Akeso, Inc. announced that the positive interim analysis results from Phase III clinical study of Cadonilimab combined with XELOX as first-line treatment for unresectable locally advanced or metastatic gastric or gastroesophageal junction adenocarcinoma were released presented in the form of oral presentation at the 2024 American Association for Cancer Research.
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 <5 (PD-L1 low expression) and PD-L1 CPS <1 (PD-L1 negative) in the intention-to-treat population (ITT) were 49.8% and 23%, respectively, which is much higher than that in previous Phase III clinical studies of immune checkpoint inhibitors combined regimens for first-line gastric cancer globally. Previous studies have shown that patients with PD-L1 low expression/negative generally have poor efficacy with immunotherapy.
As of the interim analysis, with a median follow-up of 18.7 months, the proportions of subsequent systemic treatment in the Cadonilimab combination therapy group and chemotherapy group were 36.4% vs 50.5%, respectively, and the proportions of subsequent treatment using PD-1/PD-L1 inhibitors were 11.1% vs 21.6%, respectively.
The results showed that regardless of PD-L1 expression, Cadonilimab combination therapy significantly prolonged patients’ overall survival benefits and reduced the risk of death compared to chemotherapy, with outstanding benefits in objective response and long-term survival. Even for the patients with low PD-L1 expression, it also showed excellent efficacy, which is expected to compensate for the limited efficacy of PD-1 monotherapy for first-line treatment of low PD-L1 expression gastric cancer, providing a more comprehensive and efficient immunotherapy regimen for advanced gastric cancer patients.
Cadonilimab plus chemo therapy significantly prolonged survival benefits as first-line treatment for advanced gastric cancer, comprehensively reducing the risk of progression/death.
l In the ITT population，the median overall survival (mOS) was longer in the combination therapy group versus the chemotherapy group (HR=0.62 ，mOS 15.0mo vs 10.8 mo; P<0.001)，with a 39% prolongation of mOS and a 38% reduction in the risk of death；
- 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<0.001);
- When PD-L1 CPS<5, the mOS was 14.8 months vs 11.1 months, with a 33.3% prolongation of mOS and a 30% reduction in the risk of death (HR=0.7, P=0.011);
- 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<0.001).
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<5, the 12-month OS rates were 56.9% vs 45.1%;
- In the ITT population, the 18-month OS rates of Cadonilimab combination therapy vs chemotherapy were 45.8% vs 25.5%; when CPS≥5, the 18-month OS rates were 51.2% vs 23.5%; when CPS<5, the 18-month OS rates were 44.1% vs 27.5%;
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.
View original content:SOURCE Akeso, Inc.
Company Codes: HongKong:9926
