● kn046 showed good tolerability, safety and efficacy as 2nd line treatment of advanced non-small cell lung cancer (nsclc). the median progression-free survival was 3.68 months, of which squamous nsclc was 7.29 months. the median overall survival (os) was not reached, and the disease control rate (dcr) was as high as 70%. adverse events are reversible and monitorable.
● kn046 in patients with thymic epithelial tumors showed good safety and efficacy. kn046 has been granted orphan drug designation by fda for the treatment of thymic epithelial tumors. the objective response rate (orr) of the 4 cases of thymic epithelial tumors in the australia phase i clinical study was 75%, and the dcr was 100%.
● the phase iii pivotal clinical trial of kn046 as first-line treatment of squamous nsclc (enreach-lung-01) and the phase ii international registration clinical trial for the treatment of advanced thymic cancer (kn046-205) have been launched.
suzhou, february 1, 2021 - alphamab oncology (stock code: 9966.hk) announced that new data from the phase ii clinical study of kn046 (a bispecific anti-pd-l1/ctla-4) in patients with metastatic non-small cell lung cancer (nsclc) (clinical trial no.: kn046-201) and preliminary safety and efficacy results of kn046 in subjects with rare thoracic tumors were presented at the 2020 world conference on lung cancer (wclc 2020 virtual), poster presentation and mini oral presentation respectively.
the world conference on lung cancer (wclc) is the world's largest multidisciplinary oncology conference dedicated to lung cancer and other thoracic malignancies. the 2020 world conference on lung cancer (wclc 2020 virtual) is held from january 28 to 31, 2021.
title: a phase ii study of kn046 in patients with metastatic non-small cell lung cancer (nsclc)
presentation format: e-poster
abstract no.: #1665
reporter: department of oncology, shanghai pulmonary hospital, professor caicun zhou
kn046-201 is a phase ii, open label, multi-center clinical study aimed at evaluating the efficacy, safety and tolerability of kn046 in patients with metastatic non-small cell lung cancer as second line treatment. the results show that kn046 is well tolerated and effective as a second-line treatment of metastatic nsclc, and demonstrated progression-free survival (pfs) and overall survival (os) benefits.
a total of 64 nsclc patients who had previously received first-line systemic treatment were enrolled. the median duration of treatment was 3.8 months, and the median follow-up period was 13 months.
the median progression-free survival period was 3.68 months (95%ci 3.35, 7.29): squamous nsclc and non-squamous nsclc were 7.29 months (3.68, 9.23) and 3.58 months (2.46,5.52) respectively; median os was not reached; 6-month survival rate was 85.6%, 12-month survival rate was 69.7%. dcr is as high as 70%. the results compare favorably with historical data from other pd-(l)1 antibody therapeutics. in this study, patients with pd-l1≥1% accounted for 40%, and both pd-l1 positive and negative patients benefited.
in terms of safety, 24 of the 64 patients (37.5%) experienced related trae ≥ grade 3, including infusion related reaction (10.9%), anemia (4.7%), drug-induced liver injury (3.1%), hepatic function abnormal (3.1%), and lung infection (3.1%). immune-related adverse events (irae) is mainly neutrophil count decreased (3.1%) and white blood cell count decreased (3.1%). adverse events are reversible and monitorable.
title: preliminary safety and efficacy results of kn046 in subjects with rare thoracic tumors
presentation format: mini oral report
abstract no.: #1313
reporter: professor gary richardson
kn046-aus-001 is a phase i clinical study conducted in australia.
5 patients with thymic thoracic tumor were enrolled, including 4 cases of thymic epithelial tumor（2 cases of thymic carcinoma (stage iv), 2 cases of thymoma (stage iv) ）and 1 case of pleural mesothelioma (sarcomatoid variant, stage ⅲb). the median duration of treatment was 22.7 weeks (range: 16-48).
the confirmed disease response rate of kn046 in 4 cases of thymic epithelial tumors was 50%, the confirmed and unconfirmed disease response rate was 75% (2 confirmed pr and 1 unconfirmed pr), and the disease control rate was 100%.
3 of the 5 patients had 14 secondary immune-related adverse events, most of which were grade 1-2; only one patient had 2 times grade 3 treatment-related adverse events (autoimmune hepatitis and elevated alt).
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, tnbc, escc, hcc and pancreatic cancer 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. two 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 fourteen 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.
visit http://www.alphamabonc.com for more information.
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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.
