Bristol-Myers Squibb announced topline results from the CheckMate-459 phase 3 trial of Opdivo (nivolumab) as first line treatment in patients with unresectable hepatocellular carcinoma (HCC).
The CheckMate-459 trial was a multicenter, open label, randomized study that evaluated the efficacy of Opdivo compared with sorafenib in patients with unresectable HCC. Patients were treated until disease progression or unacceptable toxicity. The primary endpoint was overall survival (OS); secondary endpoints included progression-free survival (PFS), programmed death (PD)-L1 expression, and overall response rate (ORR).
Findings from the study demonstrated Opdivo did not achieve statistical significance for OS (HR=0.85 [95% CI: 0.72-1.02]; P =.0752). Regarding safety, no new treatment-emergent adverse events were seen with Opdivo. The Company will present the full study results at an upcoming medical meeting.
“We remain confident in the important role of Opdivo for the treatment of patients with HCC and look forward to evaluating insights garnered from this trial with the goal of ensuring patients with liver cancer have the opportunity to achieve the best possible outcomes,” Ian M. Waxman, MD, development lead, Gastrointestinal Cancers, Bristol-Myers Squibb, commented.
Opdivo is a human programmed death receptor-1 (PD-1)-blocking antibody. It is currently indicated to treat HCC in patients previously treated with sorafenib, lung cancer, head and neck cancer, renal cancer, urothelial cancer, colorectal cancer, lymphoma, and melanoma.
For more information visit opdivo.com.