Merck and NanoString Announce Clinical Research Collaboration to Develop an Immune-Related Gene Expression Assay for Use in the Development Program for KEYTRUDA® (pembrolizumab)

May 28, 2015
BUSINESS WIRE

Merck and NanoString Technologies, Inc. today announced a clinical research collaboration to develop an assay that will optimize immune-related gene expression signatures.

PRESS RELEASE

KENILWORTH, N.J. & SEATTLE--(BUSINESS WIRE)--Merck (NYSE:MRK), known as MSD outside the United States and Canada, and NanoString Technologies, Inc. (NASDAQ:NSTG) today announced a clinical research collaboration to develop an assay that will optimize immune-related gene expression signatures and evaluate the potential to predict benefit from Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), in multiple tumor types. The collaboration between NanoString Technologies, Inc., a provider of life science tools for translational research and molecular diagnostic products, and Merck, through a subsidiary, will utilize NanoString’s nCounter® Analysis System to optimize gene expression signatures as part of the clinical development program for KEYTRUDA.

“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,” said 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.”

“We are excited to work with Merck to help direct treatment with KEYTRUDA,” said Brad Gray, president and chief executive officer of NanoString Technologies. “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.”

Early Data on Immune-based Gene Expression Signatures at 2015 ASCO Annual Meeting

First-time presentations of data evaluating immune-based gene expression signatures developed using NanoString’s nCounter® Analysis System, and their correlation to patient benefit with KEYTRUDA will be presented at this year’s 51st Annual Meeting of the American Society of Clinical Oncology (May 29-June 2, 2015 in Chicago). The early data to be presented include findings in bladder cancer (Abstract #4502), advanced melanoma (Abstract #3001), gastric cancer (Abstract #3026), and head and neck cancer (Abstract #6017). These early data are based on an initial signature, the interferon-gamma response gene, which was derived from initial findings that expression of this immune response gene predicted response to KEYTRUDA in advanced melanoma patients. Additional signatures are in development based on extension of these initial findings.

About KEYTRUDA® (pembrolizumab)

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 the interaction with the receptor ligands, KEYTRUDA releases the PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response.

KEYTRUDA is indicated in the United States at a dose of 2 mg/kg administered as an intravenous infusion over 30 minutes every three weeks for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. This indication is approved under accelerated approval based on tumor response rate and durability of response. An improvement in survival or disease-related symptoms has not yet been established. Continued approval for this indication may be contingent upon verification and description of clinical benefit in the confirmatory trials.

Merck is advancing a broad and fast-growing clinical development program for KEYTRUDA with more than 100 clinical trials — across more than 30 tumor types and enrolling more than 16,000 patients – both as a monotherapy and in combination with other therapies.

About NanoString Technologies, Inc.

NanoString Technologies provides life science tools for translational research and molecular diagnostic products. The company's nCounter Analysis System has been employed in life sciences research since it was first introduced in 2008 and has been cited in over 700 peer-reviewed publications. The nCounter Analysis System offers a cost-effective way to easily profile the expression of hundreds of genes, proteins, miRNAs, or copy number variations, simultaneously with high sensitivity and precision, facilitating a wide variety of basic research and translational medicine applications, including biomarker discovery and validation. The company's technology has also been applied to diagnostic use. The Prosigna Breast Cancer Prognostic Gene Signature Assay together with the nCounter Dx Analysis System is FDA 510(k) cleared for use as a prognostic indicator for distant recurrence of breast cancer. For more information, please visit www.nanostring.com.