New analysis of MYSTIC trial of Imfinzi monotherapy or Imfinzi + tremelimumab was presented at the ESMO Immuno-Oncology Congress- AstraZeneca
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.
Related news and insights
Genentech/Roche announced that the FDA has approved Susvimo (ranibizumab injection) 100 mg/mL for intravitreal use via ocular implant for the treatment of people with wet, or neovascular, age-related macular degeneration (AMD) who have previously responded to at least two anti-vascular endothelial growth factor (VEGF) injections.
Oncopeptides announced that the company has decided to withdraw Pepaxto (INN melphalan flufenamide) from the market in the US, following the phase III OCEAN study, which showed an overall survival in the ITT population with a HR of 1.104. The decision has been made after interactions and dialogue with the FDA. Pepaxto was granted accelerated approval on February 26th 2021.
Johnson & Johnson announced the FDA has issued Emergency Use Authorization (EUA) for a booster dose of the Johnson & Johnson COVID-19 vaccine for adults aged 18 and older at least two months following primary vaccination with single-shot Johnson & Johnson COVID-19 vaccine; and for eligible individuals who received a different authorized or approved COVID-19 vaccine.