The FDA approved nivolumab for the treatment of classic Hodgkin lymphoma (cHL) for patients who have relapsed or progressed after autologous hematopoietic cell transplantation (AHCT) and post-transplantation brentuximab vedotin. The recommended dose of nivolumab is 3 mg/kg administered intravenously every two weeks until disease progression or unacceptable toxicity.
The approval was based on results from two single-arm, multi-center studies evaluating safety (n=263) and efficacy (n=95) in relapsed/refractory cHL patients treated with single-agent nivolumab. Patients had received a median five prior systematic regimens (range = 3-15 regimens) and received a median 17 doses of nivolumab (range = 3-48 doses).
The median time-to-response was 2.1 months (range = 0.7-5.7 months), and the objective response rate (primary endpoint) was 65 percent (95% CI 55-75), with 58 percent achieving partial remission and 7 percent achieving complete remission. The estimated duration of response (secondary endpoint) was 8.7 months.
Most of the patients received autoHCT (98%).
The most common any-grade treatment-related AEs (reported in ≥20% of patients) included fatigue, upper respiratory tract infection, cough, pyrexia, and diarrhea. Other common AEs (reported in ≥10% of patients) included rash, pruritus, musculoskeletal pain, nausea, vomiting, abdominal pain, headache, peripheral neuropathy, arthralgia, dyspnea, infusion-related reactions (IRRs), and hypothyroidism or thyroiditis. Serious AEs were reported in 21 percent of patients and included pneumonia, pleural effusion, pneumonitis, pyrexia, IRRs, and rash.
Nivolumab carries a warning for complications with alloHCT after nivolumab use. Transplant-related deaths have occurred and complications (including hyper-acute and severe acute graft-versus-host disease, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated AEs) should be monitored.
Source: U.S. FDA press release, May 17, 2016.