Phase 3 trial of tislelizumab in hepatocellular carcinoma meets survival endpoint
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A phase 3 trial of the PD-1 inhibitor tislelizumab met its primary endpoint of noninferior OS compared with sorafenib as first-line treatment for adults with unresectable hepatocellular carcinoma, according to the agent’s manufacturer.
Tislelizumab (BGB-A317, BeiGene) is a humanized immunoglobulin G4 monoclonal antibody designed to minimize binding to Fc-gamma receptors on macrophages, which may result in anti-PD-1 resistance. The agent is under development as monotherapy and in combination with other treatments for a variety of malignancies, including esophageal cancer.
The randomized, open-label RATIONALE 301 study compared tislelizumab with sorafenib (Nexavar, Bayer) as first-line treatment among more than 600 patients with unresectable HCC in the U.S., Europe and Asia. Noninferiority of OS between the treatment cohorts served as the primary endpoint, with overall response rate, PFS, durability of response, time to progression, health-related quality of life measures, safety and tolerability as secondary endpoints.
In addition to meeting the primary endpoint, tislelizumab exhibited a safety profile consistent with prior studies of the agent, with no new safety signals.
“Patients with unresectable HCC face a devastating prognosis, with a median life expectancy of 1 year. Currently, there are few treatment options if patients cannot tolerate [tyrosine kinase inhibitor] therapy or if their condition progresses,” Mark Lanasa MD, PhD, chief medical officer for solid tumors at BeiGene, said in a company-issued press release. “We are encouraged by the outcome of the final analysis of RATIONALE 301 and look forward to sharing the full safety and efficacy results at an upcoming medical conference.”
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