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 The trial results on patients with a gene anomaly known as NTRK
fusion, which occurs in less than 1 percent across a range of tumor
types, were presented at the annual congress of the European Society
for Medical Oncology (ESMO) in Munich on Sunday.
Germany's Bayer and U.S. partner Loxo, in turn, released data for
their rival compound larotrectinib, which slightly improved on
previous high-efficacy readings in an enlarged trial.
Traditionally, oncologists have made treatment decisions based on
where in the body a tumor started, increasingly helped by the
growing knowledge of cancer's complex genetic drivers.
Under the tumor-agnostic approach, also known as pan-tumor,
drugmakers skip the organ-of-origin perspective and regroup patients
based only on signature genetic mutations, but success in real life
will depend on the fast spread of comprehensive gene-sequencing
tools for tissue samples.
Individually, the mutations are so rare that cancer units are seen
as unlikely to run dedicated tests for each.
Roche's Foundation Medicine supplies the comprehensive kits,
competing with Thermo Fisher Scientific and Caris Life Sciences.
"It's one of the reasons we acquired Foundation Medicine, to make
this comprehensive genomic profiling routine and upfront in the
course of the disease," said Daniel O'Day, the head of Roche's
Pharmaceuticals division.
Loxo's larotrectinib pill, co-developed with Bayer, was last year
shown to shrink tumors in 75 percent of patients with the NTRK
fusion gene anomaly, occurring in the lung, pancreas, or more than a
dozen other organs.
On Sunday, the response rate to larotrectinib within an enlarged
group of 122 trial participants - up from 55 initially and now
spanning 24 tumor types - was shown to be 81 percent.
Roche said the readings from the two NTRK fusion trials were not
comparable because they are made up of different patient types.
Loxo's study, for instance, included some cancers in children, while
Roche plans to investigate those separately.
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The Roche compound is designed to tackle several oncogenic mutations
and last month, it unveiled data
https://www.roche.com/
media/releases/med-cor-2018-09-24c.htm on entrectinib pushing back
tumors in 77 percent of lung cancer patients with a mutation called
ROS1.
Merck & Co's Keytruda in May last year became the first drug to win
approval for pan-tumor use, though that remains a relatively small
market for the mega-selling drug. Bayer and Loxo are testing a
second pan-tumor drug, LOXO-195.
Roche Pharmaceutical's O'Day welcomed a wider field.
"Both things have to happen: You need genomic profiling and you need
enough targeted medicines to encourage physicians to make that
diagnosis upfront very complete. This is the world we're entering,"
he said.
Though response rates could encourage a race for more such drugs,
the need for suitable gene mutations or fusions will be a tall
order, said oncologist Ulrik Lassen of Copenhagen's Rigshospitalet,
who co-authored the larotrectinib study.
"You need to screen a lot of patients to find the needle in the
haystack and the method is complicated, costly and time-consuming.
When we get better at using these technologies, we can find more
oncogenic fusions and companies will be smart enough to find the
agents that target them."
Roche acquired entrectinib as part of its takeover deal with U.S.
cancer drug specialist Ignyta Inc for $1.7 billion, agreed in
December last year.
Immuno-oncology remains another major business area for Roche, which
also released positive results on using its Tecentriq drug in a
group of breast cancer patients with a particularly poor prognosis.
(Reporting by Ludwig Burger; Editing by Dale Hudson)
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