1928P - Camrelizumab plus apatinib mesylate in patients with recurrent or metastatic poorly differentiated thyroid carcinoma (PDTC) /anaplastic thyroid carcinoma (ATC): A prospective, open-label, phase II study

Background

PDTC/ATC are rare subtype cancers of thyroid cancer with a poor prognosis. Immune-checkpoint inhibitor (ICI) combined with antiangiogenic therapy have the potential for synergistic activity through modulation of the microenvironment. We report the activity and safety of camrelizumab plus apatinib mesylate in patients with recurrent or metastatic PDTC/ATC.

Methods

In this single-center, open-label, single-arm, phase II trial, we enrolled participants (≥18 years) with recurrent or metastatic PDTC/ATC who were treatment-naive to ICI, regardless of PD-ligand 1 (PD-L1) expression and BRAF gene mutation. Patients received camrelizumab 200 mg every 3 weeks and apatinib 250 mg once per day or 1-5 days every week. The primary end point was objective response rate (ORR) and disease control rate (DCR) assessed by independent radiologists per RECIST version 1.1.

Results

21 patients were enrolled from April 9, 2020 to October 26, 2023. The median age was 61.0 years (range, 47-81). 14 patients were males (66.7%) and 7 females (33.3%). The Eastern Cooperative Oncology Group performance status score was 0 in 6 patients (28.6%), 1 in 10 patients (47.6%). and 2 in 5 patients (23.8%). The pathological diagnosis was PDTC in 12 patients (57.1%), ATC in 6 patients (28.6%), and mixed subtype thyroid cancer (MSTC) involved PDTC and ATC in 3 patients (14.3%). 15 patients underwent efficacy evaluation, including 8 partial response, 1 stable disease, and 6 progression disease. The objective response rate was 53.3%, and the disease control rate was 60%. The most common adverse events were grade 1-2. No patients experienced grade 4 adverse events.

Conclusions

Camrelizumab combined with apatinib mesylate had promising antitumor activity and manageable toxicities in recurrent or metastatic PDTC/ATC.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

The authors.

Funding

Jiangsu Hengrui Pharmaceuticals Co.,Ltd.

Disclosure

All authors have declared no conflicts of interest.