Oct 18 (Reuters) - Pfizer ( PFE ) and Japanese firm
Astellas' drug Padcev, combined with Merck's ( MRK )
Keytruda, lowered the risk of tumor recurrence, progression or
death in patients suffering from a type of bladder cancer, the
companies said on Saturday.
The late-stage trial studied patients with muscle-invasive
bladder cancer (MIBC) who were ineligible for or declined
chemotherapy with the commonly used cancer drug, cisplatin, and
were given the combination before and after surgery.
The combination therapy showed improvement in event-free
survival - which measures how long a patient remains free from
disease recurrence and other complications - with a 60%
reduction in the risk of tumor recurrence, progression or death
for patients compared to surgery alone. It also improved overall
survival, with a 50% reduction in the risk of death.
The ability of the combination to reduce the risk of death
by half in this setting was a remarkable advancement for
patients who have limited treatment options and often face poor
prognoses, said Pfizer's ( PFE ) Chief Oncology Officer Jeff Legos.
An estimated 74.7% of patients treated with the combination
were event-free at two years, compared to 39.4% who received
surgery only, the companies said.
Bladder cancer is the ninth most common cancer worldwide.
MIBC, which represents 30% of all bladder cancers, is a type of
cancer that grows into the muscle layer of the bladder wall.
Merck's ( MRK ) top-selling drug Keytruda helps the body's own
immune system fend off cancer by blocking a protein called PD-1,
while Padcev, an antibody-drug conjugate, targets specific
cancer cells without damaging healthy ones.
The combination is not currently approved to be given before
and after surgery in cisplatin-ineligible patients with MIBC.
The companies said the results would be discussed with
global health authorities for potential regulatory filings.