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        English 中文簡體 中文繁體

        Alphamab Presented Poster Highlighting Clinical Data of KN046 Combined with Chemotherapy as First Line Treatment in Patients with Advanced NSCLC at ESMO 2021

        September 17, 2021 08:15 Eastern Daylight Time

        ●  Here, we report results from a cohort of systemic therapy naive NSCLC pts with resistant oncogenic driver alterations.


        ●  As of January 19, 2021, 12 patients were enrolled. ORR was 50%. DCR was 91.7%. mPFS was 8.7 months. Median overall survival (mOS) was not reached, and OS rate was 100% at 6 months.


        Suzhou, Sep 17, 2021 - Alphamab Oncology (stock code: 9966.HK) announced that data from a Phase II study (KN046-202) of KN046 in combination with Platinum doublet chemotherapy as first-line (1L) treatment in patients with advanced NSCLC harboring resistant oncogenic driver alterations were presented as Poster at the ESMO (European Society for Medical Oncology) congress 2021.


        Topic: KN046 (an anti-PD-L1/CTLA-4 Bispecific Antibody) in combination with Platinum doublet chemotherapy as first-line (1L) treatment in patients with advanced NSCLC harboring resistant oncogenic driver alterations

        Poster number: 1293P

        First author: Professor Wenfeng Fang, PhD, Sun Yat-sen University Cancer Center


        KN046-202 (NCT04054531) is a phase II, open-label, multi-center clinical study to evaluate the efficacy, safety and tolerability of KN046 combined with platinum doublet chemotherapy in patients with advanced NSCLC. Here, we report results from a cohort of systemic therapy naive NSCLC pts with resistant oncogenic driver alterations.


        As of January 19, 2021, 12 pts (EGFR exon 20 insertion mutation, n=8; HER2 exon 20 insertion mutation, n=1; EGFR amplification, n=2; RET fusion, n=1) were enrolled. The median treatment duration of KN046 was 21 weeks.


        ORR was 50% (6/12; 95% CI: 21.1?78.9). Disease control rate (DCR) was 91.7% (11/12; 95% CI: 61.5–99.8). Median PFS was 8.7 months (95% CI: 4.1, NE). Median overall survival (OS) was not reached, and OS rate was 100% at 6 months.


        9 pts occurred at least 1 Grade ≥ 3 TEAEs, the most common were neutrophil count decreased (n=4, 33.3%), alanine aminotransferase increased (n=3, 25.0%), anaemia (n=2, 16.7%), white blood cell count decreased (n=2, 16.7%), aspartate aminotransferase increased (n=2, 16.7%). 5 (41.7%) pts experienced irAEs, all were of Grade 1 or 2.


        Professor Zhang Li from Sun Yat-sen University Cancer Center, the principal investigator, commented, “Lung cancer is the malignant tumor with the highest incidence and mortality in China,about 80% of lung cancers are NSCLC. Patients with EGFR and HER2 exon 20 insertion mutations have poor response and confer intrinsic resistance to currently available therapies. We are very pleased to see that Alphamab Oncology’s bispecific antibody KN046 demonstrates preliminary clinical benefit, providing a potential direction for treatment. We look forward to seeing more positive data from this study.”


        About KN046

        KN046 is PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a different mechanism CTLA-4 fused with PD-L1 single domain antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg(suppress tumor immunity) clearing function.


        There are about 20 clinical trials of KN046 in different stages covering more than 10 types of tumors including NSCLC, thymic cancer, pancreatic cancer, HCC, ESCC and TNBC in Australia and China. The results of these clinical trials have shown an advantage in survival for patients. Alphamab has received FDA clearance to enter phase Ⅱ trial of KN046 based on the clinical results in China and Australia. Moreover, KN046 has obtained the U.S. FDA's orphan drug designation for thymic epithelial tumor in September, 2020. Four registrational clinical trials are currently being conducted.


        About Alphamab Oncology

        Alphamab Oncology is a biopharmaceutical company focusing on innovative biologics medicine for oncology. On December 12, 2019, the Company was listed in the mainboard of Hong Kong Stock Exchange with stock code 9966.


        Alphamab has fully integrated proprietary biologics platforms in bi-specifics and protein engineering. Its highly differentiated in-house pipeline includes fifteen tumor monoclonal antibodies and bispecific antibodies and a Covid-19 multifunctional antibody. Four products have advanced into phase I-III clinical trials or pre-marketing stage in China, the United States, Japan and Australia. The BLA for Envafolimab (KN035) has been accepted and granted Priority Review by the National Medical Products Administration (NMPA).


        The Company also has state-of-the-art manufacturing capabilities designed and built to meet NMPA and EU/FDA’s cGMP standards and a complete quality system which has passed the on-site inspection of an European Union qualified person. Alphamab Oncology is committed to building a global leading, multi-dimensional drug development and commercialization platform, focusing on multifunctional biological innovative drugs, and to benefit patients in China and around the world.


        Alphamab Oncology Forward-Looking Statements

        This press release contains statements related to our future business and financial performance and future events or developments involving Alphamab Oncology that may constitute forward-looking statements. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. These statements may be identified by words such as "expect," "look forward to," "anticipate" "intend," "plan," "believe," "seek," "estimate," "will," "project" or words of similar meaning. We may also make forward-looking statements in other reports, in presentations, in material delivered to shareholders and in press releases. In addition, our representatives may from time to time make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Alphamab Oncology’s management and business operation, many of which are difficult to predict and generally beyond Alphamab Oncology’s control. These are subject to a number of risks and uncertainties, including but not limited to, uncertainties inherent in research and development, future clinical data and analysis, decisions by regulatory authorities regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Alphamab Oncology's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding and Alphamab Oncology’s disclosures. Should one or more of these risks or uncertainties materialize, or should underlying expectations not occur or assumptions prove incorrect, actual results, performance or achievements of Alphamab Oncology may (negatively or positively) vary materially from those described explicitly or implicitly in the relevant forward-looking statement. Other than as required by applicable law, Alphamab Oncology undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.