At the ESMO Congress 2026, Jieping Chen (Guangzhou, China) presented findings from a phase II study (NCT06654440) evaluating SHR-A2102, a novel nectin-4-targeted antibody–drug conjugate (ADC), in patients with recurrent or metastatic cervical cancer.
The investigational therapy demonstrated promising antitumor activity, achieving a confirmed objective response rate (ORR) of 47.2% at the 6 mg/kg dose, with a median progression-free survival (PFS) of 7.0 months in patients previously treated with platinum-based chemotherapy.
Methods
The multicenter, open-label phase II study evaluated the efficacy and safety of SHR-A2102, an ADC comprising a nectin-4-targeting monoclonal antibody, a cleavable linker, and a topoisomerase I inhibitor payload.
Eligible patients were aged 18–75 years, had recurrent or metastatic cervical cancer that progressed following platinum-based chemotherapy, and had received no more than two prior lines of systemic therapy.
A total of 50 patients were enrolled, receiving intravenous SHR-A2102 at either 6 mg/kg (n=36) or 8 mg/kg (n=14) every three weeks. The primary endpoint was investigator-assessed ORR according to RECIST v1.1.
The median patient age was 55 years. Among participants, 78% had previously received PD-1/PD-L1 inhibitors, 66% bevacizumab, and 38% two prior lines of systemic therapy.
Key Takeaways
At the January 30, 2026, data cutoff, the median follow-up was 8.8 months.
- Confirmed objective response rate: 47.2% at 6 mg/kg, 21.4% at 8 mg/kg, and 40.0% across the overall population.
- Disease control rate: 88.9% at 6 mg/kg, 85.7% at 8 mg/kg, and 88.0% overall.
- Median progression-free survival: 7.0 months at 6 mg/kg, 5.5 months at 8 mg/kg, and 5.9 months overall.
- Median duration of response: 7.1 months at 6 mg/kg, 4.2 months at 8 mg/kg, and 7.1 months overall.
- Median overall survival: Not reached in either dose group or the overall population.
- Safety: Grade ≥3 treatment-related adverse events occurred in 58% (29/50) of patients. The most common were decreased neutrophil count (26%), anemia (22%), and decreased white blood cell count (20%).
- Treatment discontinuation: No treatment-related adverse events led to treatment discontinuation.
The 6 mg/kg cohort showed a higher confirmed response rate than the 8 mg/kg cohort, although the small sample sizes and nonrandomized design limit direct dose comparisons.
Conclusion
SHR-A2102 demonstrated encouraging antitumor activity in patients with recurrent or metastatic cervical cancer who had progressed after platinum-based chemotherapy, including a population with substantial prior exposure to immune checkpoint inhibitors.
The 47.2% confirmed response rate and 7.0-month median PFS at 6 mg/kg support further investigation of nectin-4-targeted ADC therapy in this setting. However, grade ≥3 hematologic toxicities were relatively frequent, highlighting the importance of continued safety assessment.
These findings support further clinical development, with a pivotal phase III trial (NCT07418749) ongoing to evaluate the clinical benefit of SHR-A2102 in recurrent or metastatic cervical cancer.
Source: ESMO Congress 2026, Abstract 1244RO; Phase II study (NCT06654440).
