- Yesterday the FDA asked Iovance Biotherapeutics Inc IOVA for more data on the assays for lifileucel US application. Now the company announced additional clinical data for lifileucel alone and in combination with pembrolizumab in advanced melanoma.
- Data will be presented at the upcoming ASCO 2021 Annual Meeting.
- The company said it is reporting for the first time, results for lifileucel as an earlier treatment in combination with Merck & Co Inc's MRK Pembrolizumab (Keytruda), demonstrating an overall response rate (ORR) of 86% in patients who are naïve to anti-PD-1 therapy.
- One patient achieved complete response (CR), and 5 Partial Responses (PR) were reported.
- The longest duration of response was 16.8 months.
- New data in the ASCO abstract suggest that Duration of Response was positively associated with shorter cumulative duration of prior anti-PD-1 therapy. In responders, the median cumulative duration and median prior lines of anti-PD-1 therapy were 4.4 months and 1.5 lines.
- Additional data updates will be provided at ASCO 2021 Meeting.
- Price Action: IOVA shares gained 17.4% at 19.17 during the market session on the last check Thursday.
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