Amgen, Merck & Co. Form Immunotherapy Pact

Amgen and Merck & Co. have formed a cancer immunotherapy collaboration to support a Phase Ib/III study investigating Amgen’s Blincyto (blinatumomab) in combination with Keytruda (pembrolizumab) in patients with diffuse large B-cell lymphoma (DLBCL), which is the most common type of non-Hodgkin lymphoma (NHL). Blincyto is Amgen's CD19 bispecific T cell engager (BiTE), and Ketyruda is Merck's anti-PD-1 antibody. The study is an open-label, multicenter, randomized trial to evaluate safety and efficacy in patients with DLBCL.

The companies also announced a second immunotherapy cancer collaboration to support a Phase I/II study of AMG 820, Amgen's anti-colony-stimulating factor 1 receptor (CSF1R) antibody, in combination with Keytruda in patients with select advanced solid tumors. The open-label study is designed to evaluate safety and efficacy in patients with select advanced solid tumors, including non-small-cell lung, colorectal and pancreatic cancers.

Blincyto is a bispecific, single-chain antibody construct binding to CD19 and CD3. AMG 820 is a fully human antagonistic IgG2 monoclonal antibody that binds CSF1R and is designed to decrease tumor-associated macrophage (TAM) function. Ketyruda is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells. Ketyruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes, which may affect both tumor cells and healthy cells.

Blincyto was granted breakthrough therapy and priority review designations by the US Food and Drug Administration and is now approved in the US for the treatment of Philadelphia chromosome-negative relapsed or refractory B-cell precursor acute lymphoblastic leukemia. Keytruda is approved in the US for treating metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 as determined by an FDA-approved test with disease progression on or after platinum-containing chemotherapy. Keytruda is also indicated at the same dosing for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.

Source: Merck & Co. Inc.

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