Bristol Myers Squibb pulls the curtain on PhIII data to back Opdivo in the adjuvant setting
In its latest attempt to outshine Merck’s Keytruda, Bristol Myers Squibb says it has Phase III data to back Opdivo as an adjuvant treatment in patients with muscle-invasive urothelial carcinoma.
Bristol Myers Squibb says its PD-1 blockbuster came close to doubling the average length of time patients lived without disease recurrence, with a median disease-free survival 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.
The pharma heralded the results as a major step forward for immunotherapies in the adjuvant setting.
“By moving immunotherapy into earlier stages of cancer, we may have the chance to disrupt the course of the disease, reducing recurrence and leading to better outcomes for patients,” Dana Walker, VP and development program lead for genitourinary cancers, said in a statement. “Opdivo-based therapy has now shown benefit not only as an adjuvant treatment in urothelial cancer, but also in earlier-stage melanoma, esophageal and lung cancer.”
Urothelial carcinoma typically 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. More than half of patients who undergo radical resection for invasive urothelial carcinoma experience relapse.
In BMS’ Phase III CheckMate-274 trial, 709 muscle-invasive urothelial carcinoma patients with a high risk of recurrence after surgery were given either 240 mg of Opdivo or a placebo bi-weekly for up to a year.
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. This is 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.
The safety profile was consistent with previous studies in solid tumors, according to BMS. Treatment-related adverse events occurred in 77.5% of patients who received Opdivo, compared to 55.5% of patients on the placebo. Grade 3 or 4 treatment-related side effects were seen in 17.9% of patients in the treatment arm, versus 7.2% in the control arm.
The positive data represent a small victory in Opdivo’s ongoing battle with Merck’s superstar I-O Keytruda. Opdivo got its first approval in 2014, and has since tacked on a laundry list of indications, including metastatic non-small cell lung cancer, metastatic squamous cell carcinoma of the head and neck, and several others in combination with Yervoy.
But in the last few years, BMS stumbled repeatedly with an iffy development program and troubled combo alliances that left it trailing behind Merck. Back in December, BMS scuttled its program for brain tumor patients after Opdivo failed to prolong the lives of patients with newly diagnosed MGMT-positive glioblastoma multiforme.
BMS says it’s bringing the full CheckMate-274 data to the American Society of Clinical Oncology Genitourinary Cancers Symposium this Friday.
A correction has been made to the spelling of CheckMate-274.