Bristol-Myers Squibb Company today announced results from a Phase 2 and a Phase 1b study of its investigational PD-1 immune checkpoint inhibitor nivolumab in patients with advanced or metastatic renal cell carcinoma (RCC), commonly known as kidney cancer. In the Phase 2 CheckMate -010 trial> who received prior anti-angiogenic treatment. In the Phase 1b CheckMate -016 trial, which evaluated the safety and tolerability of nivolumab at different doses and schedules as part of a regimen with other agents, ORR for the investigational combination regimen of nivolumab and ipilimumab.
"There continues to be a significant unmet medical need in patients with renal cell carcinoma across all lines of therapy," said Michael Giordano, Senior Vice President, Head of Development, Oncology & Immunosciences. "Results from the Phase 2 CheckMate -010 trial together with the first reported data combining two immune checkpoint inhibitors in RCC from CheckMate -016 offer important new insights into the potential of nivolumab as a single agent and as part of a combination regimen with ipilimumab in the treatment of patients diagnosed with this disease."
Results from Phase 2 Single-Agent Study in Previously-Treated Patients (CheckMate -010)
CheckMate -010 is a Phase 2 dose ranging study>1
Results, including those shown below, will be presented as an oral session at ASCO on May 31 at 3 p.m. CDT (Abstract #5009). No dose relationship for PFS was seen in this study. These results support the ongoing evaluation of nivolumab as a single agent in the Phase 3 study of patients diagnosed with RCC who have been previously treated (CheckMate -025).
Key Nivolumab Monotherapy Efficacy and Safety Results in Previously Treated RCC Patients
Related severe adverse events (AEs) occurred in 12/168 (7.2%) of patients across all doses. For 0.3, 2.0 and 10 mg/kg, 1 (2%), 6 (11%) and 4 (7%) patients, respectively, had treatment-related AEs that led to discontinuation. There was no grade 3-4 pneumonitis.
"Results from the Phase 2 CheckMate -010 trial support findings from the Phase 1b Study -003 and provide additional data on the antitumour activity of nivolumab in patients with renal cell carcinoma," said Robert Motzer, MD, Memorial Sloan Kettering Cancer Center, New York, NY. "These data are encouraging as we seek to identify new treatments for patients, particularly those who progress following treatment with anti-angiogenic therapy, as these patients have limited options."
Results from Phase 1b Study of Combination Regimen in Previously Treated and Treatment-Naïve Patients (CheckMate -016)
CheckMate -016 is a multi-arm Phase 1b trial evaluating the safety and tolerability of nivolumab at different doses and schedules as part of a regimen with other agents, including as part of a combination regimen with ipilimumab, in both previously treated and treatment-naïve patients with RCC. In the arm evaluating the combination regimen of nivolumab and ipilimumab
Data from this cohort, including those shown below, will be featured as an oral presentation at ASCO on June 2 at 9:45 a.m. CDT (Abstract #4504). Related SAEs occurred in 8/44 (18%) for all regimens. The most common SAEs were elevated ALT and diarrhea (6.8% each). Eight patients discontinued due to any-grade related AEs. No grade 3-4 pneumonitis was seen.
The results showed encouraging antitumor activity in both dose cohorts, with most responses ongoing, and support the company's plans to initiate a Phase 3 trial evaluating the combination regimen of nivolumab and ipilimumab as a potential treatment option in treatment-naive patients by the end of 2014.
Key Efficacy Results in Previously-Treated and Treatment Naive RCC Patients
NR = Not Reached
Data from additional cohorts of CheckMate -016, including in combination with sunitinib or pazopanib in previously treated patients, will also be presented at ASCO (Abstract #5010).