An experimental Roche Holding AG drug, designed to unleash the
body's immune system to fight cancer, shrank tumors in patients
with advanced bladder cancer in a new clinical trial, the drug
maker said Monday.
Roche's Genentech unit, which developed the drug, atezolizumab,
said it plans to discuss the results with health authorities in an
effort to bring it to market as soon as possible. If approved by
regulators, it could become the first of a new wave of cancer
immunotherapies to be cleared to treat bladder cancer, and the
first new treatment for the disease in the U.S. since 1998.
Atezolizumab, which is infused intravenously, targets certain
proteins that help cancer cells escape destruction by the body's
immune system; blocking such proteins can help the immune system
fight the cancer.
Two other immunotherapy drugs are designed to accomplish the
same goal with a slightly different mechanism than the Genentech
drug: Merck & Co.'s Keytruda, and Bristol-Myers Squibb Co.'s
Opdivo. Both were introduced in the U.S. last year to treat the
deadly skin cancer melanoma, and Opdivo has since been approved to
treat a form of lung cancer. Roche is developing its drug as a
potential lung-cancer treatment too.
The immunotherapies may have potential to treat multiple other
types of cancer, including tumors of the kidney, head and neck.
Analysts believe the market for such drugs could grow into the tens
of billions of dollars in annual sales.
Each year, an estimated 74,000 new cases of bladder cancer are
diagnosed in the U.S., and about 16,000 people die from the
disease, according to the American Cancer Society. Five-year
survival rates range from 15% for advanced-stage cases to 98% for
early-stage. Standard treatments include chemotherapy.
In the new Genentech-funded study, researchers provided
atezolizumab to more than 400 patients with urothelial bladder
cancer that was locally advanced or had spread to other parts of
the body, and who had already undergone treatment with an older
drug.
The main goal of the study was to shrink tumors in a certain
percentage of patients, and Genentech said Monday the study met its
goal but didn't release the percentage. Patients experienced
adverse events consistent with what has been observed in prior
studies, when fatigue and nausea were among the more common side
effects reported.
Genentech plans to present the full data at a medical meeting
later this year. The company plans to file applications to market
the drug for bladder cancer in the U.S. and other countries, a
spokeswoman said. Last year, the FDA designated atezolizumab as a
"breakthrough therapy" for treatment of bladder cancer, a status
the agency reserves for drugs that show promise for serious
diseases. The FDA says it works closely with companies to try to
speed the development of such drugs.
Write to Peter Loftus at peter.loftus@wsj.com
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