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PD-1/CTLA-4 Inhibitor Combination Highly Effective for Metastatic Bladder Cancer
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Early results from a pre-planned interim analysis in the KEYNOTE-052 phase II trial of first-line pembrolizumab in cisplatin-ineligible patients with metastatic urothelial cancer demonstrated antitumor activity.

First-line pembrolizumab demonstrated significant antitumor activity in cisplatin-ineligible patients with metastatic urothelial cancer.

Arjun Balar, MD, assistant professor of medicine, Division of Hematology & Oncology, New York University Cancer Institute, NYU Langone Medical Center, discusses the results of a recent first-line study of pembrolizumab in advanced urothelial cancer.

Findings of the phase III KEYNOTE-045 trial showed pembrolizumab (Keytruda) demonstrated improved survival compared with chemotherapy in previously treated patients with advanced urothelial cancer.

Nivolumab (Opdivo) has received a priority review designation from the FDA as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma.

Matthew Galsky, MD, professor of Medicine, Mount Sinai School of Medicine, discusses the significant findings in, and the rationale behind conducting the CheckMate-275 trial during an interview at the 2016 ESMO Congress.

Safety, efficacy, and biomarker results from the phase II CheckMate-275 trial of the PD-1 inhibitor nivolumab (Opdivo) that support FDA and European Medicines Agency (EMA) applications were reported at the 2016 ESMO Congress.

Jim Zhong, MD, and colleagues describe a National Cancer Database (NCDB) outcomes analysis of patients with muscle invasive bladder cancer treated with either radical surgery or bladder preservation therapy.

Gary D. Steinberg, MD, discusses how medical oncologists can benefit from the new American Urological Association guidelines when treating bladder cancer.

In a 14-0 vote, the FDA’s Oncologic Drugs Advisory Committee (ODAC) denied the approval of apaziquone (EOquin; Qapzola) for intravesical instillation immediately following transurethral resection in patients with non-muscle invasive bladder cancer.

A type II variation application for the use of nivolumab (Opdivo) as a treatment for patients with locally advanced unresectable or metastatic urothelial carcinoma (mUC) who have progressed following platinum-based chemotherapy is now under formal review.

Though the current standard of care when treating muscle-invasive bladder cancer calls for neoadjuvant chemotherapy followed by radical cystectomy, the procedure is associated with a fair amount of morbidity and is not suggested lightly, according to Stanley Yap, MD.

Cell cycle progression (CCP) and homologous recombination deficiency (HRD) may be linked to bladder cancer recurrences and pathologic complete responses, according to Hristos Kaimakliotis, MD.

Alexander I. Sankin, MD, assistant professor of Urology at Montefiore Medical Center at the Albert Einstein College of Medicine, discusses the differences between the recently defined checkpoint HHLA2 and PD-L1 expression in urothelial tumors, as well as next steps in this space.

The field of metastatic bladder cancer—an area that had long been stagnant—has quickly evolved with the recent FDA approval of atezolizumab (Tecentriq) coupled with the breakthrough therapy designation of nivolumab (Opdivo).

Across the fields of renal cell carcinoma, bladder cancer, and prostate cancer, immunotherapy agents are moving through the pipeline and impacting patient outcomes—some quicker than others.

The treatment paradigm of metastatic urothelial carcinoma was shaken up in May 2016 when the FDA approved the PD-L1 inhibitor atezolizumab for the treatment of patients with locally advanced or metastatic disease.

Atezolizumab proves to be non-toxic and shows major survival advantage in patients with metastatic urothelial bladder cancer.

Stanley Yap, MD, assistant professor, urologic oncology, UC Davis Comprehensive Cancer Center, discusses needed improvements and next steps in neoadjuvant chemotherapy for muscle-invasive bladder cancer.

The FDA has granted nivolumab a breakthrough therapy designation for the treatment of patients with resectable locally advanced or metastatic urothelial carcinoma after the failure of a platinum-containing regimen.

The PD-L1 inhibitor durvalumab demonstrated an objective response rate of 46% for patients with high PD-L1-expressing advanced urothelial bladder cancer.

The recent FDA approval of atezolizumab was a significant milestone for the second-line treatment of locally advanced bladder cancer, with even greater potential still on the horizon for the PD-L1 agent.

Jonathan E. Rosenberg, MD, medical oncologist, Memorial Sloan Kettering Cancer, discusses what is on the horizon for the treatment landscape of bladder cancer.

Infusion with 19-28z chimeric antigen receptor (CAR) modified T-cells led to complete response (CR) rates of 77% to 90% and minimal residual disease (MRD)-CR rates of 68% to 70% in adult patients with relapsed or refractory B-cell acute lymphocytic leukemia (B-ALL).

Neratinib, an experimental TKI being developed for breast cancer, achieved a 36% clinical benefit rate in a phase II trial, according to a poster presented June 5, 2016 at the ASCO Annual Meeting in Chicago.






















































