The promising results of a phase II clinical study for Akeso's Cadonilimab (PD-1/CTLA-4) combined standard treatment for first-line treatment of R/M cervical cancer has been published in Clinical Cancer Research

HONG KONG, Feb. 28, 2024 /PRNewswire/ -- Akeso (9926.HK) announced that the results of a phase II clinical trial for PD-1/CTLA-4 bispecific antibody（cadonilimab）combined with standard treatment (chemotherapy +/- bevacizumab) as first-line treatment for recurrent/metastatic cervical cancer had been published in the official journal of the American Association for Cancer Research (AACR), Clinical Cancer Research, with an impact factor of 11.5.

The article comprehensively elaborates on the excellent therapeutic effects of cadonilimab as first-line treatment for the whole population of cervical cancer, demonstrating the good safety profile of this treatment regimen. The publication of this article further enriches the evidence-based medicine evidence for the clinical application of cadonilimab.

The study data published in Clinical Cancer Research this time continues to demonstrate the pronounced advantages presented in the data published at the 2022 American Society of Clinical Oncology (ASCO) annual meeting, and with further extension of follow-up time, the efficacy advantage of cadonilimab combined with standard treatment for first-line treatment of recurrent/metastatic cervical cancer becomes more evident. Once again, it shows the clinical potential of cadonilimab for the entire population of recurrent/metastatic cervical cancer regardless of PD-L1 expression status, with the main research data superior to the data disclosed in current standard of care with immunotherapy-based combination therapy (non-head-to-head).

• Compared to the data disclosed at ASCO in 2022, the overall objective response rate (ORR) remains at a high level, with the disease control rate (DCR) increasing to 100%, and the complete response (CR) rate further increasing.

63.6% of patients experienced tumor reduction of more than 50%. The ORR of the 10mg/kg Q3W dose group (cadonilimab 10mg/kg Q3W + chemotherapy +/- bevacizumab) reached 79.3%, and when combined with bevacizumab, the ORR was as high as 92.3%. The population with PD-L1 CPS <1 accounted for 41.4%, and the ORR of this population was 75.0%, indicating that cadonilimab combined with standard treatment could provide clinical benefit for PD-L1-negative patients.

• Cadonilimab combined standard treatment brings excellent long-term survival benefits.

The median follow-up time for the cadonilimab 15mg/kg Q3W + chemotherapy group was 20.24 months, the median progression-free survival (mPFS) was 11.10 months, the median overall survival (mOS) was not reached, and the 12-month OS rate was 93.3%. The median follow-up time for the cadonilimab 10mg/kg Q3W + chemotherapy group was 18.3 months, the mPFS was 7.06 months, the mOS was not reached, and the 12-month OS rate was 87.5%. The median follow-up time for the Cadonilimab 10mg/kg Q3W + chemotherapy + bevacizumab group was 15.01 months, and neither mPFS nor mOS was reached.

• The safety of cadonilimab combined with standard treatment is manageable, and no new safety signals have been observed.

Reports indicate that in 2020, there were approximately 604,000 new cases of cervical cancer globally, with over 110,000 cases in China. It is estimated that by 2040, the number of deaths from cervical cancer in China will reach 75,000 cases, representing a 26.3% increase compared to 2020. The 5-year survival rate for advanced cervical cancer is only about 17.0%. In first-line treatment for advanced cervical cancer, chemotherapy+/-bevacizumab is the standard treatment regimen domestically, with limited efficacy and no approved immune combination therapy.

Cadonilimab was approved by the China National Medical Products Administration (NMPA) in June 2022 for second-line treatment of recurrent/metastatic cervical cancer. Since its launch, Cadonilimab's outstanding clinical value and good safety profile have been strongly validated in numerous clinical studies and real-world clinical applications. It has demonstrated prominent benefits for the entire population of patients with advanced cervical cancer, improving survival rates and quality of life, thus addressing the current important clinical need.

In November 2023, an interim analysis of a randomized, double-blind, placebo-controlled phase III study of cadonilimab as first-line treatment for cervical cancer showed that the primary endpoint of progression-free survival (PFS) had been met. Soon, the population of patients with advanced cervical cancer in China will have access to immune combination therapy. Additionally, a randomized, double-blind, placebo-controlled Phase III study of cadonilimab combined with chemotherapy as first-line treatment for gastric cancer also met the primary endpoint of overall survival (OS) in the interim analysis, and a new drug application had been accepted by CDE. With positive results from registration trials of cadonilimab in first-line treatments of multiple tumor types, the population benefiting from cadonilimab will rapidly expand, better realizing the clinical value of this cadonilimab for tumor treatment and benefiting more patients.

About Cadonilimab

Cadonilimab is a first-in-class bispecific antibody targeting both PD-1 and CTLA-4 which is  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 practice 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 OS. 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, NDAs for 4 drugs and 6 indications accepted, and 13 ongoing Phase III studies. Utilizing its proprietary Tetrabody technology, Akeso has successfully developed the first-in-class PD-1/CTLA-4 bispecific antibody drug to 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 and granted Priority Review. Akeso is listed on the Main Board of the Stock Exchange of Hong Kong Limited.

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SOURCE Akeso, Inc.