News Feature | November 12, 2014

Merck Presents Anti-PD-1 Keytruda Data In 3 Cancers

By Estel Grace Masangkay

Merck announced that it will present new data for its anti-PD-1 therapy Keytruda (pembrolizumab) in advanced melanoma versus chemotherapy, in relapsed/refractory classical Hodgkin Lymphoma (cHL), and advanced triple negative breast cancer (TNBC).

Pembrolizumab is indicated in the U.S. for the treatment of patients with unresectable or metastatic melanoma for those whose disease has progressed following treatment with ipilimumab and, if BRAF V600 mutation positive, treatment with a BRAF inhibitor. The drug received accelerated approval in this indication based on tumor rate and durability of tumor response. Pembrolizumab is a humanized monoclonal antibody (mAb) that inhibits the therapeutic target PD-1 from interacting with its ligands PD-L1 and PD-L2. Through its mechanism of action, pembrolizumab induces anti-tumor immune response. The drug nailed its second FDA Breakthrough Therapy Designation last month for the treatment of advanced non-small cell lung cancer (NSCLC).

Among the data to be presented are:

  • A Randomized Controlled Comparison of Pembrolizumab (MK-3475) and Chemotherapy in Patients with Ipilimumab-Refractory Melanoma (KEYNOTE-002)
  • PD-1 Blockade with the Monoclonal Antibody Pembrolizumab (MK-3475) in Patients with Classical Hodgkin Lymphoma After Brentuximab Vedotin Failure: Preliminary Results From a Phase 1b Study (KEYNOTE-013)
  • Phase 1b Study (KEYNOTE-012) of Pembrolizumab (MK-3475) in Patients with Advanced Triple-Negative Breast Cancer

The company will present the study results respectively at the upcoming Society for Melanoma Research (SMR) 2014 International Congress taking place this month, and at the 56th American Society of Hematology (ASH) Annual Meeting and the San Antonio Breast Cancer Symposium (SABCS) taking place next month.

Dr. Roy Baynes, SVP of Global Clinical Development at Merck Research Laboratories, said, “We look forward to the first comparative data in advanced melanoma, and new data in advanced triple negative breast cancer and classical Hodgkin Lymphoma being presented. We continue to expand our immuno-oncology clinical program with KEYTRUDA both as monotherapy and in combination with other agents.”

Merck said it expects presenting anti-tumor data of Keytruda in seven different tumor types by the end of the year.