Supplemental New Drug Application for Akeso’s Cadonilimab (PD-1/CTLA-4) Accepted by NMPA for First-line Treatment of Gastric Cancer

HONG KONG, Jan. 5, 2024 /PRNewswire/ — Akeso (9926.HK) announced the China National Medical Products Administration (NMPA) has accepted the supplemental new drug application (sNDA) of cadonilimab (开坦尼®, PD-1/CTLA-4 bispecific antibody, AK104) in combination with capecitabine plus oxaliplatin (XELOX) for first-line treatment of unresectable locally advanced, recurrent or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.

This will be the second indication for which cadonilimab has received approval in China, following its use as a monotherapy treatment for recurrent or metastatic cervical cancer.

The sNDA acceptance was based on the results from the AK104-302 trial, representing the first Phase III clinical study of a PD-1/CTLA-4 bispecific antibody combined with chemotherapy for first-line treatment of gastric cancer. In November 2023, AK104-302 trial achieved its primary endpoint by demonstrating a statistically significant overall survival (OS) improvement.

Cadonilimab combined with chemotherapy significantly reduced the risk of death in all-comer patients, including those with PD-L1 CPS≥5 and PD-L1 CPS < 5. The hazard ratios (HRs) for OS among patients with different PD-L1 status were superior to the disclosed PD-1 plus chemotherapy combination treatments. The combination of cadonilimab and chemotherapy also demonstrated superior OS in patients with PD-L1 CPS < 5 as well as PD-L1 negative.

“In the real world, approximately 60% of patients exhibit low PD-L1 expression, which further underscores the need for more effective treatment options,” said Professor Ji Jiafu from the Peking University Cancer Hospital. “There is a significant need to enhance overall effectiveness, particularly among patients with low PD-L1 expression. The combination of cadonilimab therapy for first-line treatment of advanced gastric cancer has shown a high tumor objective remission rate, significantly improve the overall survival of the entire population with advanced gastric cancer while reducing the risk of death. We are eagerly awaiting the earliest approval of this indication and the positive impact it will have on patients’ lives.”

“The combination therapy of cadonilimab demonstrates differentiated efficacy advantages compared to commonly used immunotherapy approaches in clinical practice,” said Professor Lin Shen from the Peking University Cancer Hospital. “It brings significant benefits to all-comer patients regardless of PD-L1 expression, and even demonstrated strong anti-tumor effects in patients with low PD-L1 expression or negative status. This addresses the limitations of current single-target immunotherapy in clinical settings, effectively showcasing the synergistic mechanism of ‘PD-1+CTLA-4’ dual immune therapy. It is expected to overcome the shortcomings of current immune treatment strategies for advanced gastric cancer and represents a potentially superior immunotherapeutic approach for this condition.”

“We would like to express our sincere gratitude to all the investigators, participants, and patients who actively participated in the clinical trial,” said Dr. Yu Xia, Founder, Chairwoman, President, and CEO of Akeso. “The groundbreaking bispecific IO therapy from cadonilimab will soon bring significant benefits to approximately 500,000 gastric cancer patients in China, underscoring the immense clinical and market value of cadonilimab as the first PD-1/CTLA-4 bispecific antibody. Since its approval for cervical cancer treatment in 2022, cadonilimab has garnered recognition from both clinicians and patients due to its remarkable efficacy and safety. We eagerly anticipate the approval of its new indication for gastric cancer, as it will revolutionize the clinical treatment approach for advanced gastric cancer and introduce a new era of immunotherapy options for patients.”

About AK104-302 trial

AK104-302 is a Phase III randomized, double-blind, multi-center clinical trial evaluating the use of cadonilimab ( the world’s first approved PD-1/CTLA-4 bispecific antibody) in combination with XELOX as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma. This study aims to assess the efficacy of cadonilimab plus XELOX compared to placebo plus XELOX in the intent-to-treat (ITT) population. The AK104-302 trial represents the first Phase III clinical study of a PD-1/CTLA-4 bispecific antibody combined with chemotherapy for first-line treatment of gastric cancer. Approximately 60% of patients in the ITT population had a PD-L1 CPS＜5, a proportion comparable to real-world scenarios.

About Cadonilimab

Cadonilimab is a first-in-class bispecific antibody that targets both PD-1 and CTLA-4 developed by Akeso. In Jun 2022, the China National Medical Products Administration (NMPA) approved cadonilimab for recurrent or metastatic cervical cancer. Cadonilimab has been included and recommended in multiple clinical guidelines such as CSCO. Cadonilimab has been engaged in more than 60 ongoing clinical trials including investigator-initiated studies.

Currently, a Phase III study of cadonilimab for first-line treatment of gastric cancer has met its endpoint of PFS. A Phase III study of cadonilimab has also met one of its primary endpoints of PFS for first-line treatment of recurrent/metastatic cervical cancer (R/M CC).

About Akeso, Inc.

Akeso (HKEX: 09926) is a commercial-stage biopharmaceutical company committed to discovering, developing, manufacturing, and commercializing innovative medicines that address significant medical needs globally. Since our inception, we have established a distinctive and integrated R&D innovation system with the comprehensive end-to-end drug development platform (ACE Platform) and bi-specific antibody drug development technology (Tetrabody) as the fundamental components, a GMP-compliant manufacturing system and a commercialization system with an advanced operation mode.

Akeso is actively developing a diverse pipeline of over 30 innovative assets in areas such as cancer, autoimmune disease, inflammation, metabolic disease, and other therapeutic fields. Among these, 19 assets have entered the clinical stage, with 3 innovative drugs already approved, 13 Phase III studies ongoing. Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA-4 bispecific antibody drug for the market. Additionally, the company has five other innovative bispecific antibody drugs in the clinical stage, including ivonescimab (PD-1/VEGF), PD-1/LAG-3, TIGIT/TGF-Beta, PD-1/CD73, and claudin18.2/CD47 bispecific antibodies.

In June 2022, cadonilimab was approved by the NMPA and became the first commercialized bispecific IO drug globally. Another Akeso internally discovered and developed oncology product, penpulimab (a PD-1 antibody), was granted marketing approval in China in August 2021. In December 2022, Akeso entered into a collaboration and license agreement for up to US$5 billion with Summit Therapeutics to accelerate global development and commercialization of ivonescimab. In August, the NDA submission of ivonescimab was accepted by China’s NMPA with priority review. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited.

For more information, please visit https://www.akesobio.com/en/

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