Atezolizumab in locally advanced or metastatic urothelial cancer: a pooled analysis from the Spanish patients of the IMvigor 210 cohort 2 and 211 studies

Abstract

Background The 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 methods We 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. Results Full 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%)]. 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.

A Prospective Study of I.V. Vinflunine in the Treatment of Patients with Advanced or Metastatic Urothelial Carcinoma after Failure of a Platinum-containing Regimen and Biomarker Correlates

“…Recently, the IMvigor 210 study using the immune checkpoint inhibitor, atezolizumab, the median progression free survival was 2.1 months and an overall survival of 9 months [17,18]. Also, in Key Note 045 study using the drug pembrolizumab, a progression free survival of 2.1 months and an OS of 10.3 months were reported [19].…”

The combination of immune checkpoint inhibitors and antibody-drug conjugates in the treatment of urogenital tumors: a review insights from phase 2 and 3 studies

“…For patients with aUC who relapsed or progressed after platinum-based chemotherapy, atezolizumab significantly improved the prognosis. A phase 3 clinical trial (IMvigor211) [ 68 ] compared atezolizumab alone with chemotherapy (paclitaxel, docetaxel, or vinflunine). The mOS was higher in the atezolizumab group than in the chemotherapy group (8.6 months vs. 8.0 months).…”

Atezolizumab (Tecentriq) as first-line therapy in patients with metastatic urothelial carcinoma

“…Схемы на основе цисплатина ассоциируются с относительно высокой частотой объективного ответа (ЧОО) -45-50% и медианой общей выживаемости (ОВ) 15 мес. [6][7][8].…”

“…Атезолизумаб был одобрен Управлением по контролю качества пищевых продуктов и лекарственных средств США (FDA) 18 мая 2016 г. для терапии больных местнораспространенным или метастатическим уротелиальным раком с прогрессированием заболевания на фоне или после проведения ХТ с включением препаратов платины или в течение 12 мес. после получения ХТ с включением препаратов платины [8].…”

“…Однако был отмечен более длительный ответ и меньшее количество нежелательных явлений при проведении системной иммунотерапии. Кроме того, достоверно лучшие онкологические показатели были получены у пациентов с опухолевой экспрессией PD-L1 > 5% опухольинфильтрирующих иммунных клеток [8,26].…”