Shares of Legend Biotech (NASDAQ: LEGN) jumped an impressive 19.64% in a single day, attributed by industry media to the recent leak of positive data from the ongoing Phase III CARTITUDE-4 study. The study is assessing Legend’s BCMA-targeted chimeric antigen receptor (CAR) T cell therapy, Carvykti (ciltacabtagene autoleucel), as a second-line or later treatment for multiple myeloma (MM).
CARTITUDE-4 Study Results and Implications for Treatment
According to a report from STAT News, the CARTITUDE-4 trial demonstrated a 74% reduction in the risk of disease progression compared to standard treatment, along with a 22% decrease in the risk of death versus chemotherapy. These results suggest that US physicians may consider using Carvykti as a first-line therapy in the future. Legend is developing Carvykti in partnership with Johnson & Johnson (J&J) subsidiary Janssen Biotech and secured initial approval for the drug in the United States as a fourth-line MM treatment in March 2022.
Recommendation to Unblind Trial and Upcoming Data Presentations
In January of this year, the independent data monitoring committee for the CARTITUDE-4 study recommended unblinding the trial due to positive treatment effects, aiming to secure approval for an earlier treatment setting. However, the exact data was not released at that time. The Phase III CARTITUDE-4 study enrolled 419 patients with relapsed and lenalidomide-refractory MM who had previously received 1 to 3 prior lines of therapy, including a proteasome inhibitor (PI) and an immunomodulatory drug (IMiD). Janssen and Legend have declined to comment further, stating that full data from the study will be presented at the European Hematology Association and American Society of Clinical Oncology meetings in May this year.
Private Share Issuance and Impact on Share Price
Separately, Legend issued an SEC statement on April 19, 2023, revealing a private placement of shares worth USD 200 million to an ‘institutional investor’. Specifically, 7,656,968 ordinary shares were placed at a purchase price of USD 26.12 per share, which may also have influenced the firm’s share price.-Fineline Info & Tech
