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Avelumab plus axitinib vs sunitinib for advanced renal cell carcinoma: Japanese subgroup analysis from JAVELIN Renal 101.
- Source :
-
Cancer science [Cancer Sci] 2020 Mar; Vol. 111 (3), pp. 907-923. Date of Electronic Publication: 2020 Feb 05. - Publication Year :
- 2020
-
Abstract
- The phase 3 JAVELIN Renal 101 trial of avelumab + axitinib vs sunitinib in patients with treatment-naive advanced renal cell carcinoma (RCC) demonstrated significantly improved progression-free survival (PFS) and higher objective response rate (ORR) with the combination vs sunitinib. Japanese patients enrolled in the study (N = 67) were randomized to receive avelumab + axitinib (N = 33) or sunitinib (N = 34); 67% vs 59% had PD-L1+ tumors (≥1% of immune cells) and 6%/64%/27% vs 6%/82%/12% had International Metastatic Renal Cell Carcinoma Database Consortium (IMDC) favorable/intermediate/poor risk status. In patients who received avelumab + axitinib vs sunitinib, median PFS (95% confidence interval [CI]) was not estimable (8.1 months, not estimable) vs 11.2 months (1.6 months, not estimable) (hazard ratio [HR], 0.49; 95% CI, 0.152, 1.563) in patients with PD-L1+ tumors and 16.6 months (8.1 months, not estimable) vs 11.2 months (4.2 months, not estimable) (HR, 0.66; 95% CI, 0.296, 1.464) in patients irrespective of PD-L1 expression. Median overall survival (OS) has not been reached in either arm in patients with PD-L1+ tumors and irrespective of PD-L1 expression. ORR (95% CI) was 60.6% (42.1%, 77.1%) vs 17.6% (6.8%, 34.5%) in patients irrespective of PD-L1 expression. Common treatment-emergent adverse events (all grade; grade ≥3) in each arm were hand-foot syndrome (64%; 9% vs 71%; 9%), hypertension (55%; 30% vs 44%; 18%), hypothyroidism (55%; 0% vs 24%; 0%), dysgeusia (21%; 0% vs 56%; 0%) and platelet count decreased (3%; 0% vs 65%; 32%). Avelumab + axitinib was efficacious and tolerable in treatment-naive Japanese patients with advanced RCC, which is consistent with results in the overall population.<br /> (© 2019 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.)
- Subjects :
- Adult
Aged
Aged, 80 and over
Antibodies, Monoclonal, Humanized
Asian People
B7-H1 Antigen metabolism
Carcinoma, Renal Cell metabolism
Female
Humans
Kidney drug effects
Kidney metabolism
Kidney Neoplasms metabolism
Male
Middle Aged
Progression-Free Survival
Antibodies, Monoclonal therapeutic use
Antineoplastic Combined Chemotherapy Protocols therapeutic use
Axitinib therapeutic use
Carcinoma, Renal Cell drug therapy
Kidney Neoplasms drug therapy
Sunitinib therapeutic use
Subjects
Details
- Language :
- English
- ISSN :
- 1349-7006
- Volume :
- 111
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Cancer science
- Publication Type :
- Academic Journal
- Accession number :
- 31883418
- Full Text :
- https://doi.org/10.1111/cas.14294