A recent diagnostics acquisition by Roche would seem to indicate the Swiss pharmaceutical giant has an idea of the future of oncology drug development.
Roche spent $2.4 billion last month to acquire the remainder of diagnostics maker Foundation Medicine, in which it bought a majority stake for $1 billion in 2015. And if a report released Monday is correct, it would indicate the drugmaker has tapped into what will become a significant market.
The report, from ResearchAndMarkets, forecasts that the global market for cancer biomarkers will reach $20.48 billion by 2022, compared with last year’s $11.53 billion value. The market is classified into diagnostics, research and development, prognostics, risk assessment and other applications, based on biomarkers segmented into protein, genetic and others. Diseases included in the analysis include leukemias and non-Hodgkin’s lymphomas – both blood cancers – and several solid tumor cancers.
The Roche news and the market forecast arrive as biomarker-driven drug development has become a hot topic in oncology. Last year, Merck & Co.’s PD-1 checkpoint inhibitor Keytruda became the first drug to win Food and Drug Administration approval for use in cancers based on biomarkers rather than tumor type, when the agency expanded its label to include cancers that display abnormalities known as microsatellite instability-high (MSI-H) and mismatch repair deficiency (dMMR). And on May 29, the FDA accepted a New Drug Application from Loxo Oncology for the drug larotrectinib, which targets genetic mutations known as NTRK fusions, regardless of tumor type. Data presented at the American Society of Clinical Oncology’s annual meeting in Chicago for another Loxo drug, LOXO-292, showed nearly three-quarters of patients with RET fusions responding to treatment.
Foundation’s focus is next-generation sequencing, or NGS, which tests patients’ tumors for a large panel of potentially targetable genetic mutations, often numbering in the hundreds. NGS will be crucial for biomarker-driven drugs, especially those that target that can be rare. In May, Merck and Foundation announced a collaboration to develop an NGS-based test for detecting MSI-H and dMMR, whose frequency ranges from 22-33 percent in endometrial cancers to 2 percent or less in skin and breast cancers.
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