Analysis may help determine whether patient selection and/or type of myeloma are factors and how these agents may be safely employed in this patient population.
KEYNOTE-183 (ClinicalTrials.gov Identifier: NCT02576977) was initiated on October 19, 2015, and had an estimated primary completion date of August 31, 2018. The purpose of the study was to compare the efficacy of pomalidomide and low-dose dexamethasone with and without pembrolizumab in patients with refractory or relapsed and refractory multiple myeloma who had undergone at least 2 lines of prior treatment.
KEYNOTE-185 (ClinicalTrials.gov Identifier: NCT02579863), also initiated on October 19, 2015, had an estimated primary completion date of August 31, 2019. This study compared lenalidomide and low-dose dexamethasone with or without pembrolizumab in newly diagnosed and treatment-naive multiple myeloma.
For both trials, the primary outcome measure was progression-free survival.
Pembrolizumab is indicated for unresectable or metastatic melanoma, metastatic non–small cell lung cancer, recurrent or metastatic head and neck squamous cell carcinoma, refractory classical Hodgkin lymphoma, locally advanced or metastatic urothelial carcinoma, and those with unresectable or metastatic microsatellite instability-high/ mismatch repair deficient cancer.
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Nearly 2 dozen clinical trials of checkpoint inhibitors are enrolling patients with relapsed and refractory multiple myeloma, smoldering multiple myeloma, following autologous hematopoietic stem cell transplantation in those at high risk for post-transplant recurrence, and asymptomatic myeloma.
- Merck provides further update on three multiple myeloma studies evaluation PEMBROLIZUMAB (pembrolizumab) in combination with pomalidomide or lenalidomide [news release]. Kenilworth, NJ: Merck; July 5, 2017. http://investors.merck.com/news/press-release-details/2017/Merck-Provides-Further-Update-on-Three-Multiple-Myeloma-Studies-Evaluating-PEMBROLIZUMAB-pembrolizumab-in-Combination-with-Pomalidomide-or-Lenalidomide/default.aspx. Accessed August 2017.
- Badros A, Hyjek E, Ma N, et al. Pembrolizumab, pomalidomide and low dose dexamethasone for relapsed/refractory multiple myeloma. Blood. 2017 May 1. doi: 10.1182/blood-2017-03-775122 [Epub ahead of print]