- Nivolumab has modest clinical activity in patients with refractory or relapsed peripheral T-cell lymphoma (PTCL) but associated with significant hyperprogressive disease.
Why this matters
- PTCL has worse prognosis compared with B-cell lymphomas.
- Outcomes in patients with refractory or relapsing PTCL are poor with current treatments.
- Nivolumab remains under investigation because of adverse events.
- Phase 2 study of 12 patients with refractory or relapsed PTCL, treated with nivolumab (240 mg intravenously [IV] every 2 weeks for 8 cycles followed by 480 mg IV every 4 weeks).
- The primary objective was the overall response rate (ORR) defined as the proportion of patients achieving either partial response (PR) or complete response (CR) within 12 cycles of treatment.
- Secondary objectives: PFS and OS.
- Funding: Bristol-Myers Squibb.
- The ORR was 33% (95% CI, 12.3%-63.7%).
- 1 CR was seen in patient with ALK-negative anaplastic large cell lymphoma.
- 2 PR: 1 in patient with PTCL not otherwise specified and 1 in those with enteropathy associated T-cell lymphoma.
- 1 CR was reported in patient with angioimmunoblastic T-cell lymphoma.
- Overall median PFS was 1.9 (95% CI, 1.5-8.7) months.
- Median OS was 7.9 (95% CI, 3.4-10.8) months.
- 4 patients experienced hyperprogressive disease (defined as dramatic progression within 1 cycle).
- 41.7% of patients experienced grade ≥3 nonhematologic adverse events and 25% had hematologic adverse events.
- Small study sample.