Chinese Regulator Accepts BeiGene’s Tislelizumab sBLA for Nasopharyngeal Cancer

Beijing-based biotech BeiGene is now one step closer to getting another of its immunotherapies approved in China. On August 22nd, it announced that the Center for Drug Evaluation of China’s NMPA had accepted a supplemental Biologics License Application (sBLA) for anti-PD-1 antibody tislelizumab in combination with chemotherapy as a first-line treatment for patients with recurrent or metastatic nasopharyngeal cancer (NPC).

Phase 3 Clinical Trial Meets Primary Endpoint

The sBLA is supported by positive data from a Phase 3 clinical trial on tislelizumab, which the company announced in late May.

BeiGene’s RATIONALE 309 trial is a randomized, double-blind Phase 3 clinical trial (NCT03924986) that evaluates the efficacy and safety of tislelizumab combined with gemcitabine and cisplatin versus a placebo combined with gemcitabine and cisplatin as a first-line treatment for patients with recurrent or metastatic NPC.

At the interim analysis, an independent review committee determined that the trial has met its primary endpoint of progression-free survival (PFS). Results showed that patients who received the tislelizumab combo had a statistically significant improvement in their PFS compared to the placebo control.

No notable adverse events outside the drug’s established risks were detected when the chemotherapy was added.

The NMPA has either fully or conditionally approved tislelizumab in four indications that cover patients with advanced non-small cell lung cancer (NSCLC), classical Hodgkin’s lymphoma (cHL), and locally advanced or metastatic urothelial carcinoma (UC) with high PD-L1 expression.

The regulator’s Center for Drug Evaluation has also accepted three sBLAs for tislelizumab as first-line treatment of patients with advanced non-squamous NSCLC, second-or third-line treatment of patients with locally advanced or metastatic NSCLC, and patients with previously treated unresectable hepatocellular carcinoma.

In January 2021, BeiGene and Novartis entered into a collaboration and licensing agreement, which granted the latter rights to develop and distribute tislelizumab for commercial use in North America, Europe, and Japan.

How Does Tislelizumab Work?

Tislelizumab (BGB-A317) is a humanized IgG4 anti-PD-1 monoclonal antibody specifically designed to minimize binding to the Fc receptor (FcR) on macrophages.

Some cancer cell types express PD-1 ligands on their surfaces, which bind to the PD-1 receptor on T cells. This binding tells the T cell to leave the cancer cell alone, allowing it to escape destruction.

The anti-PD-1 antibody tislelizumab blocks PD-1 without activating the receptor. This prevents PD-1 ligand-receptor interactions, which restores the ability of the T cells to destroy the cancer cell.

FcR on macrophages can bind to antibodies that block PD-1 on T cells. This stimulates the macrophage to kill the T cell, which ultimately hampers the immune response.

What Else Does BeiGene Do?

BeiGene is a global biotech founded in 2010 by Chinese-American scientist Xiaodong Wang and American entrepreneur (and current CEO) John V. Oyler. It is an R&D powerhouse for cancer treatments, with a broad portfolio of more than 40 clinical drug candidates.

BeiGene collaborates widely with pharma giants like Amgen and Novartis. One of its immunotherapies, zanubrutinib, is the first anti-cancer drug developed in China to be approved by the FDA. It was given accelerated approval to treat mantle cell lymphoma (MCL) in November 2019. It has since been approved in China to treat MCL, chronic lymphocytic leukemia, and small lymphocytic lymphoma.

Author

Joy Lin

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