Legend Biotech Phase 3 Study of Carvykti Meets Primary Endpoint

By Robb M. Stewart

Legend Biotech Corp. said Friday its late-stage study of a treatment for adult patients with relapsed and lenalidomide-refractory multiple myeloma met its main target.

The biotechnology company said its Phase 3 study evaluating Carvykti met the primary endpoint of showing a statistically significant improvement in progression-free survival compared with standard therapy at the study's first pre-specified interim analysis. The study has been unblinded following the recommendation of an independent data monitoring committee.

In premarket trading, Legend's American depositary receipts were 3.1% higher on Nasdaq after ending the previous session at $53.84, up roughly 50% over the last 12 months.

The Cartitude-4 study is the first international, randomized, open-label Phase 3 study evaluating the efficacy and safety of a CAR-T therapy versus pomalidomide, bortezomib and dexamethasone or daratumumab, pomalidomide and dexamethasone in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy, Legend said.

Secondary endpoints for the study include safety, overall survival, minimal residual disease negative rate and overall response rate. Patients will continue to be followed for primary and secondary endpoints as part of the Cartitude-4 study.

Legend said results from the study would be submitted to an upcoming medical meeting and will support its discussions with health authorities about potential regulatory submissions.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

January 27, 2023 09:09 ET (14:09 GMT)

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