- Iovance (NASDAQ:IOVA) tanks 24% after hours, as it has not reached agreement with the FDA on the required potency assays to fully define its tumor-infiltrating lymphocyte therapy lifileucel in metastatic melanoma.
- Company is continuing to refine the information from its current potency assays and simultaneously developing additional assays
- As a result, a marketing application submission is not expected this year; company expects a submission will occur in 2021
- According to the company, clinical data from its C-144-01 trial supports the potential for lifileucel as a treatment for metastatic melanoma.
- As previously announced, updated Phase 2 Cohort 2 data showed an overall response rate (ORR) of 36.4% with a median duration of response not reached at 18.7 months of median study follow up (n=66).
- Early Cohort 4 data showed an ORR of 32.4% at 5.3 months of median study follow up (n=68).
- https://seekingalpha.com/news/3619963-iovance-pushes-lifileucels-us-application-submission-next-year
Monday, October 5, 2020
Iovance pushes lifileucel's US application submission into next year
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