GSK and Merck to study immunotherapy combo in solid tumours
pharmafile | November 3, 2015 | News story | Research and Development | GSK, Merck, immunooncology, immunotherapy, keytruda, phase I
GSK and Merck will start a Phase I clinical trial in humans to evaluate GSK’s investigational cancer drugs with the immuno-oncology drug Keytruda.
GSK will trial its immunotherapy GSK3174998 alone and in combination with Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab). The study will test the drugs in patients with locally advanced, recurrent or metastatic solid tumours that have progressed after standard treatment.
GSK3174998 is a humanised IgG1 anti-OX40 monoclonal antibody that was identified through a research collaboration with MD Anderson Cancer Center. OX40 is a tumour necrosis factor receptor expressed on the surface of activated CD4+ and CD8+ T cells. Combining with the OX40 receptor stimulates immune function, while also lowering the T cells that are sometimes found in tumours that suppress the immune system. The compound is one of several early-stage assets in GSK’s oncology pipeline.
Merck’s Keytruda is a humanised monoclonal antibody which boosts the immune system’s ability to help detect and fight tumour cells. The drug blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and may affect both tumour cells and healthy cells. It is approved in the US for lung cancer and also for melanoma, and also in the UK for advanced skin cancer.
Commenting on the new study, Axel Hoos, vice president of oncology R&D at GSK, says: “There have been meaningful advances in survival across several cancers recently, mostly based on single agent checkpoint modulatory drugs. The combination study of Keytruda with GSK’s OX40 agonist will seek to build on that progress with the aim of contributing further improvements for patients. We think combining these two agents that use different aspects of the immune system may be an important step toward achieving this goal.”
“The initiation of this phase I trial with GSK is an important step in identifying synergistic treatment combinations that can potentially enhance the activity we are seeing with KEYTRUDA as a monotherapy,” adds Dr Eric Rubin, vice president and therapeutic area head, oncology early stage development, Merck Research Laboratories. “We are looking forward to this trial progressing and to sharing the findings on the potential of the combination of Keytruda and GSK’s GSK3174998 in bringing forward improved outcomes for patients with advanced cancer.”
This latest collaboration for Merck follows last month’s announcement that it is studying Keytruda in combination with Incyte’s epacadostat for advanced or metastatic melanoma, and a collaboration with Daiichi Sankyo’s subsidiary Plexxikon to investigate immunotherapy combinations in cancer.
Joel Levy
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