Avelumab plus axitinib vs sunitinib for advanced renal cell carcinoma: Japanese subgroup analysis from JAVELIN Renal 101 Journal Article
| Authors: | Uemura, M.; Tomita, Y.; Miyake, H.; Hatakeyama, S.; Kanayama, H. O.; Numakura, K.; Takagi, T.; Kato, T.; Eto, M.; Obara, W.; Uemura, H.; Choueiri, T. K.; Motzer, R. J.; Fujii, Y.; Kamei, Y.; Umeyama, Y.; di Pietro, A.; Oya, M. |
| Article Title: | Avelumab plus axitinib vs sunitinib for advanced renal cell carcinoma: Japanese subgroup analysis from JAVELIN Renal 101 |
| 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. © 2019 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association. |
| Keywords: | adult; controlled study; treatment response; aged; aged, 80 and over; middle aged; major clinical study; overall survival; prednisone; clinical trial; constipation; drug tolerability; fatigue; neutropenia; sunitinib; cancer combination chemotherapy; diarrhea; drug dose reduction; drug efficacy; drug safety; drug withdrawal; hypertension; side effect; treatment duration; cancer patient; cancer staging; drug megadose; antineoplastic agent; metabolism; progression free survival; drug eruption; multiple cycle treatment; neutrophil count; gene expression; bleeding; randomized controlled trial; stomatitis; thrombocytopenia; antineoplastic combined chemotherapy protocols; continuous infusion; drug effect; renal cell carcinoma; kidney neoplasms; monoclonal antibody; alanine aminotransferase blood level; arthralgia; aspartate aminotransferase blood level; asthenia; backache; chill; coughing; drug dose escalation; fever; gamma glutamyl transferase blood level; confidence interval; alanine aminotransferase; aspartate aminotransferase; chemotherapy induced emesis; drug induced headache; malaise; antibodies, monoclonal; kidney; kidney tumor; carcinoma, renal cell; paracetamol; multicenter study; liver disease; open study; interstitial lung disease; hazard ratio; phase 3 clinical trial; hyperthyroidism; hypothyroidism; axitinib; gamma glutamyltransferase; amylase blood level; hand foot syndrome; triacylglycerol lipase blood level; epistaxis; kidney metastasis; japan; everolimus; proteinuria; immunocompetent cell; lymphocyte count; amylase; platelet count; antihistaminic agent; hemorrhoid; dysgeusia; asian continental ancestry group; triacylglycerol lipase; rhinopharyngitis; programmed death 1 ligand 1; progression-free survival; decreased appetite; dysphonia; thyroid disease; myocarditis; body weight loss; cancer prognosis; nivolumab; chemotherapy induced anemia; infusion related reaction; proctalgia; very elderly; humans; human; male; female; priority journal; article; japanese (people); avelumab; b7-h1 antigen; treatment response time; phase 3 javelin renal 101 clinical trial; cerebellum hemorrhage; chemotherapy induced nausea; patient history of nephrectomy |
| Journal Title: | Cancer Science |
| Volume: | 111 |
| Issue: | 3 |
| ISSN: | 1347-9032 |
| Publisher: | Wiley Blackwell |
| Date Published: | 2020-03-01 |
| Start Page: | 907 |
| End Page: | 923 |
| Language: | English |
| DOI: | 10.1111/cas.14294 |
| PUBMED: | 31883418 |
| PROVIDER: | scopus |
| PMCID: | PMC7060483 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 1 April 2020 -- Source: Scopus |
