High Response Rate For Nivolumab In Refractory Classical Hodgkin’s Lymphoma

Patients with classical Hodgkin’s lymphoma recurring or progressing after autologous stem-cell transplantation and brentuximab vedotin may benefit from nivolumab infusion

medwireNews: Nivolumab shows promise for patients with recurrent classical Hodgkin’s lymphoma after failure of autologous stem-cell transplantation (ASCT) and post-transplantation treatment with brentuximab vedotin, phase II trial findings indicate.

After a median of 8.9 months, 66% of the 80 patients given regular infusions of the checkpoint inhibitor (3 mg/kg over 1 hour every 2 weeks) achieved a radiological objective response, with complete remission in 9% and partial remission in 58%.

This included 72% of the 43 patients who had not responded to their most recent brentuximab vedotin treatment, say Anas Younes, from Memorial Sloan Kettering Cancer Center in New York, USA, and co-investigators

Six-month progression-free survival was achieved by 76.9% of patients and median progression-free survival was 10.0 months. The median duration of radiological response was 7.8 months but at time of analysis 62% of responses were ongoing and 37 patients were censored before they reached the median duration, prompting the researchers to suggest that “response duration and progression-free survival might increase with follow-up”.

“This finding is encouraging and might be related to the mechanism of action of PD-1 blockade, differentiating this approach from cytotoxic therapy”, they write in The Lancet Oncology.

Anas Younes et al say nivolumab was “well tolerated” and the safety profile “acceptable”. In all, 89% of patients had drug-related adverse events, with 64% experiencing grade 1 or 2 side effects, 21% grade 3 and 4% grade 4.

Lipase elevation and neutropenia were the most common grade 3 or 4 events. Serious drug-related adverse events occurred in 6% of patients, including two cases of infusion reaction, and treatment was discontinued because of autoimmune hepatitis and liver Enzyme elevations in two patients, respectively. One patient died from Epstein-Barr-positive T-cell lymphoma but this was considered unrelated to nivolumab therapy.

The author of an accompanying comment notes that the results of the current trial led to accelerated US Food and Drug Administration approval for nivolumab in patients with relapsed or progressed classical Hodgkin’s lymphoma after ASCT and brentuximab vedotin, a group with a previously unmet need.

Christian Gisselbrecht, from Institut d'Hématologie Hopital Saint Louis in Paris, France, questions whether nivolumab can also be used as a bridge to allogeneic transplantation, noting that five patients in the current study had received allogeneic transplantation and survived without graft versus host diseases, whereas four of the five such patients in the phase I study died.

He concludes: “Randomised studies comparing nivolumab and brentuximab vedotin, nivolumab alone, and the investigator's treatment choice after ASCT are warranted to confirm long-term efficacy and safety of nivolumab in patients with classical Hodgkin's lymphoma.”

References

Younes A, Santoro A, Shipp M, et al. Nivolumab for classical Hodgkin’s lymphoma after failure of both autologous stem-cell transplantation and brentuximab vedotin: a multicentre, multicohort, single-arm phase 2 trial. Lancet Oncol 2016; Advance online publication 20 July. DOI: http://dx.doi.org/10.1016/S1470-2045(16)30167-X

Gisselbrecht C. Is nivolumab an option for Hodgkin’s lymphoma? Lancet Oncol 2016; Advance online publication 20 July. DOI: http://dx.doi.org/10.1016/S1470-2045(16)30220-0

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