RE:RE:RE:RE:CD8+ TiLs and T-cell exhaustion
It is nice to see companies being accepted for AA....
From the Iovance PR
The FDA approval is based on safety and efficacy results from the C-144-01 clinical trial. C-144-01 is a global, multicenter trial investigating AMTAGVI in patients with advanced melanoma previously treated with anti-PD-1 therapy and targeted therapy, where applicable. AMTAGVI demonstrated deep and durable responses. The primary efficacy analysis set included 73 patients from Cohort 4 who received the recommended AMTAGVI dose from an approved manufacturing facility.
Of note the AA was based on a patient population of 73 patients and they have a confirmatory phase 3 trial in place which to my understanding is a requirement by the fda for approval.