OncoMed initiates Phase Ib immuno-oncology combination clinical trial
pharmafile | March 18, 2016 | News story | Medical Communications, Research and Development | Merck, OncoMed, clinical trial, demcizumab, immuno-oncology, immuno-oncology combination, pembrolizumab, phase ib
OncoMed (NASDAQ: OMED) has announced the beginning of its Phase Ib clinical trial to investigate if the combination of demcizumab and pembrolizumab may act as a double blockade for cancer-induced immune suppression with potential application to a number of solid tumour cancers.
Demcizumab is a humanised monoclonal antibody that has appeared to disrupt cancer stem cell growth, reduce cancer stem cell frequency and disrupt angiogenesis in the tumour in pre-clinical trials. Marketed by Merck as Keytruda, pembrolizumab is an anti-programmed cell death (PD1) therapy.
The Phase Ib clinical trial is enrolling patients with advanced or metastatic solid tumours to receive escalating dose cohorts of demcizumab plus an approved dose of pembrolizumab. Once an optimal combination dose is established, three expansion study cohorts will be enrolled in non-small cell lung cancer (NSCLC), antii-PD1 refractory solid tumours and castrate-resistant prostate cancer.
The primary objective of the trial is to determine the safety and tolerability of the combination of demcizumab and pembrolizumab. The trial will also examine comparative pharmacokinetic profiles, incidence of antibodies against the two drugs, biomarker and immunological response, response rates and survival outcomes for patients with these forms of cancer.
Jakob Dupont, OncoMed’s chief medical officer, comments: “We’ve designed the Phase Ib study to investigate the safety profile for the demcizumab and pembrolizumab combination and to look for signals of immunological, biomarker and anti-tumour activity in advanced solid tumours. Based on our preclinical studies, we believe demcizumab may have a distinctive immune modulatory effect of decreasing monocytic myeloid-derived suppressor cells, or MDSCs, within patient tumours.
“MDSCs are important cells that prevent a patient’s immune system from fighting their cancer, even in the setting of new anti-PD1 treatments. In our preclinical studies, we have observed synergistic anti-tumour activity when combining anti-DLL4 and anti-PD1, which we attribute to their complementary mechanisms. We look forward to testing this novel combination in the clinic with the study investigators.”
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