Merck, known as MSD outside of Canada and the United States, announced early study findings demonstrating that patients treated with pembrolizumab, the company’s investigational anti-PD-1 cancer therapy, achieved an overall response rate of 66 percent, as assessed by International Harmonization Project response criteria (n=19/29: 95% CI, 46-82). The study was conducted in transplant-ineligible and failure patients with relapsed/refractory classical Hodgkin Lymphoma (cHL) whose disease had progressed on or after treatment with brentuximab vedotin.
Complete remission was achieved in 21 percent of patients (n=6/29) in the study. At the time of analysis, 89 percent of responses were ongoing (n=17/19) with the median duration of response not yet reached (range 1+ to 185+ days).
These early findings, from the ongoing Phase 1b KEYNOTE-013 study, were described for the first time as part of the official press program at the 56th American Society of Hematology (ASH) Annual Meeting in San Francisco (ABSTRACT #290) and will be presented in an oral session on December 8 by Dr. Craig Moskowitz, Memorial Sloan Kettering Cancer Center.
“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,” said Dr. Craig Moskowitz, clinical director, Division of Hematologic Oncology, Memorial Sloan Kettering Cancer Center. “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.”
“Merck’s immuno-oncology development program spans more than 30 different types of cancer including a focus on blood cancers like classical Hodgkin Lymphoma,” said Dr. Alise Reicin, vice president, Global Clinical Development, Oncology, Merck Research Laboratories. “Response rates being observed with pembrolizumab 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.”
Early Findings for Investigational Use of Pembrolizumab in Relapsed/Refractory cHL
Data from a cohort of the ongoing Phase 1b KEYNOTE-013 study evaluated pembrolizumab monotherapy at 10 mg/kg every two weeks in patients with relapsed/refractory classical Hodgkin Lymphoma who had progressed on or after treatment with brentuximab vedotin after failure of autologous stem-cell transplant, or who were transplant-ineligible (n=29).
Median time to response was 12 weeks. In the transplant ineligible/refusal patient group, eight patients were ineligible and one patient refused transplant, respectively. The patient who refused transplant achieved a complete remission.
Adverse events were consistent with previously reported safety data for pembrolizumab. The most common treatment-related adverse events (occurring in greater than or equal to two patients) included hypothyroidism (n=3), pneumonitis (n=3), constipation (n=2), diarrhea (n=2), nausea (n=2), hypercholesterolemia (n=2), hypertriglyceridemia (n=2) and hematuria (n=2). Sixteen patients (55%) experienced at least one treatment-related adverse event of any grade. Grade 3 treatment-related adverse events occurred in a total of three patients and included axillary pain, hypoxia, joint swelling, and pneumonitis. No Grade 4 treatment-related adverse events or treatment-related deaths were reported.