|The following article features coverage from the American Society of Hematology 2019 meeting. Click here to read more of Cancer Therapy Advisor‘s conference coverage.|
Single-agent nivolumab showed limited clinical activity in a small group of patients with relapsed/refractory peripheral T-cell lymphomas (PTCLs) who were enrolled in a phase 2 single-arm trial (ClinicalTrials.gov Identifier: NCT03075553). An interim analysis of the trial was presented at the 61st American Society of Hematology (ASH) Annual Meeting and Exposition in Orlando, Florida.
The trial enrolled 12 patients, of whom 6 had angioimmunoblastic T-cell lymphoma, 3 had PTCL, not otherwise specified, 1 had ALK-negative anaplastic large cell lymphoma, 1 had enteropathy-associated T-cell lymphoma, and 1 had hepatosplenic gamma delta T-cell lymphoma. A total of 11 patients had stage 4 disease, 11 had extranodal involvement, and 6 had prior autologous stem cell transplant. All patients received at least 1 cycle of nivolumab.
Key exclusion criteria included prior therapy with anti-PD1/PD-LI/PD-L2, or anti-CTLA antibodies, prior allogeneic stem cell transplantation, known central nervous system involvement, and interstitial lung disease or autoimmune disease.
Overall, 4 patients had a response to single-agent nivolumab, which included 2 complete responses and 2 partial responses. Patients had a median progression-free survival of 2.7 months (95% CI, 1.5-7.3), a median overall survival of 6.7 months (95% CI, 3.4-NE), and median duration of response of 1.9 months (95% CI, 1.9-5.3).
Although in the study abstract, the study authors said they observed hyperprogressive disease in 4 patients — which they defined as “dramatic” progression within 1 cycle of treatment — at the time of presentation, the researchers reported hyperprogression in only 1 patient; this was a patient with angioimmunoblastic T-cell lymphoma. In this patient, there was significant progression in tonsilar and cervical lymphadenopathy within 7 to 10 days of infusion, and based on a biopsy, the investigators concluded there was “proven involvement” with angioimmunoblastic T-cell lymphoma.
Nonhematologic grade 3 or higher adverse events were reported in 5 patients (42%), and hematologic grade 3 or higher adverse events were reported in 3 patients (25%).
Although the interim analysis met the necessary criteria to continue patient accrual, the study was halted due to the “high” number of patients with hyperprogressive disease, the “moderate” activity of the drug, and “short” duration of response, according to the abstract.
“These findings likely reflect the distinct biology of PTCL and should be considered when designing future studies using checkpoint inhibitors in these diseases,” the study authors wrote.
Bennani NN, Pederson LD, Atherton P, et al. A phase II study of nivolumab in patients with relapsed or refractory peripheral T-cell lymphoma. Presented at: 61st American Society of Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2019; Orlando, FL. Abstract 467.