AstraZeneca’s Imfinzi recommended for approval in EU by CHMP

AstraZeneca’s (AZN) Imfinzi has been recommended for approval in the European Union, EU, as monotherapy for the treatment of adults with limited-stage small cell lung cancer, LS-SCLC, whose disease has not progressed following platinum-based chemoradiation therapy, CRT. The Committee for Medicinal Products for Human Use, CHMP, of the European Medicines Agency, EMA, based its positive opinion on the results from the ADRIATIC Phase III trial, which were published in The New England Journal of Medicine. Results showed Imfinzi reduced the risk of death by 27% versus placebo. Estimated median OS was 55.9 months for Imfinzi versus 33.4 months for placebo. An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% for placebo. Imfinzi also reduced the risk of disease progression or death by 24% versus placebo. Median PFS was 16.6 months for Imfinzi versus 9.2 months for placebo. An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% for placebo.