BeiGene presents results on anti-PD-1 antibody tislelizumab at CSCO

BeiGene presented clinical data on tislelizumab, an investigational anti-PD-1 antibody, in Chinese patients with lung cancers, in two oral presentations at the 21st Annual Meeting of the Chinese Society of Clinical Oncology, or CSCO, in Xiamen, China. “Advanced lung cancer is one of our focus areas for development of tislelizumab, where we hope to have an impact on the way patients are treated both in China and worldwide. This complex and difficult-to-treat disease has proven to be susceptible to treatment with immunotherapies,” commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology, at BeiGene. “The preliminary data presented today demonstrate that tislelizumab is generally well tolerated and has antitumor activity both as monotherapy and in combination with several chemotherapy regimens used in small cell and non-small cell lung cancer patients. We are hopeful that further study of tislelizumab may lead to a new treatment option for a broad array of patients with lung cancers.” The multi-center, open-label Phase 2 trial in China of tislelizumab in combination with chemotherapy enrolled 54 patients with previously untreated locally advanced or metastatic lung cancer. All patients received tislelizumab at 200 mg every three weeks, plus platinum doublet until disease progression. Patients with non-squamous non-small cell lung cancer, or NSCLC, received pemetrexed plus platinum; patients with squamous NSCLC received either paclitaxel plus platinum or gemcitabine plus platinum; and patients with small cell lung cancer, or SCLC, received etoposide plus platinum. As of the June 5, 2018 data cutoff, 35 patients remain on treatment. Treatment discontinuation due to adverse events, or AEs, occurred in three patients. Fifty-one patients had at least one post-baseline tumor assessment and were evaluable for efficacy. Objective responses were observed in 56 percent of 16 evaluable patients with non-squamous NSCLC; 80 percent in 15 evaluable patients with squamous NSCLC, cohort A; 67 percent in six patients with squamous NSCLC, cohort B; and 82 percent in 17 evaluable patients with SCLC. Data continue to mature with follow-up. AEs were considered manageable and reversible, with chemotherapy dose modifications or tislelizumab dose holds, except for one fatal event of myocarditis/myositis. Five patients experienced at least one grade greater than or equal to3 AE that were considered to be possibly related to tislelizumab. Immune-related AEs occurred in 13 patients and included hypothyroidism, decreased tri-iodothyronine, hyperthyroidism, pneumonitis, pyrexia, and rash.
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