Amgen and Merck are partnering to support a Phase 1b/3 clinical trial evaluating a cancer immunotherapy combination in patients with diffuse large B-cell lymphoma (DLBCL), the most common type of non-Hodgkin lymphoma (NHL).
The trial will assess the efficacy and safety of Blincyto, Amgen’s bispecific antibody, combined with Keytruda, Merck’s anti-PD-1 humanized monoclonal antibody. Blincyto, which was given accelerated approval by the U.S. Food and Drug Administration (FDA) for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL), is a CD19-directed CD3 T cell engager (BiTE) antibody that targets both CD19 expressed on the surface of B cells and CD3 expressed on the surface of T cells. Its immune system modulatory effect aims to help immune system cells recognize and target malignant cells, by placing T cells within reach of the targeted tumor cell, leading to its destruction. Keytruda is indicated in the U.S for the treatment of patients with metastatic PD-L1 expressing non-small cell lung cancer (NSCLC) and unresectable or metastatic melanoma, due to its ability to activate T cells through the blocking of interaction between PD-1 and its ligands. The study will be a multicenter and randomized clinical trial.
“We are pleased to enter these collaborations with Merck that build upon our growing cancer immunotherapy portfolio,” Sean E. Harper, MD, executive vice president of Amgen’s Research and Development, said in a press release.
The two companies are also collaborating on a second immunotherapy study. This study is a Phase 1-2 clinical trial of AMG 820, an anti-colony-stimulating factor 1 receptor (CSF1R) antibody from Amgen, combined with Keytruda in patients with select advanced solid tumors. The study will also be an open-label evaluation of safety and efficacy, including non-small cell lung, colorectal, and pancreatic cancers. AMG 820 is an investigational human monoclonal antibody in Amgen’s pipeline that connects CSF1R and is designed to decrease tumor-associated macrophage (TAM) function.
“We look forward to learning more about potential new combination treatment options for BLINCYTO and AMG 820 in disease areas where there remains a high unmet need,” added Dr Harper.
Said Dr. Eric Rubin, the vice president and therapeutic area head of Oncology at Merck Research Laboratories, “The combination of these immunotherapies may hold potential for patients with cancer and we look forward to partnering with Amgen to advance these trials with the hope of bringing forward new treatment combinations for patients with various types of cancer.”