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MSD’s Keytruda shows promise in multiple myeloma

pharmafile | December 7, 2015 | News story | Manufacturing and Production MSD, Revlimid, dexamethasone, keytruda, multiple myeloma, pembrolizumab 

MSD has announced that it has initiated two Phase III studies based in part on the strength of early data, which found Keytruda may be effective for people with multiple myeloma.

The combination of Keytruda (pembrolizumab) with Revlimid (lenalidomide) and low-dose dexamethasone achieved a response in three-quarters of multiple myeloma patients whose disease has progressed after at least two doses of prior therapy, in a Phase 1 study.

In the study of 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 overall response rate (ORR) in 13 people, including four very good partial responses and nine partial responses.

The study results will be presented at the 57th American Society of Hematology (ASH) Annual Meeting today.

“Many patients with multiple myeloma relapse after their initial treatment, reinforcing the need for additional treatment options,” says Dr Jesus San Miguel. “These findings highlight the potential of combining Keytruda with an immunomodulatory drug and dexamethasone in patients who have multiple myeloma.”

Adverse events in all 50 patients were consistent with previously-reported safety data for Keytruda, as well as lenalidomide and low-dose dexamethasone. The most commonly-reported negative side effects were neutropenia – which occurred in 11 patients – and thrombocytopenia (platelet deficiency) – which occurred in four. No treatment-related deaths were reported.

Commenting on the early results, Roger Dansey, who is senior vice president and therapeutic area head of oncology late-stage development at Merck Research Laboratories says: “Our clinical program explores the potential for Keytruda across broad patient populations, including in combination with other medicines. 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.”

Last month, Keytruda received its third Breakthrough Designation from the US FDA for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer.

Joel Levy

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