How JNJ-63723283 works
JNJ-63723283 is a monoclonal antibody directed against the cell surface receptor PD-1 (programmed cell death 1) to block its function.
PD-1 is found on the surface of specialized immune cells called T-cells. A protein called PD-L1 is also found on the surface of cells and binds to PD-1 on these T-cells, working to prevent them from mistakenly attacking healthy cells. However, cancer cells can also produce PD-L1 and use it to evade being detected and destroyed by T-cells.
Once administrated, JNJ-63723283 binds to PD-1 and inhibits the interaction between PD-1 and PD-L1. This works to activate an immune response against tumor cells.
JNJ-63723283 in clinical trials
A two-part, open-label Phase 1 study (NCT02908906) is currently recruiting participants to assess the anti-tumor activity of JNJ-63723283 in people with advanced cancer, including lung, skin, kidney, bladder, and gastric/esophageal cancer.
The trial aims to find out how long JNJ-63723283 stays in and acts in the body, and how the body responds to it. It will monitor potential side effects caused by the treatment and determine the recommended dose of JNJ-63723283 to be used in a larger Phase 2 trial. Investigators will be also be looking for evidence of treatment efficacy through measures of objective response rates.
Part one is a dose-escalating phase, with JNJ-63723283 administered by intravenous infusion every two weeks. The best dose determined in that first part will be given all patients in the study’s second part.
Part two will assess the anti-tumor activity of JNJ-63723283 at the dose determined in the first part of the study in participants with advanced cancers, including non-small-cell lung cancer, melanoma, renal, bladder, small-cell lung cancer, gastric/esophageal cancer, and colorectal cancer.
About 200 cancer patients are being enrolled at trial sites in the U.S., Poland, Russia, Spain, and the U.K.; information is available by clicking on the trial’s identification number. Its estimated completion date is July 2019.
A multiphase study (EudraCT:2017-002611-34) is assessing the anti-tumor activity and safety of JNJ-63723283 in combination with Darzalex (daratumumab), compared to Darzalex alone, in people with advanced (relapsed or refractory) multiple myeloma. It is currently ongoing in the U.S., select European Union countries, Russia, Israel, and Turkey.
The first phase of the study will assess the safety of the combination of JNJ-63723283 and Darzalex compared to Darzalex monotherapy. The second phase will evaluate the overall response rate in groups of patients, and the third phase will compare progression-free survival in those treated with JNJ-63723283 in combination with Darzalex and those treated with Darzalex alone.
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