The FINANCIAL — Merck, known as MSD outside the United States and Canada, announced today new study findings investigating the use of KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy, in combination with lenalidomide and low-dose dexamethasone (two commonly used treatments for multiple myeloma) in patients whose disease has progressed after at least two lines of prior therapy, including a proteasome inhibitor and an IMiD (immune modulatory drug).
The initial findings from the ongoing Phase 1 KEYNOTE-023 study showed an overall response rate (ORR) of 76 percent (n=13/17), as assessed by the International Myeloma Working Group (IMWG) 2006 Criteria. These results will be presented today at the 57th American Society of Hematology (ASH) Annual Meeting by Jesus San Miguel, M.D., Ph.D., Clínica Universidad de Navarra, Pamplona, Spain (Abstract #505). Based in part on these data, Merck has initiated two Phase 3 studies evaluating KEYTRUDA in the treatment of multiple myeloma, according to Merck.
“Many patients with multiple myeloma relapse after their initial treatment, reinforcing the need for additional treatment options,” said Dr. Jesus San Miguel. “These findings highlight the potential of combining KEYTRUDA with an IMiD and dexamethasone in patients who have multiple myeloma.”
“Our clinical program explores the potential for KEYTRUDA across broad patient populations, including in combination with other medicines,” said Roger Dansey, M.D., senior vice president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. “We are encouraged by these results, showing responses in patients who have relapsed following treatment for multiple myeloma when treated with KEYTRUDA in combination with lenalidomide and dexamethasone, and look forward to building on these data.”
Results from KEYNOTE-023 Presented at ASH
In the study with 50 heavily pre-treated patients, initial findings from 17 patients who were treated with KEYTRUDA (pembrolizumab) in combination with lenalidomide and low-dose dexamethasone demonstrated an ORR of 76 percent (n=13/17) (per IMWG 2006), including four very good partial responses (24%) and nine partial responses (53%).
Adverse events in all 50 patients were consistent with previously reported safety data for KEYTRUDA as well as lenalidomide and low-dose dexamethasone. Grade 3 or 4 treatment-related adverse events included: neutropenia (n=11), thrombocytopenia (n=4), diarrhea (n=1), fatigue (n=1), anemia (n=4), hyperglycemia (n=3) and muscle spasms (n=1). Immune-mediated adverse events included: adrenal insufficiency (n=1), hyperthyroidism (n=2), hypothyroidism (n=2), and thyroiditis (n=1). No treatment-related deaths were reported.
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