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The combination of the investigative PD-1 inhibitor camrelizumab plus the antiangiogenic agent apatinib led to early signals of clinical activity in patients with relapsed/refractory peripheral T-cell lymphoma, warranting further study.
The combination of the investigative PD-1 inhibitor camrelizumab plus the antiangiogenic agent apatinib led to early signals of clinical activity in patients with relapsed/refractory peripheral T-cell lymphoma (PTCL), warranting further study, according to findings of a single-center, phase 2 trial (NCT03701022) that were presented during the virtual 2020 ESMO Congress.1
The preliminary results, which were in 11 evaluable patients, showed that the objective response rate (ORR) with the combination was 36.4%, which comprised a 9.1 complete response (CR) rate and a 27.3% partial response (PR) rate.
“This preliminary data suggest that camrelizumab combined with apatinib may be a feasible option in subjects with relapsed/refractory PTCL,” Yan Xie, MD, of the Department of Lymphoma, at Peking University Cancer Hospital and Institute in Beijing, China, said in a virtual presentation during the meeting.
Currently, outcomes for patients with relapsed/refractory PTCL remain poor, and there is no standard of care for this patient population, explained Xie.
Prior research has shown that PD-1 inhibitors have some effects on relapsed/refractory peripheral T-cell lymphoma2 and that the combination of this class of agents plus antiangiogenic drugs could improve antitumor activity.3
In the single-arm, single-center, phase 2 trial, 15 patients aged 18 years and older with relapsed/refractory ALK-negative anaplastic large cell lymphoma (ALK-ALCL), PTCL not otherwise specified (NOS), extranodal natural killer/T cell lymphoma (ENKTL), or angioimmunoblastic T-cell lymphoma (AITL), were treated with the combination of camrelizumab at 200 mg on days 1 and 15 and apatinib at 500 mg on days 1 to 28 every 28 days.
To be eligible for enrollment, patients must have had an ECOG performance status of less than 2. The primary endpoint was ORR, and secondary end points were progression-free survival (PFS), duration of response, overall survival, and adverse effects (AEs).
The trial also utilized a Simon’s 2-stage disease; in the first stage, 13 patients were expected to be enrolled. It was prespecified that if the ORR exceeded 15%, the study then moved to the second stage, where 48 patients were planned to be enrolled.
The median age was 56 years (range, 24-66); 10 patients (66.7%) were male. More than one-quarter (26.4%; n = 4) of patients had PTCL NOS, 26.4% (n = 4) had AITL, 13.3% (n = 2) had ALK-ALCL, and 33.3% (n = 5) had ENKTL.
Eleven of 15 patients were evaluable for response. Further findings showed that 3 patients (27.3%) achieved stable disease (SD) and 4 patients (36.4%) had progressive disease (PD). The median PFS was 5.47 months (range, 0.97-7.37). Additionally, 2 patients with ALK-ALCL responded to treatment, which comprised 1 CR and 1 PR. Two patients with ENKTL achieved a PR; 3 patients with AITL had SD, 2 of whom continued to have SD for more than 5 months. Three patients with PTCL NOS had no response to treatment.
Regarding safety, the combination was relatively well tolerated, with most AEs being grades 1/2. Grade 1/2 AEs included rash (n = 3), neutropenia (n = 1), increased bilirubin (n = 2), hypertension (n = 1), hyperlipidemia (n = 1), pneumonia (n = 1), zoster (n = 1), hypothyroidism (n = 1), and capillary hyperplasia (n = 1). Grade 3 AEs included rash (n = 2), thrombocytopenia (n = 2), neutropenia (n = 1), and hypertension (n = 1).