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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 | ||
By: PR Newswire Association LLC. - 08 Apr 2024 | Back to overview list |
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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?
Cadonilimab combination therapy as first-line treatment for advanced gastric cancer is highly efficient in anti-tumor response, doubling the duration of response.
Cadonilimab combination therapy significantly enhances long-term survival, with the advantage becoming more prominent with longer follow-up periods.
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.
SOURCE Akeso, Inc. |
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