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 Thirty seven percent of patients in a closely watched clinical trial
who received Tecentriq, Avastin and chemotherapy reached the
one-year mark without their cancer progressing (PFS), according to
data released on Thursday.
For patients getting only Avastin and chemotherapy, that fell to 18
percent.
Roche's announcement in November that its Impower 150 trial had
broadly succeeded in first-line lung cancer patients helped spur a
one-day, $12 billion rally in the Basel-based drugmaker's market
capitalisation.
Thursday's release of specific numbers at a European Society for
Medical Oncology meeting in Geneva could further fan investor
optimism that the Swiss drugmaker is gaining on rivals Merck & Co
and Bristol-Myers Squibb.
Roche Chief Executive Severin Schwan sees an opportunity to
leap-frog ahead as competitors still await their own lung cancer
combination trial results.
"This is very, very promising," Dr Solange Peters, the head of
Medical Oncology at the Centre Hospitalier Universitaire Vaudois in
Lausanne, Switzerland, said on the latest results.
"Doubling PFS (progression-free survival) at one year is something
we have not seen with any targeted therapy in unselected patients to
date."
In a second significant trial result, Roche also released positive
interim data from its recently approved haemophilia drug Hemlibra
dosed every four weeks, saying the results were consistent with
previous studies of the medicine dosed once a week or every two
weeks.
Roche said it would submit the results from both studies to
regulatory authorities around the world.
The Swiss company's shares rose more than 1 percent in Zurich.
Analysts said the "highly significant" risk reduction from the study
will help cement Tecentriq as a strong competitor to Merck's
Keytruda.
"We see the Impower 150 outcomes sufficient for Roche to submit a
robust data package to the health authorities and very likely obtain
a marketing authorization in the U.S. by mid-2018," wrote Bruno
Bulic, a Baader Helvea analyst with a "buy" rating on Roche shares.
Roche is counting on $150,000-per-year Tecentriq to help replace
revenue from its $20 billion-per-year trio of Avastin, Herceptin and
Rituxan whose patents have expired or will shortly, exposing them to
cheaper competition.
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According to estimates collected by Reuters, Tecentriq annual sales
are seen topping $4.6 billion by 2023.
Lung cancer is easily the biggest oncology market, with about
220,000 people in the United States due to be diagnosed this year
and 155,000 seen dying from the disease often caused by smoking.
In Roche's 1,202-patient study, patients getting Roche's
immunotherapy survived an average of 8.3 months without their
disease getting worse, only modestly better than the PFS of 6.8
months for those getting chemotherapy and Avastin.
Still, analysts focused more on the 38 percent reduction in risk of
disease progression or death in the Tecentriq group, well within the
range they have said would signify a robust result.
OVERALL SURVIVAL
For a set of patients who expressed a specific biomarker called "Teff"
that Roche is exploring to help identify people who may respond
best, the results were more robust, with a 49 percent risk reduction
and PFS at 11.3 months for the Tecentriq group versus 6.8 months.
Roche, which said serious adverse events were seen in 25.4 percent
of patients getting the Tecentriq combination compared with 19.3
percent in the Avastin-chemo group, is still awaiting Impower 150's
overall survival data in the first half of 2018.
Still, the trial's head, Dr Martin Reck of Germany's Lung Clinic
Grosshansdorf, said those numbers "look encouraging".
Tecentriq is already approved in bladder cancer treatment and for
lung cancer patients who have failed chemotherapy.
(Reporting by John Miller; Editing by Ben Hirschler/Mark
Potter/Susan Fenton)
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