Iovance nag-ulat ng 26% ORR, hindi pa naaabot ang mDOR para sa lifileucel sa NSCLC

Ang interim data ng IOV-LUN-202 trial ay nagpapakita ng 26% objective response rate at hindi pa naaabot ang median duration of response pagkatapos ng >25 buwan na follow-up sa previously treated advanced nonsquamous NSCLC. Ang FDA ay nagbigay na ng positive feedback sa trial design at potency assay matrix; inaasahan ng kumpanya ang trial completion sa 2026 upang suportahan ang supplemental BLA na may potensyal na launch sa 2027.

Mahahalagang fact

Na-file: Nob 6, 2025, 01:05 PM
Kaganapan: Topline na resulta
Direksyon: Positibo
Kumpanya: IOVAIovance
Asset: lifileucel
Pinagmulan: SEC 8-K
Kumpiyansa: May source
DCR: 100%
cORR: 40%
Panggitnang naunang linya ng paggamot: 2

Sipi mula sa source

EX-99.1 2 tm2530236d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Iovance Biotherapeutics Highlights Business Achievements, Pipeline Milestones, and Third Quarter 2025 Results Quarterly Revenue Growth of 13% to ~$68 Million Gross Margin Increased to 43% on Improved Execution and Operational Efficiency Best-in-Class Clinical Profile for Lifileucel in Previously Treated Advanced Non-Small Cell Lung Cancer (NSCLC) with Median Duration of Response Not Reached after 25+ Months Follow Up SAN CARLOS, Calif., November 6, 2025 -- Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, today reported third quarter and year-to-date 2025 fi

SEC 8-K

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