Akeso (9926) IGCS 2024 Presentation summary

Study background and objectives

• Cadonilimab is a bi-specific antibody targeting PD-1 and CTLA-4, approved in China for advanced cervical cancer in later lines regardless of PD-L1 status.

• Pembrolizumab plus chemotherapy ± bevacizumab is the current first-line standard for PD-L1 positive cases.

• Prior phase II data showed high ORR and OS with cadonilimab plus chemotherapy ± bevacizumab in first-line cervical cancer.

• COMPASSION-16 is a phase III, randomized, double-blind, placebo-controlled trial evaluating cadonilimab plus chemotherapy ± bevacizumab as first-line treatment.

• The study aims to assess efficacy and safety in persistent, recurrent, or metastatic cervical cancer.

Study design and patient characteristics

• 445 patients were randomized 1:1 to cadonilimab (n=222) or placebo (n=223), both with chemotherapy ± bevacizumab.

• Eligible patients had persistent, recurrent, or metastatic cervical cancer, ECOG PS 0-1, and no prior systemic therapy.

• Median age was 55.9 years; most had squamous cell carcinoma and metastatic disease.

• Baseline characteristics were balanced between groups, including PD-L1 status and prior CCRT.

• Median follow-up at OS interim analysis was 25.63 months.

Efficacy results

• Median PFS was 12.7 months for cadonilimab vs 8.1 months for placebo (HR 0.62, p<0.0001).

• Median OS was not reached for cadonilimab vs 22.8 months for placebo (HR 0.64, p=0.0011).

• 12-month OS rate: 83.1% (cadonilimab) vs 73.7% (placebo); 24-month OS: 62.6% vs 48.4%.

• ORR was 82.9% for cadonilimab vs 68.6% for placebo; median DoR was 13.2 vs 8.2 months.

• Benefit was consistent across all subgroups, including those without bevacizumab and with PD-L1 CPS<1.