Akeso received an NDA for cadonilimab from the Chinese authorities for the combination therapy in gastic cancer in January 2024. Image credit: Getty Images / SEBASTIAN KAULITZKI/SCIENCE PHOTO LIBRARY

Akeso Biopharma has announced positive interim data from its Phase III trial of cadonilimab and xelox as a first-line therapy for unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma (G/GEJAC).

The COMPASSION-15 study (NCT05008783) is a randomised, quadruple blind, multi-centre study which is pitting cadonilimab, a PD-1/CTLA-4 bispecific antibody, and xelox, a combination of two chemotherapies capecitabine and oxaliplatin, versus placebo and xelox in stomach cancer patients. The study is taking place at sites across China and 610 patients have been enrolled on the trial.

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The interim analysis showed that cadonilimab plus chemotherapy increased overall survival (OS) at 15 months compared to 10.8 months in the chemotherapy group. Median progression-free survival (PFS) also improved in the combination therapy group at 7.0 months compared to 5.3 months in the chemotherapy cohort.

The objective response rate (ORR) of the combination therapy was 65.2% compared to 48.9% in the chemotherapy cohort. The treatment group also saw a significant improvement in tumour treatment response, increasing ORR by 33.3%.

The median duration of response (DOR) of the combination therapy group was double that of the chemotherapy group at 8.8 months compared to 4.4 months.

Subsequent systemic treatment was also lower in the treatment group at 36.4% compared to 50.5% in the chemotherapy arm.

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The data was announced in an oral presentation at the 2024 American Association for Cancer Research (AACR) on 8 April. The company’s stock increased following the announcement from HK$46.65 (US$5.96) on 8 April to HK$48.80 (US$6.23) on 9 April.

This most recent data comes three months after a new drug application (NDA) was accepted by China National Medical Products Administration (NMPA) for cadonilimab and xelox in this patient population in January 2024. This is the second indication in which cadonilimab has received approval in China, following its use as a monotherapy treatment for recurrent or metastatic cervical cancer.

Gastric cancer landscape

Gastric cancer is characterised by a high incidence and mortality rate, ranking fifth and fourth respectively among all common cancers worldwide. The incidence of gastric adenocarcinoma, which accounts for more than 90% of gastric malignancies, has been on the rise in recent years, particularly in GEJAC.

Early diagnosis of gastric cancer is crucial for a better prognosis, but the early symptoms can be vague, leading to late-stage diagnosis. There is also a need for better treatment options, especially in stage II-III G/GEJAC, as curative treatments are currently limited to the surgically resectable group.