BeiGene has reported positive data from the international Phase III RATIONALE 301 clinical trial of tislelizumab as a first-line therapy for adult unresectable hepatocellular carcinoma (HCC) patients.
The randomised, open-label trial assessed tislelizumab versus sorafenib as a first-line therapy in adult unresectable HCC patients.
It enrolled over 600 subjects in the US, Europe and Asia.
Non-inferiority of overall survival (OS) between the two treatment arms was the trial’s primary endpoint.
The overall response rate, evaluated by Blinded Independent Review Committee (BIRC) per RECIST v1.1, was the trial’s key secondary endpoint.
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Progression-free survival, response durability and time to progression as per BIRC, measures of health-linked quality of life, safety and tolerability were the other secondary endpoints.
According to the findings, the trial met the primary endpoint with non-inferior OS compared to sorafenib.
Tislelizumab’s safety profile was in line with prior trials without any new safety signals observed.
A humanised IgG4 anti-PD-1 monoclonal antibody, tislelizumab lowers attachment to Fc-gamma (Fcγ) receptors on macrophages.
It aids the immune cells of the body in detecting and fighting tumours.
Tislelizumab is the first drug from the immuno-oncology biologics programme of BeiGene.
The company is developing the drug globally as a single agent and along with other therapies to treat various solid tumour and haematologic cancers.
BeiGene Solid Tumors chief medical officer Mark Lanasa said: “Patients with unresectable HCC face a devastating prognosis, with a median life expectancy of one year.
“Currently there are few treatment options if patients cannot tolerate TKI therapy or if their condition progresses.
“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.”
The company dosed the first subject in a Phase I trial of BGB-23339 to treat multiple immune-mediated disorders, in November last year.