Oral report | The positive interim analysis results from the Phase III clinical study of Akeso's Cadonilimab (PD-1/CTLA-4 BsAb) plus chemotherapy as first-line treatment for advanced gastric cancer presented at 2024 AACR

08 Apr 2024
www.prnewswire.com
Clinical ResultPhase 3AACRImmunotherapyNDA
SAN DIEGO, April 8, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) today announced that
the positive interim analysis results from Phase III clinical study
of Cadonilimab (PD-1/CTLA-4 BsAb) combined with XELOX (capecitabine plus oxaliplatin) as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma (AK104-302/COMPASSION-15) were released presented in the form of oral presentation at the 2024 American Association for Cancer Research (AACR).
The COMPASSION-15 is the world's first Phase III clinical study of PD-1/CTLA-4 bispecific antibody combined with chemotherapy as first-line treatment for gastric cancer. In COMPASSION-15 , the proportions of patients with PD-L1 CPS
The OS benefits stratified by different CPS values were consistent with the overall population, with equally excellent efficacy in low PD-L1 expression:
When PD-L1 CPS≥5, the mOS of Cadonilimab combination therapy group compared to the chemotherapy group was not reached vs 10.6 months, with a 44% reduction in the risk of death (HR=0.56, P
The median progression-free survival (mPFS) in the ITT population was 7.0 months and 5.3 months, respectively, with a 32% prolongation of mPFS and a 47% reduction in the risk of disease progression (HR=0.53, P
Cadonilimab combination therapy as first-line treatment for advanced gastric cancer is highly efficient in anti-tumor response, doubling the duration of response.
The objective response rates (ORR) of Cadonilimab combination therapy and chemotherapy were 65.2% and 48.9%, respectively, with a significant improvement in tumor treatment response with Cadonilimab combination therapy, increasing ORR by 33.3%;
The median duration of response (mDOR) with Cadonilimab combination therapy was twice that of chemotherapy (8.8 months vs 4.4 months).
Cadonilimab combination therapy significantly enhances long-term survival, with the advantage becoming more prominent with longer follow-up periods.
In the ITT population, the 12-month OS rates of Cadonilimab combination therapy vs chemotherapy were 57.3% vs 43.7%; when CPS≥5, the 12-month OS rates were 58% vs 44.1%; when CPS
In January 2024, based on the results of the AK104-302/COMPASSION-15 study, Akeso's new drug application (NDA) for Cadonilimab combined with XELOX as first-line treatment for unresectable locally advanced or metastatic G/GEJ adenocarcinoma has been successfully accepted.
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