The NMPA approval was based on positive results from a single-arm, multi-centre, open-label Phase 2 trial that evaluated the efficacy and safety of tislelizumab

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NMPA expands Tislelizumab indication in China. (Credit: Arek Socha from Pixabay)

BeiGene has received China’s National Medical Products Administration (NMPA) conditional approval for tislelizumab to treat solid tumours in certain populations.

The drug was indicated for advanced unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours in adults with previously treated advanced colorectal cancer (CRC).

In addition, it was indicated for patients with other advanced solid tumours whose disease progressed after prior treatment, with no adequate alternative treatment options.

Tislelizumab is a humanised monoclonal antibody directed against PD-1, specifically designed to minimise binding to FcγR on macrophages.

The drug has been approved in China to treat patients with classical Hodgkin’s lymphoma (cHL) and with metastatic urothelial carcinoma (UC), among other indications.

BeiGene solid tumours chief medical officer and senior vice president Mark Lanasa said: “Results from the clinical trial of tislelizumab in patients with MSI-H and dMMR solid tumours demonstrated that tislelizumab’s treatment effect was consistent and durable across tumour types and endpoints.”

BeiGene China president, chief operating officer, and general manager Xiaobin Wu said: “With seven approved indications in China, our 3,100+ science-based commercial team is working to make tislelizumab more broadly available to those who may benefit from this important immunotherapy.”

The NMPA approval was based on positive results from a single-arm, multi-centre, open-label Phase 2 trial that evaluated the efficacy and safety of tislelizumab in 80 patients, in China.

In the study, patients received tislelizumab 200mg intravenously every three weeks until disease progression, unacceptable toxicity, or withdrawal.

Objective response rate (ORR) as assessed by the independent review committee (IRC) is the primary endpoint of the clinical trial.

The secondary endpoints include time to response (TTR), duration of response (DoR), disease control rate (DCR), progression-free survival (PFS) overall survival (OS), and safety and tolerability.

Clinical trial principal investigator vice president Lin Shen said: “In the pivotal Phase 2 trial, we observed consistent responses across tumour types with tislelizumab and it was generally well tolerated.

“The NMPA’s approval of tislelizumab is welcoming news to patients with MSI-H and dMMR solid tumours, which are particularly prevalent among the many patients with cancers of the gastrointestinal tract.

“We are pleased to have a tissue-agnostic treatment approach with tislelizumab now available to those patients in need.”

In January last year, Novartis signed a collaboration and license agreement with BeiGene to develop, manufacture and commercialise tislelizumab in markets outside of China.