Efficacy and correlative analyses of avelumab plus axitinib versus sunitinib in sarcomatoid renal cell carcinoma: post hoc analysis of a randomized clinical trial.
Date
2021-04-23ICR Author
Author
Choueiri, TK
Larkin, J
Pal, S
Motzer, RJ
Rini, BI
Venugopal, B
Alekseev, B
Miyake, H
Gravis, G
Bilen, MA
Hariharan, S
Chudnovsky, A
Ching, KA
Mu, XJ
Mariani, M
Robbins, PB
Huang, B
di Pietro, A
Albiges, L
Type
Journal Article
Metadata
Show full item recordAbstract
BACKGROUND: Among patients with advanced renal cell carcinoma (RCC), those with sarcomatoid histology (sRCC) have the poorest prognosis. This analysis assessed the efficacy of avelumab plus axitinib versus sunitinib in patients with treatment-naive advanced sRCC. METHODS: The randomized, open-label, multicenter, phase III JAVELIN Renal 101 trial (NCT02684006) enrolled patients with treatment-naive advanced RCC. Patients were randomized 1 : 1 to receive either avelumab plus axitinib or sunitinib following standard doses and schedules. Assessments in this post hoc analysis of patients with sRCC included efficacy (including progression-free survival) and biomarker analyses. RESULTS: A total of 108 patients had sarcomatoid histology and were included in this post hoc analysis; 47 patients in the avelumab plus axitinib arm and 61 in the sunitinib arm. Patients in the avelumab plus axitinib arm had improved progression-free survival [stratified hazard ratio, 0.57 (95% confidence interval, 0.325-1.003)] and a higher objective response rate (46.8% versus 21.3%; complete response in 4.3% versus 0%) versus those in the sunitinib arm. Correlative gene expression analyses of patients with sRCC showed enrichment of gene pathway scores for cancer-associated fibroblasts and regulatory T cells, CD274 and CD8A expression, and tumors with The Cancer Genome Atlas m3 classification. CONCLUSIONS: In this subgroup analysis of JAVELIN Renal 101, patients with sRCC in the avelumab plus axitinib arm had improved efficacy outcomes versus those in the sunitinib arm. Correlative analyses provide insight into this subtype of RCC and suggest that avelumab plus axitinib may increase the chance of overcoming the aggressive features of sRCC.
Collections
Subject
JAVELIN Renal 101
avelumab
axitinib
renal cell carcinoma
sarcomatoid
Antibodies, Monoclonal, Humanized
Antineoplastic Combined Chemotherapy Protocols
Axitinib
Carcinoma, Renal Cell
Humans
Kidney Neoplasms
Sunitinib
Language
eng
Date accepted
2021-03-02
License start date
2021-04-23
Citation
ESMO Open, 2021, 6 (3), pp. 100101 -
Publisher
ELSEVIER