Recently published findings support adjuvant Opdivo (nivolumab) as a standard of care for high-risk muscle-invasive urothelial cancer, a type of bladder cancer, following radical resection.
“This three-year follow-up analysis along with the first reported [overall survival] outcomes from CheckMate 274 provides evidence for the long-term efficacy of adjuvant [Opdivo] in this setting,” researchers wrote in the study published in the Journal of Clinical Oncology. “Furthermore, this three-year length of follow-up is of particular clinical significance, as it correlates with the time when most [muscle-invasive urothelial cancer] recurrences have already happened.”
After a median follow-up of 36.1 months, disease-free survival rates stayed consistent in the intention-to-treat group and in those with a PD-L1 expression of at least 1%. In particular, patients treated with adjuvant Opdivo were 29% less likely to die from the disease returning than those who received placebo. Patients with PD-L1 expression of 1% or more were 48% less likely to die from disease compared to with those in the placebo group.
Overall survival was also improved with Opdivo versus the placebo, with a 24% reduction in the risk of death in the overall population and a 44% reduction in patients with a PD-L1 expression of 1% or greater population.
Glossary:
Adjuvant: additional treatment given after the primary treatment to reduce the risk of the disease returning.
Nonurothelial tract recurrence-free survival: the time after treatment during which a patient lives without the cancer returning outside of the bladder, ureters or renal pelvis.
Distant metastasis-free survival: the time which cancer does not spread to distant organs.
Overall survival: the time from the start of treatment when a patient with cancer is still alive.
Disease-free survival: the time after primary treatment during which a patient survives without signs or symptoms of the cancer.
In addition, the benefit in nonurothelial tract recurrence-free survival and distant metastasis-free survival was continuously observed in both patient populations. An exploratory analysis also revealed that patients with muscle-invasive bladder cancer showed continued efficacy benefits, regardless of PD-L1 status.
“These extended follow-up results including [disease-free survival] and early [overall survival] trends in [intent-to-treat] and tumor PD-L1 [greater than or equal to] 1% patients provide additional support for adjuvant [Opdivo] as a standard of care for patients with high-risk [muscle-invasive urothelial cancer] (including those with [muscle-invasive bladder cancer]) after radical resection, potentially providing an opportunity for a curative outcome,” study authors wrote.
Regarding safety for all treated patients, treatment-related side effects of any severity occurred in 78.6% of patients treated with Opdivo and 56% of patients in the placebo group. Grade 3 (severe) or 4 (life-threatening) side effects from treatment were observed in 18.2% of patients treated with Opdivo compared with 7.2% of those who received placebo.
In an exploratory analysis, patients with muscle-invasive bladder cancer experienced treatment-related side effects of any severity in 80.1% of patients treated with Opdivo and 56% of patients treated with the placebo. Grade 3 or 4 side effects from treatment occurred in 17.3% of patients in the Opdivo group compared with 5.8% of those in the placebo group.
Furthermore, the most common treatment-related side effects of any grade were itching, fatigue and diarrhea. New safety signals were not detected after the additional follow-up
A total of 709 patients were randomly assigned to receive either Opdivo or a placebo. There were 353 patients in the Opdivo group and 356 in the placebo group. Of these patients, 560 had muscle-invasive bladder cancer. This included 279 patients in the Opdivo group and 281 in the placebo group.
Eligible patients included those who either received previous neoadjuvant (given before primary treatment) cisplatin-based chemotherapy or did not undergo neoadjuvant cisplatin-based chemotherapy, and were either ineligible for or chose to decline adjuvant cisplatin-based chemotherapy. Patients must have undergone radical resection within the past 120 days and been disease free for four weeks prior to treatment assignment.
Study end goals included disease-free survival in the intent-to-treat population and in patients with a tumor PD-L1 expression of at least 1%. Both outcomes were met and, “demonstrated a statistically significant and clinical meaningful [disease-free survival] benefit in both populations,” study authors wrote.
Reference:
“Adjuvant Nivolumab in High-Risk Muscle-Invasive Urothelial Carcinoma: Expanded Efficacy From CheckMate 274” by Dr. Matthew D. Galsky, et al., Journal of Clinical Oncology.
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