Legend Biotech Phase 3 Study of Carvykti Meets Primary Endpoint
January 27 2023 - 09:24AM
Dow Jones News
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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