Linking predictive biomarkers to clinical trials

BMS, Foundation Medicine focus on such markers as tumor mutational burden, microsatellite instability

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NEW YORK & CAMBRIDGE, Mass.—Bristol-Myers Squibb Co. (BMS) and Foundation Medicine announced a collaboration in late March which leverages Foundation Medicine’s genomic profiling and molecular information solutions to identify predictive biomarkers such as tumor mutational burden (TMB) and microsatellite instability (MSI) in patients enrolled across clinical trials investigating BMS’ cancer immunotherapies. Biomarkers can be used to characterize a tumor and the tumor microenvironment, which may reveal immune-related mechanisms predictive of how a patient may respond to immunotherapy.
“Cancer immunotherapy is evolving rapidly, and biopharmaceutical companies and practicing oncologists alike may benefit from a reliable, validated, comprehensive view of mutational burden and genomic alterations to make the most informed care decisions,” said Melanie Nallicheri, chief business officer and head of the Biopharma division at Foundation Medicine. “Our collaboration with Bristol-Myers Squibb highlights the potential value of our molecular information platform to the biopharma industry for its ability to inform, to reduce risk and to accelerate clinical development in this high growth and highly competitive oncology field.”
Cancer immunotherapy works by helping the immune system mount an anticancer response, a process that depends in part on the recognition of cancer-specific proteins called neoantigens. Higher levels of tumor mutations have been shown to correlate to the number of neoantigens, and therefore may help identify patients more likely to respond to cancer immunotherapies. Higher TMB can predict a greater likelihood of response and longer response duration to cancer immunotherapies in patients across a broad range of cancer types, including lung cancer, melanoma and bladder cancer. People with low TMB were highly responsive to immunotherapies if they also had mutations in the BRAF gene. People with high TMB and alterations were less likely to respond to immunotherapy, if alterations in the STK11 gene were found.
“The FoundationOne assay combines comprehensive genomic profiling with its advanced and proprietary algorithms to measure biomarkers, including TMB and MSI, without the need for whole-exome sequencing,” a Foundation Medicine spokesperson tells DDNews. “The assay sequences 315 cancer-related genes for solid tumors and identifies all classes of genomic alterations including base pair substitutions, insertions and deletions, copy number alterations and select gene rearrangements. Test results are then included in a user-friendly report that highlights the genomic alterations and provides information about targeted therapies, immunotherapies and clinical trials to better inform treatment decisions.”
“A key enabler of BMS’ immuno-oncology strategy is to leverage precision medicine to speed the selection of the most effective therapies for patients. BMS is committed to ongoing research exploring TMB and MSI as potential biomarkers to guide selection of cancer treatment and enrollment in clinical trials, which they plan to measure through the use of Foundation Medicine’s FoundationOne assay,” says Foundation Medicine.
“Translational medicine research is critical to further our understanding of cancer biology and to identify which patient populations are most likely to derive benefit from our immuno-oncology agents,” commented Dr. Fouad Namouni, head of development for oncology at Bristol-Myers Squibb. “We believe this collaboration with Foundation Medicine will help us better understand the relation of genomic approaches to immunotherapy efficacy across a number of different tumor types and immunotherapy agents.”
According to Foundation Medicine, “Foundation Medicine was selected as Bristol Myers Squibb’s partner because of its leadership in molecular information, cancer genomics and for its ability to measure tumor mutational burden and MSI from its comprehensive genomic profile (CGP) assays.” When asked about plans and future goals of the collaboration, the Foundation Medicine spokesperson tells DDNews that they are still being confirmed, as the terms of the collaboration agreement have not yet been released.
BMS also appears to be doing well generally in the financial sector, thanks to its immuno-oncology (IO) efforts. According to Seamus Fernandez, Dr. Le-Yi Wang and Richard Goss at Leerink Partners, “We believe Bristol-Myers Squibb will meet or beat first quarter consensus sales of $4.74B. [Bristol-Myers Squibb’s] unique and concentrated position in IO, together with a rapidly developing and near fully owned IO pipeline, makes it the most attractive potential strategic asset in all of large cap pharma.”

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