May 17 Pivotal trial results for Merck & Co
Inc's immunotherapy drug Keytruda show that it
lengthened survival by three months, or nearly 40 percent, for
patients with advanced bladder cancer who had stopped responding
The data, to be presented next month at a meeting of the
American Society of Clinical Oncology, follow last week's
announcement that rival drug Tecentriq, from Roche Holding AG
, did not improve survival when used as a second-line
treatment for bladder cancer in a pivotal trial.
The Merck drug is awaiting U.S. Food and Drug Administration
approval, but Tecentriq was approved by the agency last year,
contingent on verification of its clinical benefit. According to
the FDA approval letter, Roche, which did not respond to
requests for comment on its plans, has until December to submit
the full trial data to the agency.
Merck filed in February for FDA approval of Keytruda for
both initial and secondary treatment of advanced urothelial
cancer, the most common type of bladder cancer. Keytruda is
already approved for treating melanoma, lung cancer, head and
neck cancer, and Hodgkin lymphoma.
Merck announced in October that the second-line bladder
cancer study met its main goal and was stopped early. The
company is currently enrolling patients in a phase 3 trial of
Keytruda, combined with chemotherapy, as an initial treatment
for bladder cancer.
In addition to Tecentriq's approval for bladder cancer
patients whose disease has stopped responding to chemotherapy,
the FDA last month approved the Roche drug as an initial
treatment for people with a specific type of advanced bladder
cancer and in people whose bladder cancer progressed despite at
least one prior platinum-containing chemotherapy.
The agency has also granted contingent approval to
AstraZeneca Plc's Imfinzi, Bristol-Myers Squibb's
Opdivo and Pfizer Inc's Bavencio as second-line
bladder cancer treatments.
All five drugs are part of a new class of treatments
designed to unleash the body's immune system to fight cancer by
interfering with proteins known as PD-1 or PD-L1 that help
malignant cells evade immune attack.
Merck said data from an open-label Phase 3 trial of 542
advanced bladder cancer patients showed median survival of 10.3
months for Keytruda patients and 7.4 months for patients given
second-line chemotherapy. The study's median follow-up was 18.5
After 18 months, 36 percent of Keytruda patients were alive,
compared with 20.5 percent of chemotherapy patients, according
to research published by ASCO.
The study did not detect a difference in the length of time
patients lived without their disease getting worse.
Severe side effects were reported in 16.5 percent of the
Keytruda patients, compared with nearly half of the chemotherapy
Keytruda is being evaluated in over 30 tumor types in more
than 400 clinical trials, at least half of which combine the
drug with other cancer treatments.
(Reporting By Deena Beasley; Editing by Bill Rigby)