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CHMP Recommends Approval for BeiGene's Tislelizumab in First-Line PD-L1-Positive NSCLC

NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) on Monday recommended approval for BeiGene's anti-PD-1 antibody tislelizumab across three lung cancer indications, including for biomarker-selected non-small cell lung cancer patients.

CHMP recommended tislelizumab plus pemetrexed and platinum-containing chemotherapy as a first-line treatment for locally advanced or metastatic non-squamous NSCLC patients whose tumors have PD-L1 expression on greater than 50 percent of tumor cells and who have no EGFR or ALK mutations. The authority also recommended tislelizumab in combination with carboplatin and either paclitaxel or nab-paclitaxel for the first-line treatment of patients with squamous NSCLC and as a monotherapy treatment for locally advanced or metastatic NSCLC after prior platinum-based therapy.

The recommendation for PD-L1-positive NSCLC patients was based on data from the Phase III RATIONALE 304 trial. Results from that study demonstrated a median progression-free survival of 9.7 months for tislelizumab in combination with platinum chemo and pemetrexed versus 7.6 months for platinum and pemetrexed alone and 14.6 months with tislelizumab in combination with chemotherapy versus 4.6 months with chemotherapy alone. BeiGene also submitted results from the Phase III RATIONALE 307 and RATIONALE 303 trials to support the other all-comer indications.

"Through three Phase III clinical trials enrolling nearly 1,500 patients across the world including in the European Union, tislelizumab has been shown to be an effective therapy for patients with treatment-naïve and treatment-resistant NSCLC," Mark Lanasa, chief medical officer for solid tumors at BeiGene, said in a statement. "As we strengthen our global portfolio in solid tumors, this positive CHMP opinion marks another significant milestone in the European Union for tislelizumab only a few months after it was approved for the treatment of advanced esophageal squamous cell carcinoma."

In Europe, tislelizumab is already approved for an all-comer population of advanced or metastatic esophageal cancer, and the US Food and Drug Administration is reviewing an application in the same indication. Tislelizumab was approved in China in 2020 for the treatment of PD-L1 high expressing advanced or metastatic urothelial carcinoma.

BeiGene, based in Beijing, is also studying tislelizumab in a Phase III study in nasopharyngeal cancer. In 2022, the firm presented data from this trial demonstrating the drug performed better in patients with "hot" gene expression signatures. The firm is also studying tislelizumab with Hutchmed's VEGFR inhibitor fruquintinib in advanced triple-negative breast cancer or endometrial cancer.