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BeiGene announces positive phase 3 trial results for liver cancer treatment

There were more than 900,000 new cases in 2020 of the most common type of primary liver cancer – unresectable hepatocellular carcinoma


BeiGene has announced positive phase 3 trial results for tislelizumab as a first-line treatment in adults with the most common type of primary liver cancer – unresectable hepatocellular carcinoma (HCC).

HCC is the sixth most common type of cancer worldwide, the company reported, accounting for more than 900,000 new cases in 2020. Despite improvements in screening, surveillance rules and imaging, more than two-thirds of patients with HCC present with advanced disease at diagnosis.

The phase 3 RATIONALE 301 study is a global, randomised, open-label study of tislelizumab compared with sorafenib as a first-line treatment in adults with unresectable HCC. More than 600 patients in the US, Europe and Asia participated in the study.

The study met its primary endpoint of non-inferiority of overall survival (OS) between the two treatment groups. The safety profile for tislelizumab was consistent with previous studies and no new safety signals were reported.

Commenting on the positive results, Mark Lanasa, chief medical officer, Solid Tumours at BeiGene, 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 Tyrosine kinase inhibitor (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.”

Tislelizumab is a humanised immunoglobulin G4 monoclonal antibody designed to minimise binding to Fc gamma receptors on macrophages, which may result in anti-PD-1 resistance.

BeiGene has already secured approval for the PD-1 inhibitor in China for the treatment of non-small cell lung cancer (NSCLC), classical Hodgkin lymphoma, HCC and PD-L1-high urothelial carcinoma.

Through a collaboration and licence agreement with Novartis in January 2021, the Swiss-American pharma company has the rights to develop, manufacture and commercialise tislelizumab in North America, Europe and Japan.

Last month, Novartis announced positive results from a phase 3 trial showing tislelizumab plus chemotherapy significantly improved OS for patients with advanced oesophageal cancer, regardless of PD-L1 status.

Results from the RATIONALE 306 study showed tislelizumab plus chemotherapy reduced the risk of death by 34%, with the treatment demonstrating a median OS of 17.2 months, compared to 10.6 months in patients receiving chemotherapy plus a placebo.

Article by
Emily Kimber

10th August 2022

From: Research, Regulatory



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