Efficacy and safety of nivolumab monotherapy in metastatic urothelial cancer (mUC): Results from the phase I/II CheckMate 032 study.

Sharma, Padmanee; Bono, Petri; Kim, Joseph W.; Spiliopoulou, Pavlina; Calvo, Emiliano; Pillai, Rathi N.; Ott, Patrick A.; Braud, Filippo G. De; Morse, Michael A.; Le, Dung T.; Jaeger, Dirk; Chan, Emily; Harbison, Christopher; Lin, Chensheng; Tschaika, Marina; Azrilevich, Alex; Rosenberg, Jacob

doi:10.1200/jco.2016.34.15_suppl.4501

Cited by 57 publications

(47 citation statements)

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“…97 Of the 78 patients enrolled in this study, 2 experienced grade 5 treatment-related AEs, and grade 3 or 4 treatment-related AEs were reported in 22% of patients. 97 Early results from a phase I/II multicenter study of durvalumab for 61 patients with PD-L1-positive inoperable or metastatic urothelial bladder cancer whose tumor had progressed during or after one standard platinum-based regimen showed that 46.4% of patients who were PD-L1-positive had disease that responded to treatment; no response was seen in patients who were PD-L1-negative. 98 A 2017 update on this study (N=103) showed a 29.5% ORR for PD-L1-high disease and a 7.7% ORR for PD-L1-low/negative disease.…”

Section: Targeted Therapiesmentioning

confidence: 83%

Bladder Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

Spiess¹,

Agarwal²,

Bangs³

et al. 2017

J Natl Compr Canc Netw

228

173

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OverviewAn estimated 79,030 new cases of urinary bladder cancer (60,490 men and 18,540 women) will be diagnosed in the United States in 2017 and approximately 16,870 deaths (12,240 men and 4630 women) will occur. Please NoteThe NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines Disclosures for the NCCN Bladder Cancer PanelAt the beginning of each NCCN Guidelines panel meeting, panel members review all potential conflicts of interest. NCCN, in keeping with its commitment to public transparency, publishes these disclosures for panel members, staff, and NCCN itself.Individual disclosures for the NCCN Bladder Cancer Panel members can be found on page 1267 (The most recent version of these guidelines and accompanying disclosures are available on the NCCN Web site at NCCN.org.)These guidelines are also available on the Internet. For the latest update, visit NCCN.org.

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Section: Targeted Therapiesmentioning

confidence: 83%

Bladder Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

Spiess¹,

Agarwal²,

Bangs³

et al. 2017

J Natl Compr Canc Netw

228

173

View full text Add to dashboard Cite

show abstract

“…The confirmed ORR was 26.0% in the patients whose specimens had PD-L1 expression of greater than or equal to 5% and 9.5% in the patients whose specimens had PD-L1 expression of less than 5%. Recently, another two PD-L1 inhibitors nivolumab [16] and pembrolizumab [17] also demonstrated promising activity for advanced urothelial carcinoma. Most studies investigating blockade of PD-1 or PD-L1 report favorable toxicity profiles with the vast majority of treatment related AE being of low grade [14,15,18,19].…”

Section: Discussionmentioning

confidence: 99%

Tumor Lysis Syndrome Following a Single Atezolizumab Infusion for Metastatic Urothelial Carcinoma Involving Both Upper and Lower Tract

Brunnhoelzl¹,

Weed²,

Trepet³

et al. 2017

Arch Can Res

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“…The ORR in the 44 patients reported on this trial was 18.2%, and was also higher in the group with higher PD-L1 expression (50.0 vs 4.3%), although using a cut-off of ≥5% on tumor cells only. Finally, nivolumab reported its first data from previously treated mUC patients who participated in the Phase I/II CheckMate-032 study [68]. the results were genrally comparable to other agents, with an ORR of 24.4%.…”

Section: • Immunotherapymentioning

confidence: 89%

Systemic Therapy for Bladder Cancer Finally Comes into a New Age

Zibelman

Plimack

2016

Future Oncol.

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Systemic therapy for bladder cancer, both localized muscle-invasive disease and metastatic disease, has seen minimal progress over the past two decades. Current approaches rely upon cytotoxic chemotherapy combinations aimed at increasing cure rates or achieving palliation and disease control, but these regimens are fraught with short-and long-term toxicities and outcomes remain suboptimal. The emergence of systemic immunotherapies that can provide durable remissions in subsets of patients with other malignancies has the potential to transform the field, and early phase trials have begun to demonstrate activity in some patients with metastatic bladder cancer. In this article, we review the current state of systemic therapy for bladder cancer and discuss the current literature and ongoing trials utilizing various immunotherapies. KEYWORDS• bladder cancerCancers of the urinary bladder are the sixth most commonly diagnosed malignancy in the USA and the most prevalent malignancy of the GI tract, with 74,000 new cases estimated from 2015 [1]. The predominant histologic subtype is urothelial carcinoma (UC), which accounts for more than 90% of diagnoses in the western world. For patients with muscle-invasive bladder cancer (MIBC) confined to the bladder and deemed surgical candidates, radical cystectomy (RC) with pelvic lymphadenectomy remains the gold standard, with bladder preservation techniques using combinations of radiation therapy (RT) and systemic therapy receiving increased attention [2][3][4][5]. Local therapy with surgery or radiation alone is suboptimal, with median overall survival (OS) ranging from 1.8 to 3.8 years and 5-year survival of only 43% after RC and less than 40% with RT, with the majority of deaths related to distant disease [6,7]. The addition of neoadjuvant chemotherapy (NAC) has significantly improved outcomes. For patients who present with metastatic disease, systemic chemotherapy with cisplatin-based regimens, long recognized as an active drug in this disease, is accepted as the standard of care. Thus, systemic therapy is an integral component of treatment for patients with UC, yet despite tremendous advances across a multitude of malignant conditions, no new therapies have entered the armamentarium in over decade. Fortunately, recent and ongoing research in the burgeoning field of cancer immunotherapy (IT) offers hope that new agents will finally demonstrate survival benefits in clinical trials. In this article, we review the definitive studies that have established the current standards of care for systemic treatment in UC, then focus on new and future trials aiming to bring the systemic treatment of UC into the IT age.For reprint orders, please contact: reprints@futuremedicine.com

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Efficacy and safety of nivolumab monotherapy in metastatic urothelial cancer (mUC): Results from the phase I/II CheckMate 032 study.

Cited by 57 publications

References 0 publications

Bladder Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

Bladder Cancer, Version 5.2017, NCCN Clinical Practice Guidelines in Oncology

Tumor Lysis Syndrome Following a Single Atezolizumab Infusion for Metastatic Urothelial Carcinoma Involving Both Upper and Lower Tract

Systemic Therapy for Bladder Cancer Finally Comes into a New Age

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