In the THOR trial (NCT03390504) Cohort 1, erdafitinib demonstrated significantly prolonged overall survival (OS) (median 12.1 versus 7.8 months) and reduced risk of death by 36% (hazard ratio 0. 64, P = 0.005) compared with chemotherapy in metastatic urothelial carcinoma (mUC) patients with FGFR alterations who progressed after ≥ 1 prior treatments, including anti-PD-(L)1. There have been no reports of the Japanese subgroup results yet.
THOR Cohort 1 randomized patients to erdafitinib once daily or docetaxel/vinflunine once every 3 weeks. Primary endpoint was OS. Secondary endpoints included progression-free survival (PFS) and objective response rate (ORR). No specific statistical power was set for this Japanese subgroup analysis.
Of 266 patients randomized, 27 (14 erdafitinib; 13 chemotherapy) were Japanese. Baseline characteristics were generally similar between treatments and to the overall population, except for more males, lower body weight, and more upper tract primary tumors among Japanese patients. Compared with chemotherapy, erdafitinib showed improved OS (median 25.4 versus 12.4 months), PFS (median 8.4 versus 2.9 months) and ORR (57.1% versus 15.4%). Any grade treatment-related adverse events (AEs) occurred in all patients from both arms but Grade 3/4 AEs and AEs leading to discontinuation were lower in the erdafitinib arm. No new safety signals were observed in the Japanese subgroup.
In the Japanese subgroup, erdafitinib showed improved survival and response compared to chemotherapy, with no new safety concerns. These results support erdafitinib as a treatment option for Japanese mUC patients with FGFR alterations, and early FGFR testing after diagnosis of mUC should be considered.
International journal of clinical oncology. 2024 Jul 17 [Epub ahead of print]
Nobuaki Matsubara, Yuji Miura, Hiroyuki Nishiyama, Rikiya Taoka, Takahiro Kojima, Nobuaki Shimizu, Jason Hwang, Tatsuya Ote, Ryo Oyama, Kiichiro Toyoizumi, Sutapa Mukhopadhyay, Spyros Triantos, Kris Deprince, Yohann Loriot
Department of Medical Oncology, National Cancer Center Hospital East, 6-5-1 Kashiwanoha, Kashiwa, Chiba, 277-8577, Japan. ., Department of Medical Oncology, Toranomon Hospital, 2-2-2 Toranomon, Minato-ku, Tokyo, 105-8470, Japan., Department of Urology, Institute of Medicine, University of Tsukuba, 1-1-1 Tennodai, Tsukuba, Ibaraki, 305-8575, Japan., Department of Urology, Faculty of Medicine, Kagawa University, 1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa, 761-0793, Japan., Department of Urology, Aichi Cancer Center Hospital, 1-1 Kanokoden, Chikusa-ku, Nagoya, Aichi, 464-8681, Japan., Department of Urology, Gunma Prefectural Cancer Center, 3-39-22 Showa-machi, Maebashi, Gunma, 371-8511, Japan., Department of Medical Affairs, Janssen Pharmaceutical K.K, 5-2-3 Nishikanda, Chiyoda-ku, Tokyo, 101-0065, Japan., Oncology Clinical Development Department, Clinical Science Division, Research and Development, Janssen Pharmaceutical K.K, 5-2-3 Nishikanda, Chiyoda-ku, Tokyo, 101-0065, Japan., Research and Development, Janssen Pharmaceutical K.K, 5-2-3 Nishikanda, Chiyoda-ku, Tokyo, 101-0065, Japan., Statistics and Decision Sciences, Research and Development, Janssen Pharmaceutical K. K, 5-2-3 Nishikanda, Chiyoda-ku, Tokyo, 101-0065, Japan., Janssen Research and Development, 920 US Highway 202 S, Raritan, NJ, 08807, USA., Janssen Research and Development, 1400 McKean Road, Spring House, PA, 19477, USA., Janssen Research and Development, Turnhoutseweg 30, 2340, Beerse Anterwerpen, Belgium., Department of Cancer Medicine, INSERM U981, Gustave Roussy, Universite Paris-Saclay, 94800, Villejuif, France.