2024 World Conference on Lung Cancer (WCLC) - ePosters-EP.14D.01 Cadonilimab Plus Bevacizumab and Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma: A Single-Arm Phase II Study

EP.14D.01 Cadonilimab Plus Bevacizumab and Chemotherapy as First Line Therapy in Unresectable Pleural Mesothelioma: A Single-Arm Phase II Study

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Pleural mesothelioma, often diagnosed at an advanced stage, primarily relies on systemic therapy due to its unresectable nature. The standard treatment involves platinum–pemetrexed chemotherapy, sometimes combined with bevacizumab, yielding median survival times of 12-18 months. Immunotherapies such as nivolumab and ipilimumab have shown enhanced survival benefits, especially in non-epithelioid cases, but there remains a critical need for improved treatments.<br /><br />Cadonilimab, or AK104, appears promising as a first-in-class bispecific antibody targeting PD-1 and CTLA-4, showing efficacy and manageable safety in early studies. In a phase 1 study (COMPASSION-01) with mesothelioma patients unresponsive to standard therapies, cadonilimab achieved an overall response rate (ORR) of 20% and a disease control rate (DCR) of 75%. Median progression-free survival (PFS) was noted at 5.5 months, with median overall survival (OS) at 15.6 months.<br /><br />Currently, a phase 2 study is investigating cadonilimab combined with bevacizumab and chemotherapy as a first-line treatment for unresectable pleural mesothelioma. The study uses a single-arm design, enrolling patients with histologically confirmed pleural mesothelioma, who have not undergone prior systemic therapy. This approach evaluates this combination's efficacy through endpoints like ORR, PFS, DCR, and OS, alongside safety assessments.<br /><br />This trial applies Simon’s two-stage design to gauge the therapy’s impact, with an initial cohort of 19 patients, potentially expanding to 38 to accommodate dropouts. Regular tumor assessments and adverse event monitoring are integral parts of the study. Enrollment began in November 2023, with various sites across China participating. The ultimate goal is to establish an enhanced therapeutic option for this challenging cancer type, possibly improving patient outcomes significantly.

Asset Subtitle

wenfeng fang

Meta Tag

Speaker wenfeng fang

Topic Mesothelioma, Thymoma, and Other Thoracic Tumors

Keywords

pleural mesothelioma

systemic therapy

platinum–pemetrexed chemotherapy

immunotherapy

cadonilimab

bispecific antibody

COMPASSION-01

phase 2 study

Simon’s two-stage design

unresectable cancer