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KEYNOTE-183 trial of pembrolizumab in multiple myeloma: trial design and rationale
Jatin Shah, MD from the MD Anderson Cancer Center, Houston, TX provides an overview of the KEYNOTE-183 trial of pembrolizumab in combination with pomalidomide and low-dose dexamethasone in relapsed or refractory multiple myeloma (MM). The KEYNOTE-183 (NCT02576977) trial is an international Phase III trial and currently ongoing. Patients must have gone through at least two prior lines of treatment and documented progression in their last line of treatment. Further, they must have had prior exposure to an IMiD (lenalidomide and thalidomide) or a proteasome inhibitor (bortezomib, ixazomib or carfilzomib) and they must be refractory to at least on of these drugs. Patients are randomized to receive pembrolizumab and low-dose dexamethasone or pembrolizumab, low-dose dexamethasone and the checkpoint inhibitor pembrolizumab. Dr Shah explains the rationale for this trial, which is based on a trial of lenalidomide, low-dose dexamethasone and pembrolizumab (NCT02036502), which demonstrated that it is safe and feasible to combine pembrolizumab with lenalidomide and IMiDs. A different trial on the combination of pembrolizumab and pomalidomide also showed that this combination was safe and active (NCT02289222). Dr Shah explains that the combination of pembrolizumab and lenalidomide shows good response rates in relapsed/refractory MM. In the intention-to-treat (ITT) patient population, response rates are 50% with patients with stringent complete remission (CR) as well as very good partial response (VGPR). According to Dr Shah, this is the beginning of a new era in MM. Similarly, the study of pembrolizumab and pomalidomide showed high response rates. Together, these trials provide a strong rationale for the current Phase III KEYNOTE-183 trial. Dr Shah concludes with discussing the clinical relevance of checkpoint inhibitors, which cannot be assessed for MM at this point in time. However, checkpoint inhibitors have been shown the be very active in solid tumors and Hodgkin lymphoma and Dr Shah is optimistic about their use in MM. The KEYNOTE-183 trial was presented at the American Society of Clinical Oncology (ASCO) 2016 Annual Meeting, in Chicago, IL. Recorded via video conference.