The company provided cost-effectiveness estimates for nivolumab compared with best supportive care but did not provide cost-effectiveness estimates comparing nivolumab with adjuvant chemotherapy. The CheckMate 274 trial only included a placebo (best supportive care) comparator arm. It concluded that nivolumab is a valued treatment option for people with resected high-risk muscle-invasive urothelial cancer.ģ.2 The final NICE scope included adjuvant chemotherapy and best supportive care (active monitoring) as comparators. The committee acknowledged that nivolumab is the first adjuvant immunotherapy available for resected high-risk muscle-invasive urothelial cancer. The committee considered that adjuvant treatment with nivolumab after radical resection may address an unmet need. The clinical experts explained that immunotherapy at an early stage has the potential to significantly improve outcomes and increase the number of people whose cancer is cured. The clinical and patient experts noted that nivolumab was generally well tolerated and that the short infusion time of the treatment compared with chemotherapy was an advantage.
This is because it allows them to spend more time with their families and enjoy a good quality of life, and relieves stress on carers. The patient experts explained that extending the duration of disease-free survival is important to patients. They explained that for some people platinum‑based chemotherapy is not suitable or tolerated, and some people are unwilling to have it. The patient experts explained that there is a high unmet need in this area and a new treatment option at this part of the pathway was welcomed. High risk is defined by the MIUC pathologic staging criteria in section 5.1 of nivolumab's summary of product characteristics. Despite resection, the disease can recur. Some people have platinum‑based chemotherapy before the surgery (neoadjuvant treatment) and would not be eligible for adjuvant treatment with platinum‑based chemotherapy. Standard care after radical resection is platinum‑based chemotherapy (adjuvant treatment) or best supportive care. Abstract 391.3.1 Muscle-invasive urothelial cancer can have a significant impact on people and their families and carers.
Presented at: 2021 Genitourinary Cancers Symposium February 11-13, 2021. 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). Read more of our coverage of the 2021 Genitourinary Cancers Symposium by visiting the conference page.īajorin DF, Witjes JA, Gschwend J, et al. For a full list of disclosures, please refer to the original study. “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.ĭisclosures: Some of the study authors disclosed financial relationships with the pharmaceutical industry and/or the medical device industry. 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).Īny-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. 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. The NUTRFS was also prolonged with nivolumab in both the ITT and PD-L1-specific populations. 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). 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). Non-urothelial tract recurrence-free survival (NUTRFS) in both patient populations was a secondary end point. The primary end point was DFS in all randomized patients (the intention-to-treat population) and in those with PD-L1 tumor expression of at least 1%. Patients who had not received prior neoadjuvant cisplatin must have been ineligible for it or refused it. 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. Therefore, the aim of the CheckMate 274 trial ( NCT02632409) was to evaluate adjuvant nivolumab in patients with high-risk MIUC after radical surgery.
0 kommentar(er)
