Merck Reports Strong Phase 1B Data For Keytruda In r/r cHL

Merck announced strong early study results for Keytruda (pembrolizumab) as treatment for relapsed/refractory classical Hodgkin Lymphoma (cHL) patients who have failed or are ineligible for transplant and whose disease has developed following treatment with brentuximab vedotin.

Pembrolizumab is a monoclonal antibody (mAb) that disrupts the interaction between PD-1 and its ligands PD-L1 and PD-L2. Through its mechanism of action, the drug triggers the release of the immune response PD-1 pathway-mediated inhibition, which includes anti-tumor immune response. Keytruda received its second breakthrough therapy designation in October from the FDA and is also being studied as a potential treatment for stomach cancer, among other indications.

The Phase 1B KEYNOTE-013 study showed that pembrolizumab achieved an overall response rate of 66 percent as measured by a response criteria assessment. Twenty-one percent of patients in the study achieved complete remission. At the time of analysis, 89 percent of responses were reported to be still ongoing.

Merck described the early findings at the press program of the upcoming 56th American Society of Hematology (ASH) Annual Meeting in San Francisco.

“These early data presented at ASH 2014 are very promising and show response rates of 66 percent with pembrolizumab in patients with classical Hodgkin Lymphoma. There are few options for patients with multiple relapsed or refractory, classical Hodgkin Lymphoma, and pembrolizumab should continue to be studied for the treatment of this cancer,” said Dr. Craig Moskowitz, clinical director of hematologic oncology at the Memorial Sloan Kettering Cancer Center. Dr. Moskowitz will also present the results in an oral session at ASH.

Dr. Alise Reicin, VP of global clinical development, oncology division at Merck Research Laboratories, said, “Response rates being observed with Keytruda in these patients support the potential role of the PD-1 pathway in blood cancers. We look forward to initiating additional studies, including a Phase 2 trial in classical Hodgkin Lymphoma in the first half of 2015.”