2016 Hematological Malignancies

Summary

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In this registrational study in heavily pretreated patients with cHL who had failed

ASCT and brentuximab vedotin, nivolumab demonstrated:

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High ORR (IRRC-assessed ORR of 66%); investigator-assessed ORR of 73%

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Durable responses, including durable partial responses, 62% ongoing responses

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Median time to response of 2.1 months

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Acceptable safety profile, consistent with previous reports

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On May 17, 2016, the U. S. Food and Drug Administration granted accelerated

approval to nivolumab for the treatment of patients with classical Hodgkin lymphoma

(cHL) that has relapsed or progressed after autologous hematopoietic stem cell

transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris).

CheckMate 205B