Subgroup Data Sustain Cadonilimab Survival Benefit in Cervical Cancer
The survival benefit with cadonilimab in cervical cancer in the overall phase 3 COMPASSION-16 study population was sustained across prespecified subgroups.
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The overall survival (OS) and progression-free survival (PFS) benefits observed with the addition of cadonilimab to first-line standard therapy in patients with persistent, recurrent, or metastatic cervical cancer in the phase 3 COMPASSION-16 study were sustained across prespecified subgroups, according to data from the phase 3 COMPASSION-16 study presented at the 2025 ASCO Annual Meeting.1
Previously reported interim analyses from the COMPASSION-16 study demonstrated statistically significant improvements in both PFS and OS, with a median PFS of 13.3 months with cadonilimab versus 8.2 months with placebo (HR, 0.62; P <.0001) and a median OS not yet reached versus 22.8 months, respectively (HR, 0.64; P =.0011).
The subgroup analyses presented at ASCO showed that these benefits with cadonilimab held up across subgroups defined by prior concurrent chemoradiation therapy (CCRT; yes: PFS HR, 0.55; OS HR, 0.54; no: PFS, HR, 0.67; OS HR, 0.76), bevacizumab (Avastin) not being used (PFS HR, 0.44; OS HR, 0.50), age (<65: PFS HR, 0.68; OS HR, 0.69; ≥65: PFS HR, 0.39; OS HR, 0.49), and platinum type (cisplatin: PFS HR, 0.49; OS HR, 043.; carboplatin: PFS HR, 0.72.; OS HR, 0.82).
“Notably, cadonilimab showed the greatest benefit in patients with prior CCRT, no bevacizumab use, and age ≥65,” said Xiaohua Wu, MD, Fudan University Shanghai Cancer Center, Shanghai, China.
No new safety signals were reported from the subgroup analysis.
“These findings further support cadonilimab as a first-line therapeutic option for recurrent or metastatic cervical cancer,” said Wu.
COMPASSION-16 Design and Patient Characteristics
Cadonilimab is a first-in-class bispecific antibody engineered to concurrently target PD-1 and CTLA-4, enabling dual immune checkpoint inhibition within a single molecule.
Key eligibility criteria for the randomized, multicenter, double-blind phase 3 COMPASSION-16 trial were persistent, recurrent, or metastatic cervical cancer, histologically confirmed as squamous cell carcinoma, adenocarcinoma, or adenosquamous carcinoma; no prior systemic therapy; and an ECOG performance status of 0 or 1. Stratification factors were prior CCRT and receipt of bevacizumab.
Patient characteristics were well balanced between the study arms. Across all patients, the median patient age was 55 years (range 23-75) and about 65% of patients had an ECOG performance status of 1. Almost half (48%) of patients had prior CCRT, about 43% had prior cisplatin, and 60% received bevacizumab. Over 70% of patients had metastatic disease, with lymph nodes, lung, bone, and liver being the primary sites of metastasis. Regarding PD-L1 expression, about 70% of patients had a combined positive score (CPS) ≥1 and 40% had a CPS ≥10.
In the experimental arm (n = 222), patients received cadonilimab at 10 mg/kg in combination with paclitaxel 175 mg/m² and either cisplatin 50 mg/m² or carboplatin (AUC 4–5), with or without bevacizumab 15 mg/kg, administered every 3 weeks for 6 cycles. This was followed by maintenance therapy with cadonilimab at 10 mg/kg every 3 weeks, with or without bevacizumab at 15 mg/kg on the same schedule.
In the control arm (n = 223), patients were treated with Patients in the control arm received placebo in combination with paclitaxel 175 mg/m² and either cisplatin 50 mg/m² or carboplatin (AUC 4–5), with or without bevacizumab 15 mg/kg, administered every 3 weeks for 6 cycles. Patients then received maintenance with placebo with or without bevacizumab at 15 mg/kg every 3 weeks.
Treatment was continued until disease progression, unacceptable toxicity, or completion of 2 years of cadonilimab or placebo. The primary end points were PFS and OS. Secondary end points included response and safety.
In 2020, cadonilimab received fast track designation from the FDA for the treatment of patients with recurrent or metastatic squamous cervical cancer who have disease progression on or after platinum-based chemotherapy.2
Cadonilimab was approved in China June 2020 for use in combination with platinum-based chemotherapy with or without bevacizumab for the first-line treatment of patients with persistent, recurrent, or metastatic cervical cancer.3
