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The first TIL cell therapy submits a rolling marketing application

 Last Update: 2022-09-06
 Source: Internet
 Author: User

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On August 25, 2022, Iovance Biotherapeutics announced the initiation of a rolling marketing application for the TIL therapy lifileucel for the treatment of advanced melanoma that has progressed after PD-1/PD-L1 therapy.

Lifileucel is Iovance's first-in-line pipeline, with multiple monotherapy and combination clinical studies in progress

TIL therapy separates infiltrating lymphocytes from tumors, expands them in vitro, and then infuses them back into patients.

Iovance's next-generation production process requires a 22-day preparation cycle

The Phase II clinical trials of Lifileucel are divided into 4 cohorts

The ORR for cohort 2 was 36%, and the mDOR has not yet been reached

The ORR for cohort 4 was 29%, the mDOR was 10.

Eighty-three percent of patients in cohort 4 had received CTLA-4 antibody therapy, and 55% had received combined PD-1+CTLA-4 therapy

The Lifileucel+Keytruda combination in immunotherapy-naive melanoma had an ORR of 66.

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