Journal article
Phase Ib study of concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with urothelial cancer of the bladder: BTCRC-GU15-023 study
Journal of clinical oncology, Vol.36(6_suppl), pp.455-455
02/20/2018
DOI: 10.1200/JCO.2018.36.6_suppl.455
Abstract
Abstract only
455
Background: There is a significant variation in the treatment of locally advanced unresectable (T2-4 N0-2 M0) or cisplatin-ineligible (non-cis) bladder cancer (BC) patients (pts). The advent of immunotherapy (IO) in non-cis stage IV BC has been promising (response rate [RR] 23%; median survival 16 mo) but we are still in need of novel combinations for locally advanced unresectable BC. Durvalumab (Durva) is a human monoclonal antibody that inhibits the binding of PD-L1 to PD-1 on T-cell receptors. It has shown efficacy in platinum refractory BC with RR of 17%. Radiation (RT) is also effective in BC and can upregulate pro-inflammatory signals allowing for improved antitumor activity of IO. We report the safety data from phase Ib trial of combining RT with Durva (DurvaRT) in locally advanced BC. Methods: Treatment (Rx) naïve or post neoadjuvant chemotherapy pts with T3-4, N0-2, M0 who were either unresectable or unfit for surgery were treated with DurvaRT followed by Durva. Rx naïve locally advanced non-cis pts were also included in the study. DurvaRT: Durva 1500mg D1, D28 plus concurrent RT, 64.8Gy given in 36 fractions over 7weeks starting D1. These patients then started adjuvant Q4 weekly Durva after 4 weeks for 12 months. Primary end point for Ph Ib was safety of combining Durva with RT during 7-weeks period. Results: We enrolled 6 pts on phase Ib. 5/6 pts had completed the DurvaRT phase and none of them had any dose limiting toxicity. The table below summarizes the treatment related adverse events (TRAE). Post DurvaRT 3/4 pts have ongoing ORR; 1 pt. had progression; Rx response evaluation in 2 pts is ongoing. Clinical trial information: NCT02891161. Conclusions: DurvaRT was tolerable in pts with locally advanced unresectable BC, where there is a dearth for good Rx options. No grade 3 immune related AEs were observed during DurvaRT. Further investigation with DurvaRT is ongoing to evaluate the efficacy in this subset of pts (Clinical trial # NCT02891161).[Table: see text]
Details
- Title: Subtitle
- Phase Ib study of concurrent durvalumab and radiation therapy (DUART) followed by adjuvant durvalumab in patients with urothelial cancer of the bladder: BTCRC-GU15-023 study
- Creators
- Monika Joshi - Penn State Milton S. Hershey Medical CenterLeonard Tuanquin - Penn State Milton S. Hershey Medical CenterMatthew Kaag - Penn State Milton S. Hershey Medical CenterYousef Zakharia - University of IowaJason Liao - Penn State Milton S. Hershey Medical CenterSuzanne Merrill - Penn State Milton S. Hershey Medical CenterDana Musapatika - Big Ten Cancer Research Consortium, Indianapolis, INDavid DeGraff - Pennsylvania State UniversityHong Zheng - Penn State Milton S. Hershey Medical CenterJoshua Warrick - Penn State Milton S. Hershey Medical CenterSheldon L. Holder - Penn State Milton S. Hershey Medical CenterMark Stein - Rutgers, The State University of New JerseyJoseph J. Drabick - Penn State Milton S. Hershey Medical Center
- Resource Type
- Journal article
- Publication Details
- Journal of clinical oncology, Vol.36(6_suppl), pp.455-455
- DOI
- 10.1200/JCO.2018.36.6_suppl.455
- ISSN
- 0732-183X
- eISSN
- 1527-7755
- Language
- English
- Date published
- 02/20/2018
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984548380402771
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