Lifileucel

Unassigned

New Medicines

Malignant melanoma in patients who have progressed on prior checkpoint targeted therapy

Information

Advanced therapy medicinal product (ATMP)
Iovance Biotherapeutics
Iovance Biotherapeutics

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials
Yes
Apr 20 · Iovance also reports that it began construction of a state-of-the-art, 136,000 square foot commercial-scale production facility in Philadelphia for its TIL therapies in Jun 19. The new facility is expected to be completed by year-end 2021 to support commercial supply in 2022 [4].
Apr 20 · Iovance reports in final year results that patient dosing in the pivotal cohort 4 of the C-144-01 study completed in Jan 20, three months ahead of schedule. Iovance intends to submit a biologics license application (BLA) to FDA subsequent to consultation with the agency in 2020 [4].
Apr 20 · US FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation for lifileucel in advanced melanoma based on data from the C-144-01 trial [3].
Apr 20 · Has orphan drug status and fast track status in US [3].
Oct 18 · Iovance Biotherapeutics announces completion of End of PII meeting with the US FDA. FDA acknowledged the potential acceptability of a single-arm cohort for registration. And that conduct of a randomized PIII trial may not be feasible in its intended population of advanced melanoma patients who have been treated with at least one systemic therapy including a PD-1 blocking antibody and if BRAF V600 mutation positive, a BRAF inhibitor or BRAF inhibitor with MEK inhibitor and is not required for initial registration of lifileucel. As a result, the company has decided to expand the ongoing C-144-01 trial with an additional cohort with a primary endpoint of overall response rate [3].

Category

Ready-to-infuse product consisting of tumour-infiltrating lymphocytes (TILs) isolated from a patient's own tumours. These therapeutic TILs are expanded in vitro to several billion cells before being infused, typically with a high dose of interleukin-2.
In 2011, the UK age-standardised incidence of melanoma for females was 17.6 (11.7 in 2001) and for males 17.5 (10.1 in 2001) per 100,000 population [1].
Malignant melanoma in patients who have progressed on prior checkpoint targeted therapy
Intravenous infusion

Trial or other data

Jan 20 · PII innovaTIL-01 trial is active but no longer recruiting [2].
Sep 15 · PII innovaTIL-01 trial to evaluate the safety and efficacy of lifileucel in patients with metastatic melanoma who have progressed on prior checkpoint targeted therapy starts (C-144-01; NCT02360579). Lifileucel is an autologous adoptive cell transfer therapy that utilizes a TIL manufacturing process, as originally developed by the NCI, for the treatment of patients with metastatic melanoma. The adoptive cell transfer therapy used in this study involves patients receiving a lymphocyte depleting preconditioning regimen, prior to infusion of autologous TIL, followed by the administration of a regimen of IL-2. 178 adults will be recruited in the US, France, Germany, Hungary, Italy, Spain, Switzerland and the UK; UK sites are Royal Marsden (London), Beatson West of Scotland Cancer Centre (Glasgow), Addenbrookes Hospital (Cambridge) and Sarah Cannon Research Institute (London). Primary outcome is objective response rate; collection of these data is due to complete Jul 20 [2].

Evidence based evaluations