The FDA will determine the acceptability of the BLA within the next 60 days.
Iovance Biotherapeutics has completed its biologics license application (BLA) for its tumor-infiltrating lymphocyte (TIL) therapy lifileucel for treating advanced melanoma.1
“Completing our BLA submission for lifileucel is a critical step forward in our journey to deliver the first individualized, 1-time cell therapy for a solid tumor. I would like to acknowledge the patients and physicians who participated in the C-144-01 clinical trial and the FDA review team for their commitment and support, as well as our internal team for their tremendous effort in completing the first BLA submission for Iovance,” Frederick Vogt, PhD, JD, interim president and chief executive officer, Iovance, said in a statement.1 “Our preparations for commercialization remain on track to support a launch later this year. We look forward to continued collaboration with the FDA as they review this new class of treatment for advanced melanoma patients with limited options.”
The BLA submission was originally planned to be completed in the fourth quarter of 2022 but was delayed after the FDA requested supplemental validation information and comparability data on lifileucel.2 The therapy is intended to treat unresectable or metastatic melanoma that progressed on or after prior anti-PD-1/L1 therapy, and if BRAF mutation positive, also prior BRAF or BRAF/MEK inhibitor therapy. Lifileucel most recently demonstrated positive data from the phase 2 C-144-01 clinical trial (NCT02360579) in this indication in late 2022 with an objective response rate (ORR) of 31.4%, a median duration of response (DOR) not reached at a median follow up of 36.5 months, and 41.7% of responding patients reaching a DOR of 24 months or more.3 Median overall survival (OS) was 13.9 months, and the 12-month OS rate was 54% (95% CI: 45.6%, 61.6%). The safety profile was manageable, with most TEAEs transient and consistent with lymphodepletion and IL-2.
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“MRA congratulates Iovance for completing the BLA submission and moving closer toward making TIL therapy an option for people with advanced melanoma who have progressed following prior treatments,” Marc Hurlbert, PhD, chief executive officer, Melanoma Research Alliance, added to the statement.1 “We hope for an FDA approval as quickly as possible for patients with significant unmet need who have no approved treatment options.”
Lifileucel, in combination with pembrolizumab, is also being assessed in the recently announced, phase 3 confirmatory TILVANCE-301 study which is primarily assessing ORR and progression free survival. The study will support full approval of lifileucel in post-anti-PD-1 advanced melanoma and will support another indication for frontline treatment of advanced melanoma.