Bristol Myers' Opdivo scores priority review in common bladder cancer, marking latest win in PD-1 battle with Keytruda
Two months after Bristol Myers Squibb announced Opdivo nearly doubled the average length of time patients with a common bladder cancer lived without disease recurrence, regulators have said they’ll give the PD-1 blockbuster an expedited look.
The FDA has granted priority review to Opdivo as an adjuvant treatment in muscle-invasive urothelial cancer, Bristol Myers said on Friday, marking the latest win in the pharma’s bid to outshine Merck’s superstar I/O Keytruda. The agency tapped Sept. 3 for a PDUFA date.
Urothelial carcinoma frequently begins in the cells that line the inside of the bladder, but can also occur in other parts of the urinary tract, including the ureters and renal pelvis. While the majority of cases are diagnosed early, the chance of recurrence and disease progression is high.
“After patients undergo surgery for muscle-invasive urothelial carcinoma, they continue to face uncertainties given the high rate of disease recurrence and the lack of safe and effective treatment options,” Dana Walker, Bristol Myers’ VP and development lead for genitourinary cancers, said in a statement. “We look forward to working with the FDA towards the goal of bringing the first adjuvant immunotherapy option to these patients in the U.S.”
The FDA’s decision was based on results from the Phase III CheckMate -274 trial, in which Opdivo came close to doubling disease-free survival, with a median of 21 months in the treatment arm and 10.9 months in the placebo arm. And for patients whose tumors express PD-L1 ≥1%, Opdivo reduced the risk of disease recurrence or death by 47%, according to BMS.
In addition to meeting both primary endpoints — disease-free survival in all patients and in the subset whose tumors expressed PD-L1 ≥1% — Opdivo met key secondary endpoints, including the time patients lived without recurrence outside the bladder, ureters or renal pelvis (also called non-urothelial tract recurrence-free survival, or NUTRFS.) Those given Opdivo achieved a median NUTRFS of 24.6 months compared to 13.7 months for those who got the placebo.
Since snagging its first approval in 2014, Opdivo has built up a long list of indications, ranging from metastatic non-small cell lung cancer to metastatic squamous cell carcinoma of the head and neck, and several others in combination with Yervoy. But setbacks over the last few years have left it trailing behind Merck. While Keytruda raked in $14.4 billion in sales last year, Opdivo took home just under $7 billion.
Back in December, BMS agreed to stop marketing Opdivo in third-line-or-later small-cell lung cancer after confirmatory trials for an accelerated nod failed to show benefit in extending patients’ lives. And just a week before that, the pharma did the same for its program for brain tumor patients after Opdivo failed to prolong the lives of patients with newly diagnosed MGMT-positive glioblastoma multiforme.
Earlier this year, though, Opdivo picked up another priority review to treat first-line patients with advanced or metastatic gastric cancer, gastroesophageal junction cancer or esophageal adenocarcinoma in combination with chemotherapy. The agency set an action date of May 25 for that application.
Keytruda scored an approval in non-muscle-invasive bladder cancer last January.