Iovance Biotherapeutics Syas FDA Lifts Partial Clinical Hold on LN-145

By Chris Wack

Iovance Biotherapeutics said the U.S. Food and Drug Administration lifted a partial clinical hold placed on the registrational trial investigating LN-145 tumor infiltrating lymphocytecell therapy in non-small cell lung cancer.

In collaboration with the FDA and an independent data monitoring committee, the biotechnology company developed additional safety measures and monitoring.

Upon reviewing this proposal, the FDA has cleared Iovance to resume patient enrollment in the trial.

The trial is investigating LN-145 in patients with advanced non-small cell lung cancer who were previously treated with chemotherapy and anti-PD-1 therapy and at least one line of an approved targeted therapy if indicated by other actionable tumor mutations.

Iovance expects to complete enrollment of 120 patients in the registrational cohorts trial in 2025.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

March 04, 2024 06:59 ET (11:59 GMT)

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