Washington, D.C. 20549
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
Date of Report: April 21, 2023
Commission File Number: 001-39307
Legend Biotech Corporation
(Exact Name of Registrant as Specified in its Charter)

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  ☒            Form 40-F  ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

Legend Biotech Announces Disclosure of Clinical Study Abstracts by The European Hematology Association

On April 21, 2023, Legend Biotech Corporation (“Legend Biotech” or the “Company”) announced that the following clinical study abstracts were publicly disclosed by The European Hematology Association (“EHA”) on the evening of April 18, 2023 (Eastern time):

“First Phase 3 Results From CARTITUDE-4: Cilta-cel versus standard of care (PVd or DPd) in lenalidomide-refractory multiple myeloma”
“CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma”
“Long-term remission and survival in patients with relapsed or refractory multiple myeloma after treatment of LCAR-B38M CAR-T – at least 5-year follow-up in LEGEND-2”

Such public disclosures by EHA were not authorized by the Company. The abstracts are attached to this Form 6-K as Exhibits 99.1, 99.2 and 99.3, respectively.

This report on Form 6-K is hereby incorporated by reference into the Company’s Registration Statements on Form F-3 (Registration Nos. 333-257625 and 333-257609) and the Company’s Registration Statement on Form S-8 (Registration No. 333-239478).

Cautionary Note Regarding Forward-Looking Statements

Statements in this report on Form 6-K about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to CARVYKTI® (ciltacabtagene autoleucel) and expected results of clinical trials involving CARVYKTI. The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Legend Biotech’s expectations could be affected by, among other things, uncertainties involved in the development of new pharmaceutical products; unexpected clinical trial results, including as a result of additional analysis of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or analysis of data, or government regulation generally; unexpected delays as a result of actions undertaken, or failures to act, by our third party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including the uncertainties involved in the U.S. litigation process; competition in general; government, industry, and general product pricing and other political pressures; the duration and severity of the COVID-19 pandemic and governmental and regulatory measures implemented in response to the evolving situation; as well as the other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 30, 2023. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those described in this report on Form 6-K as anticipated, believed, estimated or expected. Any forward-looking statements contained in this report on Form 6-K speak only as of the date of this report on Form 6-K. Legend Biotech specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.


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.
Date: April 21, 2023
/s/ Ying Huang
Ying Huang, Ph.D.
Chief Executive Officer

Exhibit 99.1

CARTITUDE-4 is a global, phase 3, randomized, controlled trial (NCT04181827) of ciltacabtagene autoleucel (cilta-cel), a dual-binding, B-cell maturation antigen-targeting chimeric antigen receptor (CAR)-T cell therapy, versus (vs) standard of care (SOC; pomalidomide, bortezomib, and dexamethasone [PVd] or daratumumab, pomalidomide, and dexamethasone [DPd]) in lenalidomide-refractory patients.

To report results of the first phase 3 study evaluating efficacy and safety of cilta-cel vs SOC in lenalidomide-refractory patients treated with 1-3 prior lines of therapy (LOT).

Eligible patients had 1–3 prior LOT, including proteasome inhibitors (PI) and immunomodulatory drugs, and were lenalidomide-refractory. After apheresis, patients randomized to cilta-cel received PVd or DPd (physician’s choice) bridging therapy, then 1 cilta-cel infusion (target dose 0.75×106 CAR+ viable T cells/kg) 5–7 days after lymphodepletion. In the SOC group, patients received PVd or DPd (physician’s choice) until disease progression. The primary endpoint was progression-free survival (PFS), analyzed in the intent-to-treat (randomized) population. Informed consent was obtained prior to study entry.

419 patients were randomized (cilta-cel, n=208; SOC, n=211 [PVd, n=28; DPd, n=183]). 176 patients received planned cilta-cel treatment, 20 more received cilta-cel after progressive disease (PD) during bridging therapy, and 208 received SOC treatment. There were no manufacturing failures. Baseline characteristics were balanced (cilta-cel vs SOC: 59% vs 63% cytogenetic high risk [including gain/amp 1q]; 50% vs 46% PI refractory; 24% vs 22% anti-CD38 refractory; 33% vs 32% had 1 prior LOT). Median dose of cilta-cel was 0.71×106 CAR+ viable T cells/kg. At Nov 1, 2022, data cut-off, median follow-up was 16 months (range, 0.1–27). The primary endpoint was met; cilta-cel reduced risk of progression/death by 74% (Hazard ratio [HR]=0.26; P-value [P] <0.0001). Patients in the cilta-cel group had significantly improved overall response rate, rate of complete response (CR) or better, and overall minimal residual disease (MRD) negativity rate compared to the SOC group (Table), with a positive trend in overall survival (HR, 0.78; 95% CI, 0.5–1.2). 97% and 94% of patients treated in the cilta-cel and SOC groups, respectively, had grade 3/4 adverse events, including infections (27% vs 25%) and cytopenias (94% vs 86%). In the cilta-cel and SOC groups, respectively, 39 and 46 patients died (14 and 30 due to PD). In patients who received cilta-cel as study treatment (n=176), 76% had cytokine release syndrome (1% grade 3; no grade 4/5) and 5% had immune effector cell associated neurotoxicity syndrome (all grade 1/2). A single case of movement and neurocognitive treatment-emergent adverse event was reported (grade 1).


A single cilta-cel infusion significantly improved PFS vs SOC in lenalidomide-refractory patients with 1–3 prior LOT, with a favorable benefit/risk profile across patient populations. The 74% reduction in progression/death and high rates of CR and MRD-negativity highlight the potential for cilta-cel to become a key therapy for patients with multiple myeloma after first relapse.

