ASCO 2018: Halted Study Reveals Risks of Pembrolizumab Treatment in Multiple Myeloma
Posted: Wednesday, June 13, 2018
The combination of pembrolizumab plus lenalidomide and low-dose dexamethasone for patients with newly diagnosed and treatment-naive multiple myeloma appears to increase the risk of death compared with lenalidomide and low-dose dexamethasone, according to the results of the KEYNOTE-185 study. Saad Zafar Usmani, MD, FACP, of the Levine Cancer Institute in Charlotte, North Carolina, and colleagues presented their findings at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago (Abstract 8010).
The phase III study, which was halted early by the U.S. Food and Drug Administration in July 2017, enrolled 640 patients with newly diagnosed, autologous stem cell transplant–ineligible multiple myeloma. A total of 301 participants had enough data to be evaluated at the time the study was suspended, including 151 in the pembrolizumab arm and 150 in the control arm. The median drug exposure for the pembrolizumab and control arms was 131 days and 162 days, respectively.
There were 19 deaths in the pembrolizumab arm, 6 attributed to disease progression and 13 due to adverse events, whereas the control arm had 9 deaths, 1 from disease progression and 8 from adverse events. Of the six treatment-related deaths reported, four were considered to be directly related to pembrolizumab. Median progression-free survival and overall survival were not reached in either arm.
Treatment with pembrolizumab was associated with a ≥ 5% higher rate of several adverse events, including constipation, pyrexia, rash, vomiting, decreased appetite, and pneumonia. Immune-mediated adverse events associated with pembrolizumab included hypothyroidism (7%), hyperthyroidism (6%), colitis (2%), and skin reactions (13%).
