI: 77.
3%, respectively) 96.
5%); in patients with squamous non-small cell lung cancer, the objective response rate (ORR) and disease control rate (DCR) were 57.
6% (95% CI: 39.
2%, 74.
5%) and 84.
8% (95% CI: 68.
1%, 94.
9)
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The median progression-free survival (mPFS) is 5.
9 months (95% CI: 5.
3, 8.
7), and the median overall survival (OS) has not yet been reached; the survival rates (OS rates) at 12 months and 15 months are both 74.
9%; patients with PD-L1 ≥1% and PD-L1<1% had similar initial OS.
Patients with PD-L1 ≥1% had a median PFS of 6.
7 months, of which PD-L1 ≥1% of squamous cell carcinomas The median PFS of the patients reached 10.
8 months
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In terms of safety, 22 patients (25.
3%) experienced treatment-related adverse events (TRAE) of grade 3 or above, mainly diarrhea (5.
7%), elevated alanine transaminase (4.
6%), and infusion reactions (3.
4 %), skin rash (3.
4%) and elevated aspartate aminotransferase, allergic dermatitis and immune-related pneumonia (both 2.
3%)
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Adverse events are controllable
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The principal investigator of the clinical trial and Professor Zhang Li from Sun Yat-sen University Cancer Hospital said: "Lung cancer is the malignant tumor with the highest incidence and mortality in China.
In recent years, immunotherapy has significantly improved the long-term survival of patients with advanced non-small cell lung cancer.
However, the overall prognosis and long-term efficacy of patients still need to be improved urgently
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We are very pleased to see that Corning Jereh’s bispecific antibody KN046 exhibits advantages such as ORR, PFS and OS in lung cancer patients, which means that patients with advanced NSCLC may gain A better treatment plan
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We look forward to verifying its great value as a first-line treatment in follow-up studies
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" Dr.
Xu Ting, Chairman and President of Corning Jerry, said: "In recent years, immunotherapy has made breakthroughs in the treatment of lung cancer.
Corning Jerry has carried out multiple research projects to explore innovative and better treatment options in the post-PD-1 era
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KN046 Phase II study of the first-line treatment of advanced non-small cell lung cancer is aimed at both patients with squamous cell carcinoma and non-squamous cell carcinoma.
Shows good tolerability, safety and effectiveness
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At present, the phase III clinical study of KN046 combined with chemotherapy in the treatment of squamous non-small cell lung cancer is proceeding smoothly, and it is expected that the first interim analysis data will be seen by the end of this year
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This is the world The first phase III clinical study of the PD-L1/CTLA-4 bispecific antibody.
We hope that the results of this study will change the treatment pattern of advanced non-small cell lung cancer and bring new treatment options to lung cancer patients worldwide
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"About KN046KN046 is a PD-L1/CTLA-4 bispecific antibody independently developed by Corning Jereh.
Its innovative design includes the fusion of CTLA-4 and PD-L1 single-domain antibodies with different mechanisms; it can be enriched in The tumor microenvironment with high PD-L1 expression and the elimination of Tregs that inhibit tumor immunity
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KN046 has been launched in Australia and China to cover more than 10 types of non-small cell lung cancer, triple negative breast cancer, esophageal squamous cell carcinoma, liver cancer, thymic cancer, pancreatic cancer, etc.
There are nearly 20 clinical trials in different stages of cancer, and the trial results show that patients have the advantage of survival benefit
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Based on the clinical trial results obtained in Australia and China, the US FDA approved KN046 to directly enter the phase II clinical trial in the United States, and in September 2020 KN046 month awarded for the treatment of thymic epithelial tumors orphan status
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currently KN046 four pivotal registration clinical trials are underway
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AboutNingjie Rui biopharmaceutical focused on the development, production and commercialization of innovative anticancer drugs
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2019 December 12, the company listed on Hong Kong stock Exchange, stock code: 9966
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Corning Jerry biopharmaceuticals have found the whole industry chain, R & D and manufacturing platform in the bispecific antibody and protein engineering
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the company has a product pipeline includes 15 highly differentiated anti-tumor drug candidates with independent intellectual property rights, mainly double antibodies, and a multifunctional Covid-19 antibody, four of which are in phase I~III in China, the United States, Japan, and Australia Clinical
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The
marketing application of Envolimab Injection (KN035) has been formally accepted by the National Medical Products Administration (NMPA) and included in the priority review
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The company has a number of technical platforms with independent intellectual property rights such as heterodimers and hybrid antibodies, and large-scale production capabilities that meet the cGMP standards of China, the United States and the European Union, and have passed a complete quality system including multiple audits of the European Union QP.

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The company is committed to building an internationally leading, multi-dimensional drug development and industrialization platform, focusing on multifunctional biomacromolecule new drugs, benefiting patients in China and around the world
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Welcome to the company website
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