Abstract
BackgroundThe studies IMvigor 210 cohort 2 and IMvigor211 evaluated the efficacy of atezolizumab in patients with locally advanced or metastatic urothelial cancer (mUC) upon progression to platinum-based chemotherapy worldwide. Yet, the real impact of this drug in specific geographical regions is unknown.Materials and methodsWe combined individual-level data from the 131 patients recruited in Spain from IMvigor210 cohort 2 and IMvigor211 in a pooled analysis. Efficacy and safety outcomes were assessed in the overall study population and according to PD-L1 expression on tumour-infiltrating immune cells.ResultsFull data were available for 127 patients; 74 (58%) received atezolizumab and 53 (42%) chemotherapy. Atezolizumab patients had a numerically superior median overall survival although not reaching statistical significance (9.2 months vs 7.7 months). No statistically significant differences between arms were observed in overall response rates (20.3% vs 37.0%) or progression-free survival (2.1 months vs 5.3 months). Nonetheless, median duration of response was superior for the immunotherapy arm (non-reached vs 6.4 months; p = 0.005). Additionally, among the responders, the 12-month survival rates seemed to favour atezolizumab (66.7% vs 19.9%). When efficacy was analyzed based on PD-L1 expression status, no significant differences were found. Treatment-related adverse events of any grade occurred more frequently in the chemotherapy arm [46/57 (81%) vs 44/74 (59%)].ConclusionPatients who achieved an objective response on atezolizumab presented a longer median duration of response and numerically superior 12 month survival rates when compared with chemotherapy responders along with a more favorable safety profile. PD-L1 expression did not discriminate patients who might benefit from atezolizumab.
Highlights
Urothelial cancer (UC) is a frequent disease globally with over 549,000 new diagnoses worldwide in 2018 [1]
Data are median, n (%), or n/N (%), unless otherwise specified. Once data from both studies were combined, we described the objective response rates (ORR), duration of response (DoR), progression-free survival (PFS) and overall survival (OS), of patients who received atezolizumab or chemotherapy, in the modified ITT population and according to the PD-L1 expression (Ventana PD-L1 SP142 assay) on tumour-infiltrating immune cells (IC0/1 if < 5% of tumour-infiltrating immune expressed PD-L1 or IC2/3 if ≥ 5% expressed PD-L1)
The response was missing in 4 patients, and the resulting 127 patients made up the modified ITT population for efficacy outcomes, 74 (58.3%) on atezolizumab and 53 (41.7%) on chemotherapy (67.9% vinflunine and 32.1% taxanes)
Summary
Urothelial cancer (UC) is a frequent disease globally with over 549,000 new diagnoses worldwide in 2018 [1]. The cisplatin–gemcitabine (CG) combination provides objective response rates (ORR) in the range of 50% with 12% of complete responses (CR) and a median OS of around 15 months [5] Despite these promising results, two facts have historically limited progress in advanced UC therapeutics. Most patients with metastatic disease, regardless of their response to first-line treatment, will end up progressing and the classic chemotherapy agents explored in the second line have historically provided scarce benefit with an ORR of less than 10%, a short duration of response (DoR) and a median OS of about 7 months [8]. Conclusion Patients who achieved an objective response on atezolizumab presented a longer median duration of response and numerically superior 12 month survival rates when compared with chemotherapy responders along with a more favorable safety profile. PD-L1 expression did not discriminate patients who might benefit from atezolizumab
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