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 In its Phase II trial targeting advanced or metastatic bladder
cancer, Roche said its atezolizumab immunotherapy drug shrank tumors
in 27 percent of people who expressed medium and high levels of
PD-L1, a protein that appears to help cancers evade the immune
system.
In two separate Phase II trials targeting advanced non-small cell
lung cancer, Roche said patients getting atezolizumab lived 7.7
months longer than those who got chemotherapy. The drug also shrank
tumors in up to 27 percent of lung cancer sufferers whose disease
had progressed with other treatments and who expressed the highest
PD-L1 levels, the Swiss company said.
Roche, the largest maker of cancer drugs, is banking on atezolizumab
as its next blockbuster to keep pace with rivals including Merck &
Co. and Bristol-Myers Squibb in cancer immunotherapy development. It
hopes the drug will be on the market by late-2016 and said data from
these latest studies will help.
"We plan to submit these results to global health authorities to
bring this potential new option to people as soon as possible," said
Sandra Hornung, Roche's chief medical officer, in a statement.
Roche won 'breakthrough therapy status' for atezolizumab in February
from the U.S. Food and Drug Administration and is now calling it the
"first new therapy for bladder cancer in 30 years."
"Durable responses are not something you currently see in bladder
cancer with chemotherapy," said Thomas Buechele, Roche's head of
global medical affairs in hematology and oncology, in an interview.
Analysts said Roche is under the gun to win the blessing of
regulators, to not fall further behind rivals.
"Merck filed Keytruda in lung cancer in April
and Bristol-Myers Squibb has filed Opdivo," said Michael Leuchten of
Barclays, in a note to investors. "As such, Roche needs to follow
suit as soon as possible."
Adverse events associated with atezolizumab, including fatigue,
itching, rash and joint pain, were consistent with previous studies,
Roche said of its trials.
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The monoclonal antibody is designed to interfere with the protein
called programmed death-ligand 1, or PD-L1, that normally plays a
role in preventing autoimmunity but can be produced by some tumors,
enabling them to evade the immune system.
Roche aims to get atezolizumab to prevent PD-L1 from binding to
receptors on the surface of cancer-fighting T cells, helping
activate them to fight the tumor.
"When we inhibit PD-L1 the immune response goes up," Daniel Chen,
Roche's cancer immunotherapy franchise head, said in September.
The emergence of these so-called "checkpoint inhibitors," which
companies such as AstraZeneca and Pfizer also have in their own
trials, is being followed by oncologists seeking to keep patients
alive longer with fewer side effects.
"It is to be expected that atezolizumab, like other PD-1 and PD-L1
antibodies, will substantially change treatment strategies of
patients," Dr. Martin Reck, chief oncology physician at Germany's
Grosshansdorf Hospital, said in a statement.
(Editing by Greg Mahlich)
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