New advances in CPMCRI cancer research to be presented at the European Society for Medical Oncology Meeting

California Pacific CURRENTS: The online journal of CPMC Research Institute

October 3, 2016

Ari Baron, MD, Medical Director of the Clinical Oncology Research Program at CPMC, Chief of the Division of Hematology-Oncology and CPMCRI Scientist, will present new research at the European Society for Medical Oncology (ESMO) congress in Denmark this week. Themed “From disease treatment to patient care”, the EMSO meeting promises to reveal new approaches to treating cancer.  

Dr. Baron co-authored a phase 2, open-label, single-arm study assessing the efficacy of nivolumab in patients with metastatic urothelial cancer whose tumors progressed or recurred following treatment with a platinum-based drug. The primary study endpoint was objective response rate (ORR), which was evaluated in all patients treated, and correlated with tumor programmed death-1 (PD-1) expression.

Urothelial cancer typically occurs in the urinary system and affects the kidney, urinary bladder, or related organs. It is the most common type of bladder cancer. Most patients present with advanced disease and their response rates with traditional therapies, usually cisplatin (a type of chemotherapy), are approximately 50%. For patients unresponsive to cisplatin-based therapy, there is no approved second-line option.

Nivolumab is a breakthrough cancer immunotherapy that releases a natural immune system ‘brake’ known as PD-1, which some tumors use to evade an immune system attack. It was approved by the U.S. Food and Drug Administration (FDA) in 2014 for the treatment of melanoma and has since been approved for use in some solid tumors. Promising response rates were seen with nivolumab in advanced bladder cancer, in the phase 1/2 CheckMate 032 study.

At seven months’ median follow-up in the larger CheckMate 275 study, the ORR was 19.6% and 16.1% in patients with low-to-no PD-1 expression, respectively. The median progression-free survival was 2.0 months and the median overall survival was 8.74 months. Grade 3-4 treatment-related adverse events occurred in 18% of patients, mainly fatigue and diarrhea.

“Patients with advanced stages of urothelial cancer have high rates of disease recurrence and progression. New research is critical to address this unmet medical need. The CheckMate 275 study suggests that, in patients with advanced, unresectable urothelial cancer, nivolumab improves outcomes and has a relatively low risk of serious adverse events,” says Dr. Baron.

“The drug showed benefit in all PD-1 subgroups, which means that PD-1 expression does not yet adequately differentiate patients potentially responsive to therapy. This study should lead to the FDA approval of nivolumab in metastatic bladder cancer after platinum chemotherapy failure.”

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