Adjuvant nivolumab monotherapy was found to prolong disease-free survival (DFS) in patients with muscle-invasive urothelial carcinoma (MIUC) who received cisplatin prior to radical surgery , according to the results of the phase 3 CheckMate 274 trial, presented at the 2021 Genitourinary Cancers Symposium.
Neoadjuvant cisplatin-based chemotherapy is the standard of care for patients with MIUC who undergo radical surgery; however, many patients are ineligible for cisplatin.
“There is no conclusive evidence supporting adjuvant chemotherapy in patients who did not receive neoadjuvant chemotherapy and in those with residual disease after neoadjuvant cisplatin,” Dean F. Bajorin, MD, of Memorial Sloan Kettering Cancer Center in New York, New York, said during the presentation.
Therefore, the aim of the CheckMate 274 trial (NCT02632409) was to evaluate adjuvant nivolumab in patients with high-risk MIUC after radical surgery. CheckMate 274 investigators randomly assigned 353 patients with MIUC to receive either nivolumab (n=140) or placebo (n=142) for up to 1 year of adjuvant treatment. Patients who had not received prior neoadjuvant cisplatin must have been ineligible for it or refused it.
The primary end point was DFS in all randomized patients (the intention-to-treat [ITT] population) and in those with PD-L1 tumor expression of at least 1%. Non-urothelial tract recurrence-free survival (NUTRFS) in both patient populations was a secondary end point.
In the ITT population, nivolumab was found to significantly prolong DFS with a median of 21.0 months compared with 10.9 months with placebo (HR, 0.70; 95% CI, 0.54-0.89; P =.0006). Among patients with PD-L1 expression of 1% or more, the median DFS was not reached with nivolumab vs 10.8 months with placebo (HR, 0.53; 95% CI, 0.34-0.84; P =.0004).
The NUTRFS was also prolonged with nivolumab in both the ITT and PD-L1-specific populations. The median NUTRFS was 24.6 months with nivolumab compared with 13.7 months with placebo (HR, 0.72; 95% CI, 0.58-0.89) in the ITT group. In the PD-L1 group, the median NUTRFS was not reached and 10.9 months with nivolumab or placebo, respectively (HR, 0.54; 95% CI, 0.38-0.77).
Any-grade and grade 3 to 4 treatment-related adverse events (TRAEs) occurred more frequently with nivolumab at 77.5% and 17.9%, respectively, compared with 55.5% and 7.2% with placebo.
“These results support adjuvant nivolumab as a new standard of care for patients with MIUC with high risk for recurrence despite neoadjuvant chemotherapy or those ineligible for and/or declining cisplatin-based chemotherapy,” Bajorin concluded.
Disclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. For a full list of disclosures, please refer to the original study.
Bajorin DF, Witjes JA, Gschwend J, et al. First results from the phase 3 CheckMate 274 trial of adjuvant nivolumab vs placebo in patients who underwent radical surgery for high-risk muscle-invasive urothelial carcinoma (MIUC). Presented at: 2021 Genitourinary Cancers Symposium; February 11-13, 2021. Abstract 391.
This article originally appeared on Cancer Therapy Advisor