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 Initial data on Roche's test aimed at determining tumor mutational
burden, or TMB, was released on Friday at the European Society for
Medical Oncology (ESMO) congress in Madrid.
Immunotherapies such as Roche's Tecentriq, Merck's Keytruda and
Bristol-Myers Squibb's Opdivo have offered fresh hope to people with
deadly cancers, but they only work in a fraction of patients.
And given immunotherapies' high costs and possible serious side
effects, with British regulators having dubbed Tecentriq too
expensive, doctors want better ways to identify which patients would
benefit the most from such treatments.
Evidence shows that tumors with more mutations are more likely to
respond to immunotherapy, Roche said, adding that it hopes the new
test will improve measuring TMB, particularly when invasive biopsies
are not feasible. There are no such blood tests on the market now,
it said.
"Biomarkers will not only improve our understanding of immune
biology but will ultimately help match our therapies and
combinations to the people most likely to benefit," said Sandra
Horning, MD, the Swiss drugmaker's chief medical officer.
"This blood-based TMB assay is one example of how we and our
partners are advancing the science towards personalization of cancer
therapy.”
The biomarker data being presented at ESMO was gathered using nearly
800 plasma samples from patients in Roche's studies of its drug
Tecentriq for treating lung cancer.
Roche's trials for Tecentriq showed that lung and bladder cancer
patients responded best in instances where their tumors expressed
high levels of PD-L1, a protein that helps tumors evade immune
attack.
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Since tumor mutational burden measured by the new blood test was not
linked to PD-L1 expression levels, Foundation said, its test could
provide a whole new way to identify the best immunotherapy
candidates.
The U.S. company added that new studies are finding TMB in
indications such as breast cancer, where immunotherapy is not often
considered, meaning that the new blood test could help to expand the
range of cancers on which such treatment is used.
Roche, which owns 58 percent of Foundation, is developing 20 cancer
immunotherapy medicines across nine types of cancer, including in
combination with other drugs.
(Reporting by John Miller in Zurich and Ben Hirschler in Madrid;
Editing by Greg Mahlich and David Goodman)
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