208O - Asian subgroup analysis of the THOR phase III study: Erdafitinib versus chemotherapy in patients with advanced or metastatic urothelial cancer and selected fibroblast growth factor receptor alterations

Background

Treatment options for locally advanced/metastatic urothelial cancer (la/mUC) after progression on anti-programmed death-ligand 1 (anti-PD-[L]1) therapy are limited. Erdafitinib showed survival benefit over chemotherapy in a global population of patients with la/mUC and selected fibroblast growth factor receptor alterations (FGFRalt) who progressed after 1 or 2 lines of prior treatment, including anti-PD-(L)1 therapy (cohort 1) in a randomised phase 3 study (THOR; NCT03390504). This subgroup analysis evaluated the efficacy and safety of erdafitinib in the Asian population in cohort 1 of the THOR study.

Methods

Patients in cohort 1 were randomised to erdafitinib (8 mg once daily) or chemotherapy (vinflunine or docetaxel once every 3 weeks). The primary endpoint was overall survival (OS).

Results

76 patients (erdafitinib: 37; docetaxel: 39; vinflunine: 0) from China, Japan, Korea and Taiwan were analysed. Overall, 68% had 2 prior lines of treatments and 51% had their primary tumour in the upper urinary tract. Median follow up was 15.7 months. Median OS (23.3 vs 11.3 months), median progression-free survival (PFS; 5.6 vs 2.7 months) and overall response rate (ORR; 49 vs 8%) improved with erdafitinib vs chemotherapy (Table). Grade 3/4 treatment-related adverse events (AEs) and discontinuations due to treatment-related AEs occurred in 41% and 3% of patients on erdafitinib and 58% and 12% of those on chemotherapy, respectively. Table: 208O

Efficacy results

CI: Confidence interval; NE: Not evaluable.Data cutoff date 15 January 2023

Conclusions

In the Asian subgroup, erdafitinib showed improved survival and response vs chemotherapy, with no new safety concerns, consistent with the overall THOR population.

Clinical trial identification

NCT03390504.

Editorial acknowledgement

Medical writing assistance was provided by Hui Hwa Choo, of Tech Observer Asia Pacific.

Legal entity responsible for the study

Janssen Research & Development.

Funding

Janssen Research & Development.

Disclosure

N. Matsubara: Financial Interests, Personal, Invited Speaker: Sanofi; Financial Interests, Institutional, Coordinating PI: Janssen, Roche, MSD, Taiho, Pfizer, Chugai; Financial Interests, Institutional, Local PI: AstraZeneca, Bayer, Astellas, Amgen, Eisai, Eli Lilly, AbbVie. Y. Loriot: Financial Interests, Personal, Advisory Board: Merck Kga, Pfizer, Gilead, Seattle genetics, Tahio; Financial Interests, Personal, Other, lectures, advisory boards: MSD, AstraZeneca, Astellas, Janssen; Financial Interests, Personal, Other, lectures, advisroy boards: Roche, BMS; Financial Interests, Institutional, Research Grant: Janssen, Sanofi, MSD, Roche, Celsius; Financial Interests, Institutional, Steering Committee Member: Janssen; Financial Interests, Personal, Steering Committee Member: msd, Astellas, Gilead/immunomedics, Basilea, Tahio; Financial Interests, Institutional, Local PI: Pfizer, MSD, Janssen, Exelexis, AstraZeneca, Pfizer, Merck Kga, BMS, Astellas, Gilead, Incyte; Financial Interests, Institutional, Coordinating PI: Janssen; Non-Financial Interests, Personal, Member: ESMO, ASCO, AACR; Non-Financial Interests, Personal, Other, scientific committee: ARC. E.F. Burgess: Financial Interests, Personal, Advisory Board: Exelixis; Financial Interests, Personal, Stocks/Shares: Exelixis, Gilead; Financial Interests, Institutional, Research Grant: Astellas. R.A. Huddart: Financial Interests, Personal, Advisory Board: Astellas, Bristol Myers Squibb, MSD; Financial Interests, Personal, Expert Testimony: National Institute of CLinical excellence; Financial Interests, Personal, Advisory Board, Advisory/trial steering committee: Nektar; Financial Interests, Personal, Invited Speaker: Pfizer; Financial Interests, Personal, Advisory Board, advisory/consultancy/lecture fees: Roche; Financial Interests, Personal, Other, Limited liability partnershi: Cancer centre London; Financial Interests, Institutional, Royalties: Janssen; Financial Interests, Institutional, Other, local investigator per patient funding: Astellas; Financial Interests, Institutional, Local PI, local PI per patient funding: Basilea, MSD, Roche; Financial Interests, Institutional, Coordinating PI, PI on CRUK funded studies: cancer Research UK; Financial Interests, Personal and Institutional, Local PI, per patient funding: Janssen; Financial Interests, Institutional, Research Grant, Trial grant funding: MSD; Financial Interests, Personal and Institutional, Steering Committee Member, local PI per patient funding: nektar; Financial Interests, Institutional, Research Grant, grant for protocol - Chief investigator: Roche. B. Tran: Financial Interests, Personal, Advisory Board: Amgen, AstraZeneca, Astellas, Bayer, BMS, Ipsen, IQVIA, Janssen, Merck, MSD, Novartis, Pfizer, Roche, Sanofi, Tolmar, Sanofi Ammunix; Financial Interests, Personal, Invited Speaker: Amgen, Astellas, AstraZeneca, Bayer, BMS, Merck, Pfizer; Financial Interests, Institutional, Research Grant: Amgen, Astellas, AstraZeneca, Bayer, BMS, Genentech, Ipsen, Janssen, Pfizer, MSD; Financial Interests, Personal, Steering Committee Member: CG Oncology, Janssen, MSD. S. Triantos: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks/Shares: Johnson & Johnson. K. Deprince: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson; Financial Interests, Personal, Stocks or ownership: Johnson & Johnson. S. Mukhopadhyay: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson. R. Hemaya: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson. J. Zhuo: Financial Interests, Personal, Full or part-time Employment: Johnson & Johnson. A.O. Siefker-Radtke: Financial Interests, Personal, Other, Consulting/advisory fees: AstraZeneca; Financial Interests, Personal, Other, Consulting/advisory honorarium: Bavarian Nordic, Bristol Myers Squibb, Genentech, Gilead, Ideeya Biosciences, Immunomedics, Janssen, Loxo, Merck, Mirati, Nektar Therapeutics, Seattle Genetics, Taiho; Financial Interests, Institutional, Local PI, Clinical research trial.: Basilea Pharmaceutica, Bristol Myers Squibb; Financial Interests, Institutional, Local PI, Clinical research trial: Janssen, Merck, Millennium, Nektar. All other authors have declared no conflicts of interest.