Cellular Therapy Approaches Late-Breaking AbstractTitle: Novel Cryopreserved Tumor Infiltrating Lymphocytes (LN-144) Administered to Patients with Metastatic Melanoma Demonstrates Efficacy and Tolerability in a Multicenter Phase 2 Clinical Trial Authors: Sarnaik, et al. Poster #: 515 Presentation date: Friday, November 10, 2017 Key Takeaways:
- Preliminary efficacy data from nine patients in Cohort 2 shows a DCR of 78% including three partial responses and a fourth awaiting confirmation.
- Preliminary data to date show that the safety profile of Gen 2 LN-144 therapy is similar to Gen 1 LN-144 therapy previously presented at ASCO 2017. The most common adverse events reported were pyrexia, anaemia and nausea.
- The Iovance Generation 2 manufacturing process produces a potentially potent TIL product with comparable quality attributes to the Generation 1 manufacturing process.
- The abbreviated 22-day expansion platform allows for the rapid generation of TIL product for patients in urgent need of therapy. The cryopreserved product also offers flexibility of patient dosing.
- The cryopreserved drug product introduces critical logistical efficiencies allowing flexibility in distribution, and overcomes traditional barriers to the wider application of TIL therapy.
- Commercial manufacturing of TIL products will require a robust analytical platform to ensure consistent delivery of products meeting the critical quality attributes of cellular therapeutics.
- Study shows TIL products manufactured by Iovance are composed of greater than 99% CD45+CD3+ T cells.
- Residual melanoma cells in TIL products were below the limit of detection using a specialized assay developed for this assessment.
- This study demonstrates the positive effects of adding IL-15 and IL-21 to the standard IL-2-containing cell culture in an ex vivo TIL generation protocol.