Unresectable stage IIC-IV melanoma progression with a max of 1 line of prior systemic treatment (not ipi), N = 168, randomized 1:1 TIL vs ipilimumab. Primary EP = PFS; Most pts had prior anti PD-1 treatment
PFS significantly improved with TIL vs ipi (Median PFS: 7.2 vs 3.1 mo). HR = 0.50, P < .001. The majority of predefined subgroups benefited from TIL
Best ORR 48.8% vs 21.4% with 20.2% CR with TIL vs 7.1 mo with ipi and CBR of 67.9% vs 39.3%
OS was not significantly improved and longer follow up is needed although the study was not powered to detect OS
All patients had grade 3 or higher AE with different TEAES attributed to CT and TIL + IL2
Significantly improved overall health-related QOL scores with TIL vs ipi
Overall, TIL significantly improved PFS compared with ipilimumab in pts with advanced melanoma as first or 2nd line treatment in a largely anti-PD-1 refractory patient population
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#ESMO22 COSMIC-313 presented by @DrChoueiri Triplet therapy with cabo/nivo/ipi vs cabo/nivo for patients with advanced TN advanced intermediate or poor-risk #RCC. Primary EP: PFS; N=855
#ESMO22#COSMIC313: Longer PFS with triplet vs doublet. mPFS NR vs 11.3 mo with benefit seen in most predefined subgroups #RCC
#ESMO22#COSMIC313 ORR 43% vs 36% with 3% CR in both arms; mDOR not reached in either arm #RCC