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File nameSept_18_Urology_704MOReferenceGrivas P. et al, Abst.# 704MO @ESMO? 2020TitleWhich patients benefit from Avelumab maintenance following response to 1 L chemotherapy for adv. urothelial cancer?Sub-titleAvelumab first-line (1L) maintenance + best supportive care vs best supportive alone following response or stable disease to 1L chemotherapy (CT) for advanced urothelial carcinoma: Subgroup analyses from JAVELIN Bladder 100 show benefit in all prespecified subgroupsTexte/SlidesJAVELIN Bladder 100 evaluated avelumab as maintenance therapy following response or stable disease with first-line platinum-based CT in patients with advanced urothelial cancer. Patients (n= 700) without disease progression after 4-6 cycles of CT were randomised 1:1 to receive maintenance avelumab every 2 weeks plus BSC or BSC alone. Primary endpoint was OS, assessed from randomisation Key findings of the study were presented at ASCO 2020 Virtual Meeting; Avelumab plus BSC significantly prolonged OS vs BSC alone (hazard ratio [HR] 0.69; [CI] 0.56, 0.86; 1-sided p = 0.0005). Median OS with avelumab plus BSC vs BSC alone was 21.4 vs 14.3 months, respectively. This survival benefit is robust and appears larger than the 3 months reported with the use of a check point inhibitor (CPI) in 2nd line, but is difficult to be compared in such a way since 2nd line CPI use includes patients with progression at best response duringCT (who do poor) and JAVELIN was biased due patient selection; both a higher % than expected CT-responding patients (72 % of the pts had obtained CR/PR), as well as a high % of PD-L1 +ve patients (54%), who may obtain the greatest benefit by CPI treatment. Therefore the data presented here on prespecified subgroup results are important.OS benefit with avelumab + BSC vs BSC alone was observed across prespecified subgroups, including pts with objective response (CR/PR; HR 0.69 [0.53, 0.89]) or SD (; HR 0.70 [0.46, 1.05]) as best response to 1L CTx; and pts with visceral; HR 0.82 [0.62, 1.09]) and nonvisceral mets; HR 0.54 [0.38, 0.76]). Also type of CT did not affect outcome. Of interest is the impact of PD-L1 result ; PD-L1+ve NE vs 17.1mo, HR 0.56 (0.40, 0.78), p 0.08, PD-L1 -ve 18.8 vs 13.7mo ,HR 0.86 (0.62, 1.18), p 0.68Thus the high % of PD-L1 +ve pts in JAVELIN did not polish the robust outcome , since a strong trend towards benefit (median 5 months) was also observed in PD-L1 -ve ptss. Remaining question in terms of cost-effectiveness, as well as treatment burden, is whether this OS benefit can also be obtained with a shorter duration of maintenance avelumab, like 6 or 12 months, rather than continuing until progression.Writer/EditorProf. Ronald De WIT. Erasmus MC Cancer Institute - ROTTERDAM, The Netherlands ................
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