ECCO 2015 Studies Confirm Roles for Nivolumab in Kidney Cancer, Nanoliposomal Irinotecan in Pancreatic Cancer
BUFFALO, N.Y. — In separate studies presented at the just-concluded European Cancer Congress (ECCO 2015), which was held in conjunction with the annual meeting of the European Society for Medical Oncology (ESMO 2015), researchers from Roswell Park Comprehensive Cancer Center reported promising findings about a pair of breakthrough drugs in cancers that have in the past proven to be notoriously difficult to treat.
Saby George, MD, FACP, was co-author on the landmark CheckMate 025 phase III study (abstract 3LBA) comparing the effectiveness of the anti-PD-1 targeted immunotherapy drug nivolumab (brand name Opdivo) with standard chemotherapy (everolimus, brand name Afinitor) in advanced kidney cancer, and presenting author on a related study of nivolumab in patients treated beyond the progression of their disease.
The findings from the phase III study, which was stopped early because evidence showed a clear benefit of treatment with nivolumab, were published simultaneously in the New England Journal of Medicine (Robert Motzer et al., “Nivolumab versus everolimus in advanced renal cell carcinoma”). The U.S. Food and Drug Administration (FDA) recently granted Breakthrough Therapy status to nivolumab based on these striking findings, which mark the first time an agent has demonstrated, as a primary endpoint, an overall survival benefit compared to standard of care in second-line metastatic renal cell carcinoma.
“The CheckMate 025 study, which included Roswell Park as a participating site, has demonstrated the clear superiority of nivolumab to earlier therapies, setting a new standard as second-line therapy for treatment of patients with metastatic renal cell carcinoma,” notes Dr. George, an Assistant Professor of Oncology in the Department of Medicine at Roswell Park. “This study re-establishes the importance of immunotherapy in kidney cancer and confirms that checkpoint inhibitors — a new generation of immunotherapies and a totally new class of drug — are easy to administer in the outpatient setting.”
Immunotherapy was the dominant theme throughout the meeting. Dr. George’s podium presentation on the companion phase II study (CheckMate 010) in patients with progressive disease (abstract 501), part of a Proffered Paper Session in immunotherapy, highlighted new evidence regarding assessment of response in patients receiving immunotherapies such as nivolumab, reporting that patients whose kidney cancer resists standard treatment can safely continue nivolumab, thus extending survival.
Another Roswell Park faculty member, Wen Wee Ma, MBBS, presented new findings (abstract 2365) on MM-398, a nanoliposomal irinotecan (also known as nal-IRI), in collaboration with NAPOLI-1 investigators and Merrimack Pharmaceuticals, led by Dr. Bambang Adiwijaya as the clinical pharmacologist.
"We analyzed the clinical effects of MM-398 in 353 cancer patients with metastatic cancer, including those who took part in the pivotal randomized trial NAPOLI-1,” says Dr. Ma, an Associate Professor of Oncology in the Department of Medicine at Roswell Park. “Our modeling suggests that this new liposomal formulation improves the pharmacokinetic profile of irinotecan considerably and, when given in combination with 5-fluourorcil and leucovorin, results in significant anticancer effects in patients with metastatic pancreatic cancer previously treated with gemcitabine-based therapy. We noted a significant relationship between MM-398 pharmacokinetics and baseline factors including race, bilirubin and body size — which suggests that careful patient stratification may be important in any follow-on studies.”
Dr. Ma also presented the results of a phase Ib study of dovitinib plus standard chemotherapy (gemcitabine and capecitabine) in patients with advanced pancreatic cancer, (abstract 2315), concluding that this combination merits further study.
The mission of Roswell Park Comprehensive Cancer Center is to understand, prevent and cure cancer. Founded in 1898, Roswell Park is one of the first cancer centers in the country to be named a National Cancer Institute-designated comprehensive cancer center and remains the only facility with this designation in Upstate New York. The Institute is a member of the prestigious National Comprehensive Cancer Network, an alliance of the nation’s leading cancer centers; maintains affiliate sites; and is a partner in national and international collaborative programs. For more information, visit www.roswellpark.org, call 1-800-ROSWELL (1-800-767-9355) or email AskRoswell@Roswellpark.org. Follow Roswell Park on Facebook and Twitter.
Annie Deck-Miller, Senior Media Relations Manager