Iovance updates pipeline: BLA under review, NSCLC trial on hold

IOVANCE BIOTHERAPEUTICS, INC.

BLA for lifileucel in advanced melanoma under FDA review; pre-license inspection of iCTC facility completed in 2023.
Clinical hold placed on IOV-LUN-202 NSCLC trial on Dec 22, 2023; enrollment paused, prior patients continue monitoring.
Phase 2 C-144-01 pooled melanoma data: ORR 31.4%, median DOR not reached, 41.7% of responses lasting ≥24 months.
Phase 3 TILVANCE-301 frontline melanoma trial first patient randomized in 2Q23; dual primary endpoints ORR and PFS.
Cash $428M as of Sep 30, 2023; Proleukin acquisition for £167.7M upfront closed May 2023.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.