FDA Approves Nivolumab for the Treatment of Classic Hodgkin Lymphoma

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.