Novel BITE Technology Expressing Positive Impact on Prostate Cancer Patients

Release Date: 02-Nov-2020

The results for preliminary test for novel BiTEandreg; immuno-oncology therapy efficacy testing for patients with metastatic castration-resistant prostate cancer (mCRPC) who were already pre-treated were out and published at the virtual 2020 ESMO Congress. As there are number of therapies already available for the treatment of metastatic castration-resistant prostate cancer but the demand of having an efficient therapy increased as the patients were developing resistance against the hormonal therapies, radiation therapy, chemotherapy available.


The primary aim of the researchers working on this respective study was to identify and verify the safety, tolerability, pharmacokinetics, and anti-tumor activity of AMG 160, which is a targeted half-life extended BiTE (bispecific T-cell engager) immune therapy having the capability of introducing patient’s own T cells against the prostate cancer cells by binding to the protein CD3 on the T cells and some of the membrane antigens on prostate cancer cells.


For the open-label phase 1 study, researchers evaluated the efficacy of the therapy in combination with Keytruda in the patients prior to the hormone therapy. The respective study is about to get completed for dose exploration phase 1b which is followed by expansion phase armory objectives for the evaluation of the safety and tolerability of the therapy, recommended phase 2 doses, pharmacokinetics and anti-tumor activity. Out of the total patients enrolled for the study, 43 patients received more than one dose of AMG 160 monotherapy, out of which 95.3% of the patients observed adverse effects. Some of the effects that were observed in the patients were fever, CPR hypotension, nausea/vomiting and/or diarrhea.


In order to overcome the adverse effects observed in the patients, large number of strategies were employed. At the end, out of the enrolled patients, 27.6% of the patients confirmed PSA response to AMG 160. 68.3% of the patients showed PSA decline and 34.3% of the patients showed equal PSA50 reduction. 8 of the patients experienced stable disease and 3 experienced partial response. Some of the patients will be evaluated in the upcoming time period. Still, the dose optimization study is getting conducted for the therapy. It is estimated that the outcome received at the end of the study will completely transform the cancer therapeutics sector.

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