Bristol-Myers Squibb has partnered with Illumina to develop companion diagnostics for its cancer drugs. The partners will use Illumina’s next-generation sequencing capabilities to create in vitro diagnostics (IVDs) that assess tumor mutation burden (TMB) and other potentially predictive biomarkers.
Illumina is contributing its TruSight Oncology 500 to the effort. Working with Bristol-Myers, Illumina will turn the assay into an IVD physicians can use to reveal the genetic status of their patients. Such knowledge has emerged as an key enabler of cancer care as the effect of genetic biomarkers on drug selection, response monitoring and other aspects of treatment pathways has become clear.
The partners’ initial focus on TMB matches up with Bristol-Myers’ R&D priorities. Facing a tough fight for the checkpoint inhibitor market, Bristol-Myers is running studies to show its drugs are particularly effective in patients with high TMB. The tumor DNA in these patients is more mutated than in people with low TMB, potentially making it easier for the immune system to differentiate cancer cells from healthy cells.
Bristol-Myers thinks that could enable its blockbuster checkpoint inhibitors Opdivo and Yervoy to orchestrate stronger attacks on tumors. But the biomarker-driven treatment strategy only works if physicians can assess TMB.
Diagnostic specialists, including Bristol-Myers partner Foundation Medicine, already offer tests for TMB. But Bristol-Myers clearly sees value in adding another test to physicians’ toolkits. In the longer term, the Illumina test will expand far beyond TMB to assess microsatellite instability and other biomarkers Bristol-Myers has identified as potential predictors of patient responses.
Bristol-Myers is still dealing with the fallout of not factoring predictive biomarkers into clinical trials. Notably, the company’s key Opdivo lung cancer phase 3 failed after targeting a broad patient population rather than limiting enrollment to heavy-expressors of PD-L1. Following the blow-up, Bristol-Myers hired a CSO with a history of linking treatment responses to genetic mutations.
The Bristol-Myers deal comes a week after Illumina entered into a pan-cancer companion diagnostic agreement with Loxo Oncology.