Results of the mid-stage trial could help make the case that the
drug, Tecentriq, should become the first option therapy of choice
for patients with metastatic bladder cancer, according to a
researcher leading the study.
Known chemically as atezolizumab, Tecentriq last month won U.S.
approval for bladder cancer that had progressed following
chemotherapy, becoming the first new drug for the disease in 30
years.
The latest study tested the Roche drug, given by injection every
three weeks, in 119 patients deemed ineligible for standard
cisplatin chemotherapy.
Nearly a quarter of the patients experienced at least 30 percent
tumor shrinkage with no new lesions, including 7 percent who had no
sign of cancer.
Dr. Arjun Balar of New York University Langone Medical Center, the
study's lead investigator, said he did not expect to see complete
responses in these patients, most of whom had seen their cancer
spread to the lungs, liver or bones.
"In my opinion it absolutely needs to be considered as a potential
new first-line standard of care," said Balar, who presented the data
at the American Society of Clinical Oncology scientific meeting in
Chicago.
Tecentriq belongs to a new class of biotechnology drugs called PD-L1
inhibitors that help the immune system fight cancer by blocking a
mechanism tumors use to evade detection. They are similar to PD-1
inhibitors from Merck & Co and Bristol-Myers Squibb that have
extended survival in advanced melanoma and lung cancer patients.
At a list price of $12,500 per month, Tecentriq costs roughly the
same as Keytruda and Bristol's rival Opdivo.
After an average follow-up of 14.4 months into treatment, 75 percent
of the responders had not experienced disease progression.
Researchers estimate the median overall survival will be 14.8
months.
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The typical survival prognosis for advanced bladder cancer patients
who cannot receive cisplatin is 9 to 10 months, researchers said.
The drug is far less toxic than chemotherapy, researchers said, with
6 percent of patients discontinuing therapy due to side effects. Far
more patients typically discontinue chemotherapy, and many refuse it
altogether.
Dr. David Nanus, who was not involved in the study, said oncologists
see many older patients who cannot tolerate chemotherapy and many
with impaired kidney function not eligible to benefit from cisplatin.
"It's extremely exciting for that group of patients to see these
durable remissions," said Nanus, chief of hematology and oncology at
Weill Cornell Medicine and New York-Presbyterian Hospital.
An estimated 77,000 people in the United States will be diagnosed
with bladder cancer this year, making it the fifth most common
cancer in adults.
(Reporting by Bill Berkrot; Editing by Diane Craft and Bill Rigby)
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