Perioperative pembrolizumab therapy in muscle-invasive bladder cancer: Phase III KEYNOTE-866 and KEYNOTE-905/EV-303.
Matthew D. Galsky,Christopher J. Hoimes,Andrea Necchi,Neal D. Shore,J. Alfred Witjes,Gary D. Steinberg,Jens Bedke,Hiroyuki Nishiyama,Xiao Fang,Ritesh S. Kataria,Eric Sbar,Xieyang Jia,Arlene O. Siefker-Radtke +12 more
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TLDR
The randomized Phase III KEYNOTE-866 and KeyNOTE-905/EV-303 studies are being conducted to evaluate efficacy and safety of perioperative pembrolizumab or placebo with chemotherapy in cisplatin-ineligible patients with MIBC as discussed by the authors.Abstract:
Muscle-invasive bladder cancer (MIBC) is associated with high rates of recurrence and poor prognosis despite aggressive treatment. Neoadjuvant chemotherapy before radical cystectomy (RC) improves outcomes in cisplatin-eligible patients; however, the improvement in overall survival is modest. Standard of care for cisplatin-ineligible patients remains RC; more effective systemic therapies are needed. Recent Phase Ib/II studies suggest pembrolizumab monotherapy and combination therapy are effective neoadjuvant therapies for MIBC. The randomized Phase III KEYNOTE-866 and KEYNOTE-905/EV-303 studies are being conducted to evaluate efficacy and safety of perioperative pembrolizumab or placebo with chemotherapy in cisplatin-eligible patients with MIBC (KEYNOTE-866) and of pembrolizumab monotherapy versus pembrolizumab plus enfortumab vedotin versus RC plus pelvic lymph node dissection alone in cisplatin-ineligible patients with MIBC (KEYNOTE-905/EV-303). Clinical trial registration: NCT03924856 & NCT03924895 (ClinicalTrials.gov).read more
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Research Trends and Most Influential Clinical Studies on Anti-PD1/PDL1 Immunotherapy for Cancers: A Bibliometric Analysis
Yanhao Liu,Yan Xu,Xi Cheng,Yaru Lin,Shu Jiang,Haiming Yu,Zhen Zhang,Linlin Lu,Xiao-Tao Zhang +8 more
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Urinary Tract Tumor Organoids Reveal Eminent Differences in Drug Sensitivities When Compared to 2-Dimensional Culture Systems
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Expressions of PD-L1 and Nectin-4 in urothelial cancer patients treated with pembrolizumab.
H. Ueki,Nobuyuki Hinata,Koichi Kitagawa,Takuto Hara,Tomoaki Terakawa,Junya Furukawa,Ken-ichi Harada,Y. Nakano,M. Komatsu,Masato Fujisawa,Toshiro Shirakawa +10 more
TL;DR: In this article, the association between immunohistochemical biomarkers and clinical outcomes in urothelial cancer patients treated with pembrolizumab was explored and the associations between protein expressions and overall survival (OS), progression-free survival (PFS), and disease control rate (DCR) were statistically analyzed.
References
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Phase Ib/II neoadjuvant (N-) pembrolizumab (P) and chemotherapy for locally advanced urothelial cancer (laUC): Final results from the cisplatin (C)- eligible cohort of HCRN GU14-188.
Christopher J. Hoimes,Nabil Adra,Mark D. Fleming,Hristos Z. Kaimakliotis,Joel Picus,Zachary L. Smith,Radhika Walling,Edouard J. Trabulsi,Jean H. Hoffman-Censits,Michael O. Koch,Clint Cary,Robert Abouassaly,Cheryl Eitman,Pingfu Fu,Gordon Goolamier,Adam Calaway,L. Ponsky,William Kevin Kelly +17 more
TL;DR: Patients with laUC who are C-eligible for N- therapy may benefit from combination chemo-immunotherapy and Cohort 1 of the GU14-188 trial is a phase 1b/2 trial designed to as well.
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Phase II neoadjuvant (N-) gemcitabine (G) and pembrolizumab (P) for locally advanced urothelial cancer (laUC): Interim results from the cisplatin (C)-ineligible cohort of GU14-188.
Hristos Z. Kaimakliotis,Nabil Adra,William Kevin Kelly,Edouard J. Trabulsi,Richard C. Lauer,Joel Picus,Zachary L. Smith,Radhika Walling,Timothy A. Masterson,Adam Calaway,Michael O. Koch,Elizabeth Sonderman,Pingfu Fu,Gordon Goolamier,Cheryl Eitman,L. Ponsky,Christopher J. Hoimes +16 more
TL;DR: Patients with laUC who are C-ineligible have inferior survival compared to counterparts who receive C based N-therapy and have a pathologic response at radical cystectomy (RC)...
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Pembrolizumab (pembro) for the treatment of patients with Bacillus Calmette-Guérin (BCG) unresponsive, high-risk (HR) non–muscle-invasive bladder cancer (NMIBC): Over two years follow-up of KEYNOTE-057.
Arjun Vasant Balar,Ashish M. Kamat,Girish S. Kulkarni,Edward Uchio,Joost L. Boormans,Dean F. Bajorin,Mathieu Roumiguié,Eric A. Singer,Laurence Eliot Miles Krieger,Petros Grivas,Ho Kyung Seo,Hiroyuki Nishiyama,Badrinath R. Konety,Kijoeng Nam,João Paulo Zambon,Ekta Kapadia,Ronald de Wit +16 more
TL;DR: Pembro was recently approved for the treatment of HR NMIBC based on results from the phase 2 KEYNOTE-057 study and herein the present safety, efficacy, and posttreatment results.
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Neoadjuvant vs. Adjuvant Chemotherapy in Muscle Invasive Bladder Cancer (MIBC): Analysis From the RISC Database
Gabriella Del Bene,Fabio Calabrò,Diana Giannarelli,Elizabeth R. Plimack,Lauren C. Harshman,Evan Y. Yu,Simon J. Crabb,Sumanta K. Pal,Ajjai Alva,Thomas Powles,Ugo De Giorgi,Neeraj Agarwal,Aristotelis Bamias,Sylvain Ladoire,Andrea Necchi,Ulka N. Vaishampayan,Günter Niegisch,Joaquim Bellmunt,Jack Baniel,Matthew D. Galsky,Cora N. Sternberg +20 more
TL;DR: This study demonstrates superiority in DFS for NC compared to AC and the positive prognostic impact of complete pathological response to NC was confirmed, demonstrating superiority in overall survival and disease-free survival.
Journal ArticleDOI
Trends and disparities in the use of neoadjuvant chemotherapy for muscle-invasive urothelial carcinoma
Jonathan J. Duplisea,Ross J. Mason,Chad A. Reichard,Roger Li,Yu Shen,Stephen A. Boorjian,Colin P.N. Dinney +6 more
TL;DR: Use of NAC has increased significantly over time to a modest rate of 32%.