ERDAFITINIB in locally advanced or metastatic urothelial carcinoma (mUC): Long-term outcomes in BLC2001.

Author:

Siefker-Radtke Arlene O.1,Necchi Andrea2,Park Se Hoon3,García-Donas Jesús4,Huddart Robert A5,Burgess Earle Frederick6,Fleming Mark T.7,Rezazadeh Arash8,Mellado Begona9,Varlamov Sergei10,Joshi Monika11,Duran Ignacio12,Tagawa Scott T.13,Zakharia Yousef14,Fu Min15,Santiago-Walker Ademi E.16,Monga Manish17,OHagan Anne18,Mosher Silvia19,Loriot Yohann20,

Affiliation:

1. The University of Texas MD Anderson Cancer Center, Houston, TX;

2. Fondazione IRCCS Istituto Nazionale dei Tumori, Milan, Italy;

3. Samsung Medical Center, Department of Medicine, Seoul, South Korea;

4. Fundacion Hospital de Madrid, Madrid, Spain;

5. Royal Marsden NHS Foundation Trust, Sutton, United Kingdom;

6. Levine Cancer Institute, Charlotte, NC;

7. Virginia Oncology Associates, US Oncology Research, Norfolk, VA;

8. Norton Healthcare, Louisville, KY;

9. Hospital Clínic of Barcelona, Institut d'Investigacions Biomèdiques August Pi i Sunyer, Barcelona, Spain;

10. Altai Regional Cancer Center, Barnaul, Russian Federation;

11. Penn State Health Milton S. Hershey Medical Center, Hershey, PA;

12. Department of Medical Oncology, Hospital Universitario Marqués de Valdecilla, Santander, Spain;

13. Weill Cornell Medical College, New York, NY;

14. University of Iowa and Holden Comprehensive Cancer Center, Iowa City, IA;

15. Janssen Research and Development, Springhouse, PA;

16. Janssen Research & Development, Spring House, PA;

17. Clinical Oncology, Janssen R&D US, Springhouse, PA;

18. Janssen Research & Development, LLC, Spring House, PA;

19. Janssen Research and Development, San Diego, CA;

20. Institut de Cancérologie Gustave Roussy, Villejuif, France;

Abstract

5015 Background: Erdafitinib (JNJ-42756493; ERDA) is the only pan-FGFR kinase inhibitor with US FDA approval for treatment of adults with mUC with susceptible FGFR3/2 alterations (alt) and who progressed on ≥ 1 line of prior platinum-based chemotherapy (chemo). Approval was based on data from the primary analysis of the pivotal BLC2001 trial1. Here we report long-term efficacy and safety data from the 8 mg/d continuous dose regimen in BLC2001. Methods: BLC2001 (NCT02365597) is a global, open-label, phase 2 trial of pts with measurable mUC with prespecified FGFR alt, ECOG 0-2, and progression during/following ≥ 1 line of prior chemo or ≤ 12 mos of (neo)adjuvant chemo, or were cisplatin ineligible, chemo naïve. The optimal schedule of ERDA determined in the initial part of the study was 8 mg/d continuous ERDA in 28-d cycles with uptitration to 9 mg/d (ERD 8 mg UpT) if a protocol-defined target serum phosphate level was not reached and if no significant treatment-related adverse events (TRAEs) occurred. Primary end point was the confirmed objective response rate (ORR=% complete response + % partial response). Key secondary end points were progression-free survival (PFS), duration of response (DOR) and overall survival (OS). Results: Median follow-up for 101 patients treated with ERDA 8 mg UpT was ~24 months. Confirmed ORR was 40%. Median DOR was 5.98 mos; 31% of responders had DOR ≥ 1 yr. Median PFS was 5.52 mos, median OS was 11.3 mos. 12-mos and 24-mos survival rates were 49% and 31%, respectively. Median treatment duration was 5.4 mos. The ERDA safety profile was consistent with the primary analysis. No new TRAEs were seen with longer follow-up. Central serous retinopathy (CSR) events occurred in 27% (27/101) of patients; 85% (23/27) were Grade 1 or 2; dosage was reduced in 13 pts, interrupted for 8, and discontinued for 3. On the data cut-off date, 63% (17/27) had resolved; 60% (6/10) of ongoing CSR events were Grade 1. There were no treatment-related deaths. Conclusions: With a median follow-up of 2 yrs, ERDA in mUC + FGFR alt showed a manageable safety profile and consistent efficacy, with median OS of 11.3 mos. 31% had a DOR ≥12 mos and 31% were alive at 24 mos. ERDA monotherapy vs. immune checkpoint inhibitor (PD-1) or chemo is being further analyzed in a randomized control study (THOR; NCT03390504).Reference: Loriot Y, et al. N Engl J Med. 2019;381:338-48. Clinical trial information: NCT02365597 .

Funder

Janssen Research and Development

Publisher

American Society of Clinical Oncology (ASCO)

Subject

Cancer Research,Oncology

Cited by 18 articles. 订阅此论文施引文献 订阅此论文施引文献,注册后可以免费订阅5篇论文的施引文献,订阅后可以查看论文全部施引文献

同舟云学术

1.学者识别学者识别

2.学术分析学术分析

3.人才评估人才评估

"同舟云学术"是以全球学者为主线,采集、加工和组织学术论文而形成的新型学术文献查询和分析系统,可以对全球学者进行文献检索和人才价值评估。用户可以通过关注某些学科领域的顶尖人物而持续追踪该领域的学科进展和研究前沿。经过近期的数据扩容,当前同舟云学术共收录了国内外主流学术期刊6万余种,收集的期刊论文及会议论文总量共计约1.5亿篇,并以每天添加12000余篇中外论文的速度递增。我们也可以为用户提供个性化、定制化的学者数据。欢迎来电咨询!咨询电话:010-8811{复制后删除}0370

www.globalauthorid.com

TOP

Copyright © 2019-2024 北京同舟云网络信息技术有限公司
京公网安备11010802033243号  京ICP备18003416号-3