Beigene’s Tislelizumab-Chemo Combo Nails Primary Endpoint in Phase 3 Trial

On April 13th, the immuno-oncology company announced that its PD-1 monoclonal antibody, tislelizumab in combination with chemotherapy, extended progression free survival in patients with first-line non-squamous, Non-Small Cell Lung Cancer (NSCLC).

Beigene is a commercial-stage biotechnology company that strives to discover novel immuno-oncology drugs that could be developed and commercialized for treating cancers. It is the proud owner of Brukinsa (zanubrutinib), the first Chinese company-discovered anti-cancer drug to bag an FDA approval. The Bruton tyrosine kinase inhibitor was approved in the US for oral administration in patients with Mantle Cell Lymphoma (MCL) who received at least one prior therapy.

Among other investigational candidates currently in Beigene’s pipeline, tislelizumab, the first drug from its immuno-oncology biologics program, is a promising asset. After an interim analysis showed the drug-chemo combination improving survival in patients with first-line squamous NSCLC, it was predicted to rival Merck’s blockbuster drug Keytruda. Beigene has now announced that the combination therapy also met the primary endpoint in a Phase 3 trial in patients with first-line non-squamous NSCLC. The trial consisted of 334 patients randomized to receive either tislelizumab with pemetrexed and platinum chemotherapy or chemotherapy alone. The interim analysis shows that the combo regimen significantly extended the progression-free survival in patients.

Tislelizumab is a humanized monoclonal antibody that targets PD-1 and prevents its binding to PD-L1 and PD-L2 ligands. Therefore, it is an immune checkpoint inhibitor. The drug is already approved in China for treating patients with classical Hodgkin lymphoma (cHL) who have received at least two prior therapies. On April 10th, it received the second approval in the country for the treatment of previously treated or metastatic urothelial carcinoma. The drug is still evaluated as monotherapy for its efficacy in treating solid tumors and blood-related cancers.

“We are excited to announce the positive outcome in the interim analysis of this Phase 3 study of tislelizumab in first-line non-squamous NSCLC, following the positive interim analysis in first-line squamous NSCLC earlier this year,” said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. “These results add to our growing body of evidence demonstrating the efficacy and safety of tislelizumab for the treatment of advanced cancers. We look forward to continuing to evaluate tislelizumab in more than 25 studies, including 15 potentially registration-enabling trials.”

Related article: Innovent reports clinical trial results of its anti-PD-1 monoclonal antibody

References

1. https://www.beigene.com/science-and-product-portfolio/pipeline
2. https://www.brukinsa.com/
3. http://ir.beigene.com/news-releases/news-release-details/beigene-announces-phase-3-trial-tislelizumab-combined?loc=US
4. http://ir.beigene.com/news-releases/news-release-details/beigene-announces-phase-3-clinical-trial-its-anti-pd-1-antibody?loc=US
5. http://ir.beigene.com/news-releases/news-release-details/china-national-medical-products-administration-approves-0?loc=US

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