BeiGene Announces that the Phase 3 Clinical Trial of its Anti-PD-1 Antibody Tislelizumab in Patients with First-Line Squamous Non-Small Cell Lung Cancer Met the Primary Endpoint of Progression-Free Survival at Interim Analysis
January 21, 2020 at 07:00 am
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BeiGene, Ltd. announced that the pivotal Phase 3 trial evaluating its anti-PD-1 antibody tislelizumab in combination with two chemotherapy regimens for the first-line treatment of patients with squamous non-small cell lung cancer (NSCLC), met the primary endpoint of improved progression-free survival (PFS) at the planned interim analysis, as assessed by independent review committee (IRC). In this study, patients with previously untreated advanced squamous NSCLC were randomized to receive either tislelizumab in combination with paclitaxel and carboplatin, tislelizumab in combination with nanoparticle albumin-bound (nab) paclitaxel (ABRAXANE®) and carboplatin, or paclitaxel and carboplatin alone. Based on the pre-planned interim analysis, both tislelizumab treatment arms crossed the pre-specified efficacy boundary compared to chemotherapy alone. The safety profile of tislelizumab in both combinations in this trial was consistent with the known risks of each study treatment, and no new safety signals were identified. The company plans to discuss its plans for filing a supplemental new drug application (sNDA) for tislelizumab as a first-line treatment for squamous NSCLC with the Center for Drug Evaluation (CDE) at the National Medical Products Administration (NMPA) in China and to present these data at an upcoming medical meeting. This trial (NCT 03594747, known as BGB-A317-307) is a Phase 3, randomized, open-label, multi-center trial investigating tislelizumab combined with either paclitaxel and carboplatin or nab-paclitaxel (ABRAXANE, which is commercialized by BeiGene in China) and carboplatin compared with paclitaxel and carboplatin alone in patients with untreated stage IIIB or IV squamous NSCLC from mainland China, regardless of PD-L1 expression. The primary endpoint is PFS per IRC. Key secondary endpoints include overall survival and safety. The study began enrolling patients in July 2018, and 360 patients were randomized 1:1:1 to receive tislelizumab (200mg every three weeks) in combination with each of the chemotherapy regimens or chemotherapy only, until disease progression, unacceptable toxicity, physician decision or consent withdrawal. Patients on the chemotherapy-only control arm who experienced disease progression, verified by central independent review, were eligible to cross over to receive tislelizumab monotherapy. Squamous NSCLC remains a significant unmet need, representing approximately 30% of patients with NSCLC in China. This Phase 3 study was designed to assess the impact of tislelizumab given in combination with chemotherapy as a potential treatment to improve outcomes in patients with advanced squamous NSCLC, for whom prognoses are typically quite poor.
BeiGene, Ltd. is a global biotechnology company engaged in discovering and developing oncology treatments for cancer patients worldwide. The Company has discovered and developed three approved medicines, including BRUKINSA, a small molecule inhibitor of Brutonâs Tyrosine Kinase for the treatment of various blood cancers; TEVIMBRA (tislelizumab), an anti-PD-1 antibody immunotherapy for the treatment of various solid tumor and blood cancers; and pamiparib, a selective small molecule inhibitor of poly ADP-ribose polymerase 1 (PARP1) and PARP2. The Company has obtained approvals to market BRUKINSA in the United States, the People's Republic of China (China or the PRC), the European Union, the United Kingdom, Canada, Australia, and additional international markets; tislelizumab in the European Union and China; and pamiparib in China. It also focuses on commercializing cancer medicines, such as XGEVA, BLINCYTO, KYPROLIS, and others in China under an exclusive license from Amgen Inc.
BeiGene Announces that the Phase 3 Clinical Trial of its Anti-PD-1 Antibody Tislelizumab in Patients with First-Line Squamous Non-Small Cell Lung Cancer Met the Primary Endpoint of Progression-Free Survival at Interim Analysis