SINGAPORE and LUGANO, Switzerland, December 20, 2015 /PRNewswire/ --
KEYNOTE-010 data further supports broadening pembrolizumab availability for all advanced NSCLC patients with PD-L1 expression over 1%
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More patients with advanced non-small-cell lung cancer (NSCLC) could benefit from pembrolizumab, says Professor Roy Herbst, Chief of Medical Oncology, Yale Cancer Center and Smilow Cancer Hospital at Yale-New Haven, presenting promising results from the pivotal phase 2/3 KEYNOTE-010 trial at the first ESMO Asia Congress in Singapore (1), in conjunction with a publication in The Lancet (2).
The study shows that two doses of the anti-PD-1 antibody pembrolizumab, the US Food and Drug Administration (FDA)-approved 2 mg/kg dose and an investigational 10 mg/kg dose, each given every 3 weeks, improve median survival in all PD-L1-positive patients compared with the commonly used chemotherapeutic agent docetaxel. The benefit is even greater in the group of patients with PD-L1 staining in ≥50% of tumour cells.
The open-label KEYNOTE-010 is the first study to assess the benefits of immunotherapy as second- or later line in patients with refractory lung cancer selected for PD-L1 expression. From August 2013 to April 2015, 1034 patients with advanced NSCLC from 24 countries (EU nations, US and Asia, including Japan, South Korea and Taiwan) were randomised to pembrolizumab (2 mg/kg or 10 mg/kg) or docetaxel. All patients had experienced disease progression after platinum-containing systemic therapy and were stratified by PD-L1 expression level (tumour proportion score, TPS ≥50% vs 1-49%).
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SOURCE European Society for Medical Oncology (ESMO)