Dr. Madduri Discusses Checkpoint Inhibitors in Myeloma

Deepu Madduri, MD
Published: Thursday, Sep 20, 2018



Deepu Madduri, MD, assistant professor, Mount Sinai Hospital, discusses the use of checkpoint inhibitors in multiple myeloma.

Agents such as ipilimumab (Yervoy), nivolumab (Opdivo), and pembrolizumab (Keytruda) have been evaluated in patients with myeloma. Madduri says that nivolumab as a single-agent has not shown much activity, though. The phase I CheckMate-039 and phase II CA204142 trials, which are exploring nivolumab-based regimens in patients with relapsed/refractory myeloma, had their partial holds lifted in December 2017. The partial holds were put in place due to safety concerns seen with pembrolizumab in the phase III KEYNOTE-183 and KEYNOTE-185 trials.

In July 2017, the FDA placed a clinical hold on the KEYNOTE-183 and KEYNOTE-185 trials. These trials evaluated pembrolizumab combined with an immunomodulatory agent—lenalidomide (Revlimid) or pomalidomide (Pomalyst)—and dexamethasone. These holds came as a result of interim results that showed an increased risk of death for the pembrolizumab arm compared with the control arm.  

Madduri says that the FDA is now requiring a control arm in any trial of checkpoint inhibitors in myeloma, as to not increase mortality.
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Deepu Madduri, MD, assistant professor, Mount Sinai Hospital, discusses the use of checkpoint inhibitors in multiple myeloma.

Agents such as ipilimumab (Yervoy), nivolumab (Opdivo), and pembrolizumab (Keytruda) have been evaluated in patients with myeloma. Madduri says that nivolumab as a single-agent has not shown much activity, though. The phase I CheckMate-039 and phase II CA204142 trials, which are exploring nivolumab-based regimens in patients with relapsed/refractory myeloma, had their partial holds lifted in December 2017. The partial holds were put in place due to safety concerns seen with pembrolizumab in the phase III KEYNOTE-183 and KEYNOTE-185 trials.

In July 2017, the FDA placed a clinical hold on the KEYNOTE-183 and KEYNOTE-185 trials. These trials evaluated pembrolizumab combined with an immunomodulatory agent—lenalidomide (Revlimid) or pomalidomide (Pomalyst)—and dexamethasone. These holds came as a result of interim results that showed an increased risk of death for the pembrolizumab arm compared with the control arm.  

Madduri says that the FDA is now requiring a control arm in any trial of checkpoint inhibitors in myeloma, as to not increase mortality.



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