"Nivolumab is the first immune therapy to be used in the adjuvant setting that provides a statistically significant and clinically meaningful improvement in disease-free survival for patients with high-risk muscle-invasive urothelial carcinoma after radical surgery with curative intent, irrespective of PD-L1 status," lead author Dr. Dean F. Bajorin of Memorial Sloan Kettering Cancer Center, in New York CIty, said in a news release.
He presented the study results at the American Society of Clinical Oncology (ASCO) Genitourinary Cancers Symposium.
Cisplatin-based neoadjuvant therapy followed by radical surgery is the standard treatment for MIUC. However, some patients are not eligible for cisplatin due to factors like inadequate kidney function, Dr. Bajorin explained in his presentation.
Nivolumab is currently approved as monotherapy for treatment of platinum-resistant urothelial cancer. "To date, no immune checkpoint inhibitor has shown efficacy as adjuvant therapy in patients with MIUC at high risk for recurrence after radical surgery," he noted.
The CheckMate 274 study enrolled patients with MIUC of the bladder, ureter, or renal pelvis who underwent radical surgery with or without neoadjuvant cisplatin-based chemotherapy. Patients were at high risk for recurrence based on tumor stage at surgery; 353 patients were randomized to adjuvant nivolumab and 356 to placebo every other week for up to one year.
Median disease-free survival was significantly longer for patients taking nivolumab than for those taking placebo (median, 21.0 months vs. 10.9 months; hazard ratio, 0.70; 95% CI 0.54 to 0.89; P<0.001).
Disease-free survival was also improved with nivolumab compared with placebo in those patients with tumor PD-L1 expression >/= 1% (median not yet reached by the time of analysis with nivolumab vs 10.8 months with placebo; hazard ratio 0.53; P<0.001).
"The safety and tolerability of nivolumab monotherapy was consistent with prior reports in other tumor types including patients with metastatic UC," Dr. Bajorin told the conference. Importantly, there was "no deterioration" in health-related quality of life nivolumab, he said.
Summing up, he said nivolumab is "the first systemic immunotherapy to demonstrate statistically significant and clinically meaningful improvement in outcomes when administered as adjuvant therapy to patients with MIUC. These results support nivolumab monotherapy as a new standard of care in the adjuvant setting for patients with high-risk MIUC after radical surgery, regardless of PD-L1 status and prior neoadjuvant chemotherapy."
Providing perspective in a statement, Dr. Robert Dreicer, ASCO expert in genitourinary cancers, said, "Even with the current standard of care, surgery with or without pre-surgery chemotherapy, muscle-invasive urothelial carcinoma has a high risk of recurring. These new findings show that treating patients at highest risk of recurrence with an immunotherapy after surgery can help extend the time until the disease returns."
The study received funding from Bristol Myers Squibb in collaboration with ONO Pharmaceutical Company Ltd.
SOURCE: https://meetings.asco.org/gu/attend ASCO 2021 Genitourinary Cancers Symposium, presented February 8, 2021.
By Megan Brooks
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