   Copyright © 2023.  All rights reserved.


Exhibit 99.2

Heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM) treated with standard of care therapy have median overall survival (OS) of ~12 months. In the single- arm, phase 1b/2 CARTITUDE-1 study (NCT03548207), patients received a single infusion of ciltacabtagene autoleucel (cilta-cel), a chimeric antigen receptor-T cell therapy targeting B- cell maturation antigen. At the final protocol-specified analysis (27.7-month median follow- up), overall response rate (ORR) was 98%, with 83% stringent complete response; 27- month rates of progression-free survival (PFS) and OS were 55% and 70%, respectively.

To report CARTITUDE-1 study close out efficacy and safety results.

Informed consent was obtained prior to study entry. Enrolled patients had received ≥3 prior lines of therapy (LOT) or were double refractory to a proteasome inhibitor (PI) and immunomodulatory drug (IMiD); and had received prior PI, IMiD, and anti-CD38 antibody therapy. Primary endpoint was ORR and safety; secondary endpoints included PFS, OS, and minimal residual disease (MRD)-negativity at 10-5.

97 patients received cilta-cel (59% male; median age 61 years; median of 6 prior LOT; 42% penta-drug refractory; 88% triple-class refractory; 99% refractory to last LOT). As of October 14, 2022, median follow-up was 33.4 months (range, 1.5−45.2). Median duration of response was 33.9 month (95% CI, 25.5–not estimable [NE]). Median PFS was 34.9 months (95% CI, 25.2–NE), with an estimated 47.5% of patients progression free and alive at 36 months. Median OS was not reached, with an estimated 62.9% survival at 36 months. Of 49 MRD-evaluable patients, 26 had MRD-negativity sustained for ≥12 months, of which 20 had sustained MRD-negative complete response (CR) or better. Median PFS was not reached in these subgroups (Table). Eighteen patients were MRD-negative with ≥CR at 24-months post infusion. No new safety signals and no new neurotoxicity events were reported since the 27.7-month median follow-up. Six new cases of second primary malignancy were reported, including 2 cases of basal cell carcinoma and 1 case each of myelodysplastic syndrome, B- cell lymphoma, melanoma, and prostate cancer. Five additional deaths occurred (progressive disease [PD], n=3; pneumonia and sepsis, n=1 each [both unrelated to cilta- cel]), for a total of 35 deaths (PD, n=17; unrelated to cilta-cel, n=12; related, n=6).

Longer median PFS was observed after a single infusion of cilta-cel than any previously reported therapy in heavily pretreated patients with RRMM. Achieving CR and/or sustained MRD-negativity was associated with prolonged PFS. Patients continue to be followed for safety and survival in the 15-year CARTINUE long-term study (NCT05201781; MMY4002).

   Copyright © 2023.  All rights reserved.


Exhibit 99.3

LCAR-B38M CAR-T cells express a structurally differentiated chimeric antigen receptor (CAR) construct containing a 4-1BB costimulatory domain and 2 BCMA-targeting single-domain antibodies designed to confer avidity. LEGEND-2 was a first-in-human phase 1 study of LCAR-B38M conducted in China, which showed encouraging efficacy and manageable safety in 74 patients with relapsed or refractory multiple myeloma (RRMM). The US phase 1b/2 CARTITUDE-1 and Chinese phase 2 CARTIFAN-1 trials of ciltacabtagene autoleucel, which expresses the same CAR as LCAR-B38M, confirmed the efficacy observed in LEGEND-2. Here, we present ≥5-year follow-up data from LEGEND-2, the longest follow-up for any BCMA-targeted CAR-T cell therapy study.

To report the efficacy and safety of LCAR-B38M after at least 5 years of follow-up in LEGEND-2.

Study design was previously published. All patients in the trial provided informed consent. Patients underwent lymphodepletion with cyclophosphamide 300 mg/m2 (n=66) or cyclophosphamide 250 mg/ m2 plus fludarabine 25 mg/m2 (n=8) prior to receiving LCAR-B38M at a median dose of 0.51 × 106 (range, 0.07-2.10 × 106) CAR-positive T cells/kg in a single (n=9) or 3 split (n=65) infusions.

Patients were enrolled from 30 March 2016 to 26 November 2017. As of 30 November 2022, median follow-up was 65.4 months (range, 0.4-78.8). 74 patients had received LCAR-B38M (median age, 54.5 years; 60.8% male; median [range] 3 [1-9] prior lines of therapy [LOT]; 44.6% ISS stage I; 28.4% ISS stage III; 29.7% with extramedullary disease (EMD); 35.7% cytogenetic high risk). No new CAR-T cell-related toxicities were reported in the analysis. Overall response rate (87.8%), complete response (CR) rate (73.0%), minimal residual disease-negative CR rate (67.6%), median duration of response (23 months), and median progression-free survival (18 months) were mature and the same as previously reported; median overall survival (OS) was previously not reached. At 65.4-month median follow-up, median OS was 55.8 months, with 33 (44.6%) patients alive and 13 (17.6%) still disease- free. Compared with patients with progressive disease (PD) or who died, patients without PD were more likely to have baseline ECOG performance status (PS) 0, IgG type MM, ISS stage I MM, numerically shorter time from diagnosis, fewer prior LOT, no light chain MM, and no EMD (Table).


At ≥5-year follow-up in LEGEND-2, median OS was 55.8 months and 18% of patients with RRMM were disease-free, raising the possibility of a cure in this heavily pretreated patient population. Our data suggest that patients who are less heavily pretreated or have good functional status may experience greater benefit, potentially being cured, from LCAR-B38M CAR-T cell therapy.

  Copyright © 2023.  All rights reserved.