TY - JOUR
T1 - Avelumab plus axitinib vs sunitinib for advanced renal cell carcinoma
T2 - Japanese subgroup analysis from JAVELIN Renal 101
AU - Uemura, Motohide
AU - Tomita, Yoshihiko
AU - Miyake, Hideaki
AU - Hatakeyama, Shingo
AU - Kanayama, Hiro omi
AU - Numakura, Kazuyuki
AU - Takagi, Toshio
AU - Kato, Tomoyuki
AU - Eto, Masatoshi
AU - Obara, Wataru
AU - Uemura, Hirotsugu
AU - Choueiri, Toni K.
AU - Motzer, Robert J.
AU - Fujii, Yosuke
AU - Kamei, Yoichi
AU - Umeyama, Yoshiko
AU - di Pietro, Alessandra
AU - Oya, Mototsugu
N1 - Funding Information:
The authors thank the patients and their families, and the investigators, co‐investigators, and study teams at each of the participating centers as well as Naoko Matsuda for data collection, Juntaro Hatsuzawa and Mana Aizawa for data analysis, and all of Pfizer R&D Japan. This trial was sponsored by Pfizer, Inc, New York, NY, USA, and is part of an alliance between Pfizer and Merck KGaA, Darmstadt, Germany. Medical writing support was provided by Shaun Rosebeck, PhD, of ClinicalThinking, Inc, Hamilton, NJ, USA, and funded by Pfizer, Inc, New York, NY, USA, and Merck KGaA, Darmstadt, Germany. This study was designed under the responsibility of Pfizer Inc and was funded by Pfizer Inc as part of an alliance between Pfizer Inc and Merck KGaA, Darmstadt, Germany. Avelumab and axitinib was provided by Pfizer Inc and Merck KGaA, Darmstadt, Germany. Pfizer Inc collected and analyzed the data and contributed to the interpretation of the study. All authors had full access to all of the data in the study and had final responsibility for the decision to submit for publication.
Funding Information:
Motohide Uemura has nothing to disclose. Yoshihiko Tomita has received honoraria from Pfizer, Astellas, Novartis, Ono, Sanofi‐Aventis and BMS; reports a consulting or advisory role for Novartis, Ono, Taiho and MSD; and reports institutional research funding from Pfizer, Ono, Takeda and Astellas. Hideaki Miyake has nothing to disclose. Shingo Hatakeyama has received honoraria from Pfizer, Astellas, Kissei, Sanofi and Ono; and reports institutional research funding from Pfizer, Astellas, Kissei, Sanofi, Ono, Bristol, Janssen and Kaneka. Hiro‐omi Kanayama has received honoraria from Pfizer and reports institutional research funding from Pfizer. Kazuyuki Numakura has received honoraria from Pfizer, Astellas, Ono, Kyowa Kirin and AstraZeneca, and research funding from the Ministry of Education (Japan; Grants‐in‐Aid for Scientific Research). Toshio Takagi has received honoraria from Novartis, Ono and BMS. Tomoyuki Kato has received honoraria from Pfizer, Novartis, Ono, Taiho, Chugai, Bayer and Astellas. Masatoshi Eto has received honoraria from Ono, BMS, Pfizer, Novartis and Bayer; reports a consulting or advisory role for Ono, BMS, Pfizer and Novartis; and has received research funding from Ono, Pfizer, Novartis and Bayer. Wataru Obara has nothing to disclose. Hirotsugu Uemura has received honoraria from Ono, BMS, AstraZeneca, MSD and Janssen; reports a consulting or advisory role for Sanofi and Ono; is a member of a speaker’s bureau for MSD, Janssen, BMS, Pfizer and Bayer; and has received research funding from Pfizer, Janssen, Taiho, AstraZeneca, Astellas, Takeda and Ono. Toni K. Choueiri reports grants received during the conduct of the study from Pfizer; personal fees received outside the conduct of the study from Agensys, Alexion, Alligent, American Society of Clinical Oncology, Analysis Group, AstraZeneca, Bayer, Bristol‐Myers Squibb, Celldex, Cerulean, Clinical Care Options, Corvus, Dana‐Farber Cancer Institute, EMD Serono, Eisai, Exelixis, Foundation Medicine, Genentech/Roche, GSK, Harborside Press, Heron, Ipsen, Kidney Cancer Association, , L‐path, , Lilly, Merck, Michael J. Hennessy Associates, National Comprehensive Cancer Network, Navinata Health, , Novartis, Peloton Therapeutics, Pfizer, PlatformQ Health, Prometheus Laboratories, Sanofi/Aventis, Seattle Genetics/Astellas and UpToDate; grants received outside the conduct of the study from AstraZeneca, Bayer, Bristol‐Myers Squibb, Calithera, Cerulean, Corvus, Eisai, Exelixis, Foundation Medicine, Genentech/Roche, GlaxoSmithKline, Ipsen, Merck, Novartis, Peloton Therapeutics, Pfizer, Prometheus Laboratories, Takeda and Tracon; and medical writing and editorial assistance provided by ClinicalThinking, Envision Pharma Group, Fishawack Group of Companies, Health Interactions and Parexel, and funded by pharmaceutical companies. Robert J. Motzer reports grants and personal fees from Pfizer, Novartis, Eisai and Genentech/Roche, personal fees from Exelixis, Merck and Incyte, and grants from BMS and GSK outside the submitted work. Yosuke Fujii is an employee of Pfizer R&D Japan. Yoichi Kamei is an employee of Pfizer R&D Japan. Yoshiko Umeyama is an employee of Pfizer R&D Japan and reports stock ownership in Pfizer. Alessandra di Pietro is an employee of Pfizer and reports stock ownership in Pfizer. Mototsugu Oya has received honoraria from Pfizer, Novartis, Bayer, Ono and BMS; reports a consulting or advisory role for Bayer; and has received research funding from Pfizer and Novartis. Kidney Cancer Journal Lancet Oncology New England Journal of Medicine
Publisher Copyright:
© 2019 The Authors. Cancer Science published by John Wiley & Sons Australia, Ltd on behalf of Japanese Cancer Association.
PY - 2020/3/1
Y1 - 2020/3/1
N2 - 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.
AB - 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.
KW - Japan
KW - avelumab
KW - axitinib
KW - phase 3 JAVELIN Renal 101 clinical trial
KW - renal cell carcinoma
UR - http://www.scopus.com/inward/record.url?scp=85079000322&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85079000322&partnerID=8YFLogxK
U2 - 10.1111/cas.14294
DO - 10.1111/cas.14294
M3 - Article
C2 - 31883418
AN - SCOPUS:85079000322
SN - 1347-9032
VL - 111
SP - 907
EP - 923
JO - Cancer science
JF - Cancer science
IS - 3
ER -
