893MO - An open-label, single-center, phase II, single-arm trial of camrelizumab combined with apatinib in patients with relapsed or refractory peripheral T-cell lymphoma

Background

The outcome of relapsed or refractory peripheral T-cell lymphoma (R/R PTCL) is dismal. PD1 blockade was effective in patients (pts) with R/R PTCL in a retrospective study. However, the efficacy and safety of PD1 blockade with camrelizumab combined with anti-angiogenic drug apatinib remains undefined.

Methods

In this trial (NCT03701022), pts with histologically confirmed PTCL, ECOG performance status of 0–1, and measurable lesion(s) by the Lugano 2014 criteria; those who aged 18 years or more; and those who previously received chemotherapy were eligible. PTCL included not-otherwise-specified PTCL (PTCL NOS), angioimmunoblastic T-cell lymphoma (AITL), anaplastic large-cell lymphoma (ALCL), and extranodal NK/T-cell lymphoma nasal type (ENKTL). All pts received camrelizumab 200 mg every 2 weeks and apatinib 500 mg once a day with a cycle of 28 days until the evaluation of disease progression, unaccepted toxicity, withdrawal, or death. Response to treatment was evaluated with computed tomography images by the Lugano 2014 criteria. The objective response rate (ORR) was the primary endpoint, and progression-free survival (PFS) was the secondary endpoint.

Results

A total of 15 pts were enrolled by May 1, 2020, including four pts with PTCL NOS, four pts with AITL, two pts with ALCL, and five pts with ENKTL. The median age was 56 years, 10 pts were male, and the number of previous chemotherapy regimens was 1–6 with a mean of 3. Among 11 pts with evaluable results, 36.4% achieved ORR, including one patient with complete response (CR) and three pts with partial response (PR). Three pts were evaluated with stable disease. Pts with ALCL and ENKTL had more clinical benefits compared with other subtypes; all pts with ALCL and two of three pts with evaluable ENKTL had remission (one CR and three PR). The median PFS was 5.47 months (range 0.97–7.37 months). Most adverse events (AEs) were of grade 1 to 2, and AEs of grade 3 included thrombocytopenia (10.1%), neutropenia (4.5%), hypertension (4.5%), and rash (4.5%). No grade 4 or higher AEs were observed.

Conclusions

Camrelizumab combined with apatinib showed high activity and safety, and might be a feasible option for pts with R/R PTCL.

Clinical trial identification

NCT03701022.

Editorial acknowledgement

Legal entity responsible for the study

Peking University Cancer Hospital & Institute.

Funding

Jiangsu Hengrui Medicine Co., Ltd.

Disclosure

All authors have declared no conflicts of interest.