Data from Pharmawand - Curated by EPG Health - Date added 20 December 2018

In a full analysis of the MYSTIC study of Imfinzi (durvalumab) monotherapy or Imfinzi + tremelimumab which was presented at the ESMO Immuno-Oncology 2018 congress in Geneva ,Naiyer Rizvi of the Columbia University Medical Center in New York who was study author, noted that while not reaching statistical significance, Imfinzi monotherapy gave a clinically meaningful median OS improvement of 16.3 months compared to 12.9 months with chemotherapy in patients with 25% or greater PD-L1 expression.

Moreover an exploratory analysis which examined survival according to the biomarker of high or low tumor mutational burden (TMB) in the blood – 16 or more mutations per megabase was defined as high and fewer than 16 as low. TMB evaluation was performed in more than 70% of patients, of whom 40% had high TMB and for those patients OS was 16.5 months with the Imfinzi/ tremelimumab combination versus 10.5 months with chemotherapy; OS with Imfinzi alone was 11 months.

The proportion of high TMB patients alive at two years was 39% with the combination, 30% with Imfinzi and 18% with chemotherapy, while in those with low TMB, OS was 8.5 months with Imfinzi plus tremelimumab, 12.2 months with Imfinzi and 11.6 months with chemotherapy.

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