Merck teams up with NanoString to develop gene expression assay

KENILWORTH, N.J. & SEATTLE—NanoString Technologies Inc. and Merck, known as MSD outside of the United States and Canada, have struck a clinical research collaboration for the development of an assay that can optimize immune-related gene expression signatures and evaluate the potential to predict benefit from Merck's KEYTRUDA in multiple tumor types. The collaboration, established between NanoString and Merck, through a subsidiary, will make use of NanoString's nCounter Analysis System to optimize gene expression signatures. No financial details for the collaboration were disclosed.

"We are excited to work with Merck to help direct treatment with KEYTRUDA," Brad Gray, president and CEO of NanoString Technologies, said in a press release. "New approaches in immuno-oncology, like KEYTRUDA, have the potential to transform cancer care across many different tumor types. With our nCounter technology and in-vitro diagnostic capability, NanoString is ideally positioned to address the critical challenge of matching patients to powerful new therapies. This collaboration with Merck complements our existing relationships with MD Anderson and the Cancer Immunotherapy Trials Network, and builds on our leadership position in immuno-oncology biomarker development."

Merck's KEYTRUDA (pembrolizumab) is a humanized monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2. By binding to the PD-1 receptor and blocking ligand interaction, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the body's immune response, including the anti-tumor response. The drug is indicated in the United States as an intravenous treatment for patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if their cancer is BRAF V600 mutation-positive, a BRAF inhibitor. That indication is approved under accelerated approval based on tumor response rate and response durability.

"Our commitment to advancing the science of immuno-oncology includes pursuing cutting-edge RNA and DNA approaches to identify a range of biomarkers, such as immune-related gene expression signatures, that in addition to PD-L1 expression, may help to identify patients who may be more likely to experience improved benefit with KEYTRUDA," commented Dr. Eric Rubin, vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. "Our collaboration with NanoString Technologies is an important advancement for our early-stage, immuno-oncology development program. Early data exploring the predictive value of the NanoString-derived gene expression signatures with KEYTRUDA will be presented at ASCO 2015."

In other recent advancement news for Merck's KEYTRUDA, the company announced that the European Medicines Agency's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending approval of the therapy for the treatment of advanced melanoma patients, both as a first-line therapy and in previously treated individuals. That positive opinion will now be reviewed by the European Commission for central marketing authorization in the European Union.