Legend Biotech (LEGN) highlights CARVYKTI and LUCAR-G39D data at ASH 2025

Rhea-AI Filing Summary

Legend Biotech Corporation reported new clinical data on its CAR-T therapies presented at the 67th American Society of Hematology Annual Meeting in Orlando, Florida. Results from the CARTITUDE-1 and CARTITUDE-4 studies showed that a single infusion of CARVYKTI (ciltacabtagene autoleucel) provided long-term progression free survival benefit for patients with standard-risk relapsed or refractory multiple myeloma. The company also reported that earlier use of CARVYKTI in CARTITUDE-4 was associated with better immune fitness and stronger immune effects.

Beyond multiple myeloma, Legend Biotech highlighted early Phase 1 data for LUCAR-G39D in adults with relapsed or refractory B-cell non-Hodgkin lymphoma. In this ongoing study, LUCAR-G39D showed a manageable safety profile and encouraging antitumor activity, suggesting potential for further development within the company’s novel CAR-T platform.

Insights

Biotech clinical-stage analyst

ASH data highlight durability for CARVYKTI and early promise for LUCAR-G39D, reinforcing Legend Biotech’s CAR-T oncology pipeline momentum.

The update centers on new data for CARVYKTI from the CARTITUDE-1 and CARTITUDE-4 studies in standard-risk relapsed or refractory multiple myeloma. A single infusion providing long-term progression free survival benefit is important in this setting because durable disease control with one treatment can be clinically meaningful. CARTITUDE-4 also links earlier use of CARVYKTI to better immune fitness and stronger immune effects, which may inform how clinicians think about treatment timing.

Legend Biotech also reported early Phase 1 results for LUCAR-G39D in relapsed or refractory B-cell non-Hodgkin lymphoma. The description of a manageable safety profile and encouraging antitumor activity is typical of promising first-in-human CAR-T findings and supports continued development of this novel platform. Future detailed updates from this ongoing study and from CARTITUDE trials will help clarify how these therapies may fit into treatment landscapes over time.

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

Form 6-K

REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934

Date of Report: December 8, 2025

Commission File Number: 001-39307

Legend Biotech Corporation
(Translation of registrant's name into English)

2101 Cottontail Lane
Somerset, New Jersey 08873
(Address of principal executive office)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F [ X ]      Form 40-F [   ]

Legend Biotech Highlights New CARVYKTI^® Data in Multiple Myeloma and First-in-Human Results from Novel CAR-T Platform in Non-Hodgkin Lymphoma

On December 6, 2025, Legend Biotech Corporation (“Legend Biotech” or the “Company”) issued a press release announcing new data presented at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, FL. New results from the CARTITUDE 1 and CARTITUDE-4 studies showed that a single infusion of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) provided long-term progression free survival benefit in patients with standard-risk relapsed/refractory multiple myeloma. Additionally, new results from the CARTITUDE-4 study showed that earlier use of CARVYKTI® is associated with better immune fitness and stronger immune effects.

In addition to the CARVYKTI data, early results from the ongoing Phase 1 study of LUCAR-G39D demonstrated a manageable safety profile and encouraging antitumor activity in adults with relapsed or refractory B-cell non-Hodgkin lymphoma.

The press release is attached to this Form 6-K as Exhibit 99.1.

This report on Form 6-K is hereby incorporated herein by reference in the registration statements of Legend Biotech on Form F-3 (Nos. 333-278050, 333-272222 and 333-257625) and Form S-8 (No. 333-239478 and 333-283217), to the extent not superseded by documents or reports subsequently filed.

EXHIBIT INDEX

Exhibit		Title
99.1		Press Release dated December 6, 2025

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

		Legend Biotech Corporation
		(Registrant)
Date: December 8, 2025		/s/ Ying Huang
		Ying Huang, Ph.D.
		Chief Executive Officer

FAQ

What did Legend Biotech (LEGN) report in this Form 6-K?

Legend Biotech reported new clinical data on its CAR-T therapies, including CARVYKTI in multiple myeloma and LUCAR-G39D in B-cell non-Hodgkin lymphoma, presented at the 67th ASH Annual Meeting.

What new CARVYKTI data did Legend Biotech highlight for multiple myeloma?

Legend Biotech stated that in the CARTITUDE-1 and CARTITUDE-4 studies, a single infusion of CARVYKTI (ciltacabtagene autoleucel) provided long-term progression free survival benefit in patients with standard-risk relapsed or refractory multiple myeloma.

What did the CARTITUDE-4 study show about earlier use of CARVYKTI?

According to the company, CARTITUDE-4 results showed that earlier use of CARVYKTI was associated with better immune fitness and stronger immune effects in multiple myeloma patients.

What is LUCAR-G39D and what results were reported?

LUCAR-G39D is a novel CAR-T therapy being tested in an ongoing Phase 1 study. Early results in adults with relapsed or refractory B-cell non-Hodgkin lymphoma showed a manageable safety profile and encouraging antitumor activity.

Where were Legend Biotech’s new CAR-T data presented?

The new data for CARVYKTI and LUCAR-G39D were presented at the 67th American Society of Hematology (ASH) Annual Meeting in Orlando, Florida.

How is this 6-K linked to Legend Biotech’s registration statements?

Legend Biotech states that this report on Form 6-K is incorporated by reference into its registration statements on Form F-3 (Nos. 333-278050, 333-272222 and 333-257625) and Form S-8 (Nos. 333-239478 and 333-283217), to the extent not superseded by later filings.