Thermo Fisher Scientific said today it will partner with Novartis and Pfizer to develop and commercialize a companion diagnostic for non-small cell lung cancer (NSCLC) across multiple drug development programs. The value of the collaboration was not disclosed.
The companion diagnostic will be a multimarker, universal next-generation sequencing (NGS) oncology test designed to assess multiple genes simultaneously from a single sample—and thus help match cancer patients with specific drug candidates.
The NGS panel will provide a platform designed to accelerate the development and registration of several new NSCLC drugs and potential new clinical indications for existing drugs, Thermo Fisher Scientific said.
“We look forward to building upon our ongoing collaboration with Novartis and Pfizer to lead the efforts in building potential novel NGS testing approaches to advance the future of cancer care,” Mark Stevenson, president of life sciences solutions for Thermo Fisher Scientific, said in a statement. “The potential to generate a paradigm shift through this agreement—from one test for one drug, to one test for multiple NSCLC therapies, represents a significant step forward in realizing the promise of precision medicine.”
According to the company, the NGS-based companion diagnostic test for NSCLC will be developed using its Ion PGM Dx System and Oncomine assays. Both the NGS platform and Oncomine reagents apply Thermo Fisher’s Ion AmpliSeq™ technology, designed to enable simultaneous sequencing of hundreds of genes, with high reproducibility and rapid turnaround time.
Thermo Fisher added that the Ion Torrent-based sequencing platform and reagents will offer comprehensive sequence analysis of a wider variety of tumor samples, including limited or compromised specimens derived from formalin-fixed paraffin-embedded (FFPE) tissue or fine needle aspirates. DNA and RNA sample input requires a few FFPE slides or 10 ng extracted nucleic acid per reaction.
“It is our hope that we will be able to take advantage of this new technology as part of our growing lung cancer portfolio to offer even better outcomes for patients,” stated Alessandro Riva, M.D., global head oncology development and medical affairs, Novartis Oncology.
Novartis Oncology’s pipeline lists four compounds under study for NSCLC, most in Phases I, II, or combination I/II. Pfizer’s pipeline includes four NSCLC compounds, led by the already-marketed c-MET-ALK-ROS1 inhibitor Xalkori (crizotinib), in registration phase in Europe for a new indication of anaplastic lymphoma kinase (ALK)-Positive 1st Line NSCLC. On October 22, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending the new indication.
Added Hakan Sakul, Ph.D., executive director and head of diagnostics, worldwide R&D, Pfizer: “We believe that this collaboration will help us get closer to our goal of ensuring that cancer patients are able to benefit from a targeted therapy associated with their tumor’s genetic profile.”