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Conclusions on clinical efficacy (EPAR)
European Public Assessment Report , EMA/246304/2016, page 51
“In summary, there are differences in early death rates between these patient population (PD-L1 <10%) and the patient population defined
by a PD-L1 expression >10%. At 3 months, the OS rate is 72% vs. 90% in favour of the patients with a high PD-L1 expression. Therefore,
it cannot be ruled out that the baseline PD-L1 expression percentage may affect the early death rate
.”