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Cadonilimab for recurrent small cell neuroendocrine carcinoma of the cervix: a phase 2 study
Helen D Clark1, Michael Frumovitz1, Kelly M Rangel1
1The University of Texas MD Anderson Cancer Center, Department of Gynecologic Oncology and Reproductive Medicine, Houston, TX, USA.
Objective:
Small cell neuroendocrine carcinoma is a rare, aggressive histologic sub-type of cervical cancer. Although a standard frontline regimen exists, no standard highly active agent is available for recurrent disease. Single-agent anti-programmed cell death 1 therapy has also failed to demonstrate efficacy in this population; however, dual immune checkpoint blockade of programmed cell death 1 and cytotoxic T-lymphocyte-associated protein 4 has shown promising activity in high-grade neuroendocrine neoplasms. Data specific to recurrent small cell neuroendocrine cervical cancer remain sparse. We examined the safety and efficacy of cadonilimab, a bispecific antibody targeting programmed cell death 1 and cytotoxic T-lymphocyte-associated protein 4, in recurrent or metastatic small cell neuroendocrine cervical cancer.
Methods:
This was a phase 2, open-label, single-arm study of cadonilimab monotherapy in patients with recurrent or metastatic high-grade small cell neuroendocrine cervical cancer. Eligible patients received 6 mg/kg of cadonilimab on days 1 and 15 of each 28-day treatment cycle for up to 24 months. The primary objective was to estimate the 6-month progression-free survival probability using Kaplan-Meier analysis. Progression-free survival was defined as the time from treatment initiation to disease progression or death from any cause.
Results:
Among 9 patients who initiated treatment, 8 were evaluable for efficacy. One patient remained progression-free at 6 months (probability 0.125, 95% confidence interval 0.02 to 0.78). The median progression-free survival for the efficacy cohort was 2.19 months (95% confidence interval 1.84 to not available). The objective response rate was 0% (95% confidence interval 0% to 37%). Two patients experienced stable disease lasting 9.4 and 16.2 weeks, resulting in a disease control rate of 25% (2/8; 95% confidence interval 3% to 65%). One patient (1/9, 11%) experienced grade 3 fatigue. No grade 4 or 5 adverse events occurred.
Conclusions:
Cadonilimab monotherapy for recurrent or metastatic small cell neuroendocrine cervical cancer was safe; however, no objective responses were observed.
Insights
Cadonilimab, a dual immune checkpoint inhibitor, showed safety in recurrent small cell neuroendocrine cervical cancer but did not achieve objective responses. Further research is needed for effective treatments in this rare, aggressive cancer.
Area of Science:
- Gynecologic Oncology
- Immunotherapy
- Neuroendocrine Neoplasms
Background:
- Small cell neuroendocrine carcinoma is a rare, aggressive cervical cancer subtype.
- No standard effective treatment exists for recurrent or metastatic disease.
- Dual immune checkpoint blockade shows promise in other neuroendocrine neoplasms.
Purpose of the Study:
- To evaluate the safety and efficacy of cadonilimab, a bispecific antibody targeting PD-1 and CTLA-4, in patients with recurrent or metastatic small cell neuroendocrine cervical cancer.
Main Methods:
- Phase 2, open-label, single-arm study.
- Cadonilimab monotherapy administered on days 1 and 15 of each 28-day cycle.
- Primary endpoint: 6-month progression-free survival probability using Kaplan-Meier analysis.
Main Results:
- One of 8 evaluable patients (12.5%) achieved 6-month progression-free survival.
- Median progression-free survival was 2.19 months.
- Objective response rate was 0%; disease control rate was 25% (2/8 patients).
- One patient (11%) experienced grade 3 fatigue; no grade 4/5 adverse events.
Conclusions:
- Cadonilimab monotherapy demonstrated an acceptable safety profile in this patient population.
- No objective responses were observed with cadonilimab treatment.
- Further investigation into novel therapeutic strategies is warranted for recurrent small cell neuroendocrine cervical cancer.