Akeso’s Latest Updates of a Phase Ib/II Trial of AK104 (PD-1/CTLA-4 Bi-Specific Antibody) in Combination with Anlotinib in Patients with PD-L1 Positive and Anti-PD-1/L1 Resistant Advanced NSCLC at ESMO 2021

On 18 Sept 2021, Akeso, Inc. (9926.HK, “the Company”) announces that at the European Society for Medical Oncology Congress of 2021 (ESMO 2021) on 16-21 September, latest updates of a phase Ib/II trial of Cadonilimab (AK104, PD-1/CTLA-4 bi-specific antibody) in combination with Anlotinib in patients with PD-L1 positive and anti-PD-1/L1 resistant advanced non-small cell lung cancer (NSCLC) were published in the form of poster. The e-Poster can be accessed on the website of Akeso at http://www.akesobio.com.


Research title: A phase Ib/II trial of AK104 (PD-1/CTLA-4 bispecific antibody) in combination with anlotinib in advanced NSCLC


Abstract number: 1300P


First author: Prof. Wu Lin, Hunan Cancer Hospital


Cadonilimab is a bispecific antibody, capable of simultaneously binding PD-1 and CTLA-4 with high affinity. Anlotinib targets vascular endothelial growth factor receptor, thereby exerting inhibitory effects on tumor growth and angiogenesis. Published data suggests that the combination therapy of checkpoint inhibitors with anti-angiogenic agents produces complementary and synergistic antitumor effects. The purpose of this study (NCT04646330) is to explore a new way without chemotherapy by consolidating the efficacy of checkpoint inhibitors in combination with anti-angiogenic agents, and therapy for anti-PD-1/L1 resistant patients.


This is a phase Ib/II, open-label, multicenter clinical study, including 2 cohorts of treatment-naïve PD-L1 positive patients with advanced NSCLC and anti-PD-1/L1 resistant patients. Patients all received AK104 15 mg/kg every 3 weeks and 12mg anlotinib 2 weeks on/1 week off.


As of August 2021, 38 patients were enrolled, among which 21 were treatment-naïve PD-L1 positive patients and 17 were anti-PD-1/L1 resistant patients.


The results show that the combination therapy has a favorable safety profile: no drug-related death occurred in treatment-naïve patients with PD-L1 positive and anti-PD-1/L1 resistant patients, Grade 3 Cadonilimab-related treatment emergent adverse event (TEAE) was 14.3% and 5.9%.


Meanwhile, study results also show that Cadonilimab in combination with Anlotinib has significant efficacy for treatment of NSCLC: in 17 assessable treatment-naïve patients with PD-L1 positive, achieved the objective response rate (ORR) of 70.6% and disease control rate (DCR) of 94.1%; in 6 assessable anti-PD-1/L1 resistant patients, ORR was 16.7% and DCR achieved 100%.


The study suggests that Cadonilimab plus Anlotinib have showed favorable anti-tumor activity and an acceptable safety profile in treatment-naïve patients with PD-L1 positive and anti-PD-1/L1 resistant patients. This proposes a promising new direction for treatment of advanced NSCLC, especially for patients with anti-PD-1/L1 resistant patients, which worth further development.


About Cadonilimab (PD-1/CTLA-4 Bi-specific Antibody)

Cadonilimab (AK104) is a novel, potential next-generation, first-in-class bi-specific PD-1/CTLA-4 immuno-oncology backbone drug independently developed by the Company, and its major indications include liver cancer, cervical cancer, lung cancer, gastric cancer, esophageal squamous cell cancer and nasopharyngeal carcinoma. The preliminary research data of cervical cancer, gastric cancer and other tumors shows that, as compared with the combination therapy of PD-1 and CTLA-4, Cadonilimab has much lower toxicity and demonstrated promising safety profile and efficacy.


Information about Akeso, Inc.

Akeso, Inc. is a biopharmaceutical company dedicated to the research, development, manufacturing and commercialization of new innovative antibody drugs that are affordable   to patients worldwide. Since the Company’s establishment, the Company has established an end-to-end comprehensive drug development platform (ACE Platform) and system, encompassing fully integrated drug discovery and development functions, including target validation, antibody drug discovery and development, CMC production process development, and GMP compliant scale production. The Company has also successfully developed a bi-specific antibody drug development technology (Tetrabody technology). The Company currently has a pipeline of over 20 innovative drugs for the treatment of major diseases like tumors, autoimmune diseases, inflammation and metabolism diseases, 13 of which have entered clinical stage, including two first-in-class bi-specific antibody drugs (PD-1/CTLA-4 and PD-1/VEGF). In Aug 2021, the Company’s first in-house innovatively researched and developed differentiated PD-1 monoclonal antibody Penpulimab monoclonal antibody injection (安尼可®) was approved to the market. The Company’s vision is to become a global leading biopharmaceutical company through research and development (‘‘R&D’’) of high efficacy and breakthrough new drugs that are first-in-class and best-in-class therapies.