LONG-TERM SURVIVAL Findings of Long-Term Overall Survival With Nivolumab BY ROBIN HOCEVAR C Study Characteristics The phase I and II studies were broken into two treatment arms and both sets of patients required failing prior treatments. The phase I population was more heavily pre-treated. Dosing and scheduling were different in the two arms, but McDermott assured au-diences this didn’t alter clinical outcomes. Unacceptable toxicity was cause to discon-tinue treatment, as was conﬁ rmed tumor progression. According to McDermott, for patients who achieved clinical beneﬁ t, treat-ment was limited to 96 weeks on phase I and given continuously until progression on phase II. In the phase I study, the primary end-point was safety and tolerability. A key sec-ondary endpoint was objective response rate. In the phase II study, the primary end-point was dose response by progression-free oncology-times.com survival and the key secondary endpoints were response rate, overall survival, and toxicities. Understanding Long-Term Overall Survival All told on both trials, median long-term overall survival data was greater than 22 months. “With follow-up over 48 months, ap-proximately one-third of patients are still alive at 4 years in both studies,” shared McDermott. “At 5 years, 34 percent were alive on the phase I trial. We look forward to seeing whether nivolumab produces similar long-term survival in the phase III study.” Separating patients by baseline and response characteristics shed more light on the nivolumab versus everolimus de-bate. In phase II, the team used Sloan Kettering criteria to classify patients by outcomes of good, intermediate, and poor risk. “In the phase II clinical trial, encour-aging long-term survival was seen in both favorable and unfavorable sub-groups,” he noted. “Long-term survival was seen in patients with excellent or reduced per-formance status. In patients with objec-tive response, stable disease or progressive disease as their best response, these data Continued on page 14 Oncology Times 13 National Cancer Institute HICAGO—At the 2016 ASCO Annual Meeting, David McDermott, MD, Director of the Biologic Therapy Program and Co-Director of the Kidney Tumor Program at Beth Israel Deaconess Medical Center, Boston, presented results of a study he co-authored on long-term overall survival with nivolumab in pa-tients previously treated for advanced re-nal cell carcinomas. In the phase III Checkmate 025 study, patients who’d received prior anti-angio-genic therapy then nivolumab experi-enced a longer overall survival than those in an everolimus treatment regimen. McDermott and his team questioned if nivolumab’s beneﬁ ts are maintained in the long-term. Hence, the clinicians set out on what turned out to be the longest follow-up with an anti-PD-1 agent to date in renal cell carcinoma. The phase I and II studies on survival and safety results spanned 4 years and ultimately reinforced the advantages of nivolumab.