(Reuters) -Pfizer and Japanese firm Astellas’ drug Padcev, combined with Merck’s 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 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 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.
(Reporting by Sriparna Roy in Bengaluru; Editing by Pooja Desai)
