At the ESMO Congress 2026, Jihong Liu (Guangzhou, China) presented results from a randomized, double-blind phase III trial (NCT05446883), evaluating paromlimab and tuvonralimab (QL1706), a bifunctional antibody targeting PD-1 and CTLA-4, in combination with chemotherapy with or without bevacizumab in patients with persistent, recurrent, or metastatic cervical cancer.
The investigational combination significantly improved survival outcomes, achieving a median overall survival (OS) of 30.95 months compared with 21.78 months in the control group, alongside a significant progression-free survival (PFS) benefit.
Methods
The multicenter, randomized, double-blind, placebo-controlled phase III trial evaluated the efficacy and safety of QL1706 combined with first-line chemotherapy, with or without bevacizumab, in patients with persistent, recurrent, or metastatic cervical cancer.
A total of 492 patients were randomized 1:1 to receive QL1706 at 5 mg/kg or placebo alongside paclitaxel plus cisplatin or carboplatin, with optional bevacizumab at 15 mg/kg.
Treatment was administered every three weeks for six cycles, followed by maintenance QL1706 or placebo every three weeks for up to two years.
Randomization was stratified according to bevacizumab use, prior concurrent chemoradiotherapy, and PD-L1 combined positive score (CPS).
The primary endpoints were PFS assessed by blinded independent central review according to RECIST v1.1 and overall survival.
Key Takeaways
At the January 16, 2026, data cutoff, 243 patients had been randomized to QL1706 and 249 to placebo. Overall, 80.9% had PD-L1 CPS ≥1, and 48.4% had previously received concurrent chemoradiotherapy.
- Progression-free survival: Median PFS was 12.35 months with QL1706 versus 7.75 months with placebo (HR 0.64; 95% CI, 0.51–0.81; p=0.0001).
- Overall survival: Median OS reached 30.95 months with QL1706 compared with 21.78 months in the control group (HR 0.73; 95% CI, 0.57–0.93; p=0.0101).
- Survival improvement: QL1706 was associated with a 9.17-month difference in median OS and a 27% relative reduction in the hazard of death.
- Subgroup outcomes: PFS and OS benefits favored QL1706 regardless of age, distant metastases, previous chemoradiotherapy, PD-L1 expression, or bevacizumab administration.
- Bevacizumab use: Bevacizumab was administered to 77.4% of patients in the QL1706 group and 75.1% in the placebo group.
- Treatment-related adverse events: TRAEs occurred in 98.8% of patients receiving QL1706 and 99.2% receiving placebo.
- Grade ≥3 treatment-related adverse events: Reported in 80.6% of patients receiving QL1706 versus 75.9% in the control group.
The safety profile was considered manageable, with no new safety signals identified.
Conclusion
The phase III trial demonstrated that adding paromlimab and tuvonralimab (QL1706) to first-line chemotherapy, with or without bevacizumab, significantly improved progression-free and overall survival in patients with persistent, recurrent, or metastatic cervical cancer.
The 9.17-month improvement in median overall survival, together with a 36% relative reduction in the hazard of disease progression or death, supports the clinical activity of dual PD-1/CTLA-4 blockade in this setting.
Survival benefits were observed across the reported subgroups, including patients with different PD-L1 expression levels and those receiving treatment with or without bevacizumab. However, subgroup findings should be interpreted cautiously.
Although grade ≥3 treatment-related adverse events were frequent in both arms, no new safety signals emerged.
These findings provide further evidence supporting dual immune checkpoint blockade as a treatment strategy for advanced cervical cancer, while additional evaluation will help define its role alongside established first-line immunotherapy regimens.
Source: ESMO Congress 2026, QL1706 Phase III Abstract; NCT05446883.
