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 IMDC favorable/intermediate/poor risk status. In patients who received avelumab + axitinib vs sunitinib, median PFS (95% CI) was not estimable (8.1 months, not estimable) vs 11.2 months (1.6 months, not estimable) (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 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. Clinicaltrials.gov identifier: NCT02684006.
Cancer science. 2019 Dec 28 [Epub ahead of print]
Motohide Uemura, Yoshihiko Tomita, Hideaki Miyake, Shingo Hatakeyama, Hiro-Omi Kanayama, Kazuyuki Numakura, Toshio Takagi, Tomoyuki Kato, Masatoshi Eto, Wataru Obara, Hirotsugu Uemura, Toni K Choueiri, Robert J Motzer, Yosuke Fujii, Yoichi Kamei, Yoshiko Umeyama, Alessandra di Pietro, Mototsugu Oya
Osaka University Graduate School of Medicine, Department of Urology, Osaka, Japan., Niigata University Graduate School of Medicine, Department of Urology, Department of Molecular Oncology, Niigata, Japan., Hamamatsu University School of Medicine, Department of Urology, Hamamatsu, Japan., Hirosaki University Graduate School of Medicine, Department of Urology, Hirosaki, Japan., Tokushima University Graduate School of Biomedical Sciences, Department of Urology, Tokushima, Japan., Akita University Graduate School of Medicine, Department of Urology, Akita, Japan., Tokyo Women's Medical University, Department of Urology, Tokyo, Japan., Yamagata University, Faculty of Medicine, Department of Urology, Yamagata, Japan., Kyushu University, Graduate School of Medical Sciences, Department of Urology, Fukuoka, Japan., Iwate Medical University School of Medicine, Department of Urology, Morioka, Japan., Kindai University, Faculty of Medicine, Department of Urology, Osaka, Japan., Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and Brigham and Women's Hospital, Boston, MA, USA., Memorial Sloan Kettering Cancer Center, New York, NY, USA., Pfizer R&D Japan, Tokyo, Japan., Pfizer, Lombardia, Italy., Keio University School of Medicine, Department of Urology, Tokyo, Japan.