Legendary Biotech Presents First-in-Human Study Results of LB2102 for Solid Tumors and Updated Data on CARVYKTI® for Multiple Myeloma at the 2026 ASCO Annual Meeting

• LB2102 demonstrates a manageable safety profile and encouraging clinical activity in patients with heavily pretreated solid tumors
• At higher dose levels, LB2102 shows a 28.6% objective response rate (ORR) and a 78.6% disease control rate (DCR), with durable responses observed in some patients
• Updated CARVYKTI^® data further support its durable efficacy and consistent safety profile in multiple myeloma

Bridgewater, New Jersey, USAJune 1, 2026 /PRNewswire/ — Legend Biotech Corporation (NASDAQ: LEGN), a global leader in cell therapy, today announced data from the first-in-human trial of its investigational DLL3-targeted CAR-T cell therapy, LB2102, in patients with relapsed or refractory small cell lung cancer (SCLC) or large cell neuroendocrine carcinoma (LCNEC). The data show that LB2102 has demonstrated preliminary clinical activity and a manageable safety profile. At higher dose levels, the study observed a 28.6% objective response rate (ORR) and a 78.6% disease control rate (DCR), with durable responses observed in some heavily pretreated patients.

The data were presented as a rapid oral abstract (Abstract #8012) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, further supporting the clinical potential of CAR-T cell therapy in solid tumors.

Additionally, updated analyses from the CARTITUDE program were presented during the meeting, further highlighting the durable clinical benefit and consistent safety profile of CARVYKTI^® (cilta-cel) in the treatment of multiple myeloma.

Dr. Ying Huang, CEO of Legend Biotech, stated: “The data presented at ASCO reflect progress in our next-generation R&D pipeline and further underscore the sustained clinical value CARVYKTI brings to patients. LB2102 represents our early exploration of expanding CAR-T cell therapy into solid tumors, addressing the challenges posed by limited current treatment options. Early data show encouraging clinical activity in refractory tumors. Meanwhile, CARVYKTI continues to demonstrate durable efficacy and a consistent safety profile, further reinforcing its position as a transformative therapy for multiple myeloma and supporting our leadership in cell therapy.”

LB2102: Preliminary Clinical Activity Observed in Solid Tumors

Early results from the ongoing Phase 1 study of LB2102 show encouraging anti-tumor activity and a manageable safety profile in patients with relapsed or refractory (R/R) SCLC or LCNEC. These patients are typically in advanced stages of disease progression with limited treatment options.

LB2102 is an investigational autologous CAR-T cell therapy targeting DLL3, engineered with a dominant-negative TGF-beta receptor II (dnTGFBR2) armoring domain designed to overcome immunosuppressive signals in the tumor microenvironment, thereby enhancing its anti-tumor activity.

Efficacy Results

• Objective Response Rate (ORR): 20% (4/20)
• Disease Control Rate (DCR): 70% (14/20)
• At ≥ Dose Level 3:
  • ORR: 28.6%
  • DCR: 78.6%
  • Median Duration of Disease Control: 6.1 months
• Median Duration of Response: 6.5 months
• As of the data cutoff, 2 patients remain in ongoing response

Safety Results

• No dose-limiting toxicities (DLTs) or treatment-related deaths were observed
• Cytokine release syndrome (CRS) occurred in 30% of patients, all Grade ≤2
• Immune effector cell-associated neurotoxicity syndrome (ICANS) occurred in 15% of patients, including 2 cases of Grade 1 and 1 case of Grade 3
• Most Grade ≥3 adverse events were hematologic and considered related to lymphodepleting chemotherapy

Zhonglin Hao (M.D., Ph.D.), Professor of Medicine and Cancer Biology and Director of the Thoracic Oncology Program at the University of Kentucky Markey Cancer Center^‡, stated: “Patients with relapsed or refractory SCLC and LCNEC have long faced limited treatment options and poor prognoses. LB2102 showing durable disease control and responses at higher dose levels, with a generally manageable safety profile, is encouraging. These results support further exploration of CAR-T therapy in solid tumors, particularly in areas where effective treatments remain limited.”

LB2102 is a key part of the company’s strategy to advance CAR-T therapy from hematologic malignancies to solid tumors. In November 2023, Legend Biotech Ireland Limited, a subsidiary of Legend Biotech, entered into a licensing agreement with Novartis Pharma AG (the “Novartis Agreement”), granting Novartis an exclusive license to develop, manufacture, and commercialize specific DLL3-targeted CAR-T cell therapies globally.

Under the Novartis Agreement, Legend Biotech is responsible for conducting the Phase 1 clinical trial of LB2102 in the United States, while Novartis is responsible for all other development, manufacturing, and commercialization activities for the licensed products, including LB2102.

CARVYKTI^®: Updated Clinical Data in Multiple Myeloma

Updated analyses from the CARTITUDE program further demonstrate durable efficacy and a consistent safety profile for CARVYKTI^® in patients with multiple myeloma.

In a subgroup analysis of CARTITUDE-4 (Abstract #7536), both high-risk and standard-risk cytogenetic subgroups showed progression-free survival (PFS) and overall survival (OS) benefits in patients who responded to bridging therapy, with 30-month OS rates exceeding 85% in both groups. No cases of immune effector cell (IEC)-associated Parkinsonism were reported.

In another pooled analysis across multiple studies (Abstract #7533), the incidence of immune effector cell-associated enterocolitis (IEC-EC) was low (1.2%), further deepening understanding of this rare adverse event and supporting the overall favorable benefit-risk profile of CARVYKTI^®.

CARVYKTI^® is the first and currently only BCMA-targeted CAR-T cell therapy approved for the treatment of patients with multiple myeloma who have received at least one prior line of therapy. To date, CARVYKTI^® has been commercialized in 18 countries and regions worldwide, with over 10,000 patients treated.

About CARVYKTI^® (cilta-cel)

Cilta-cel is a chimeric antigen receptor T-cell (CAR-T) therapy targeting B-cell maturation antigen (BCMA). It uses a transgene encoding a chimeric antigen receptor (CAR) to modify a patient’s own T cells to recognize and eliminate cells expressing BCMA. The CAR protein in cilta-cel features two BCMA-targeting single-domain antibodies, conferring high affinity for BCMA-expressing cells. Upon binding to BCMA-expressing cells, the CAR promotes T cell activation, expansion, and subsequent target cell clearance.^[1]

In December 2017, Legend Biotech entered into a global exclusive license and collaboration agreement with Janssen, a Johnson & Johnson company, to jointly develop and commercialize cilta-cel. In February 2022, cilta-cel received U.S. Food and Drug Administration (FDA) approval for the treatment of adult patients with relapsed or refractory multiple myeloma, under the brand name CARVYKTI^®. In April 2024, the indication for cilta-cel was expanded to include second-line treatment of adult patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy, including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD), and are refractory to lenalidomide.

In May 2022, the European Commission granted conditional marketing authorization for CARVYKTI^® for the treatment of adult patients with relapsed or refractory multiple myeloma; it was approved by Japan’s Ministry of Health, Labour and Welfare in September of the same year. The product received Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020, and was granted Priority Medicines (PRIME) eligibility by the European Commission in April 2019. The U.S. FDA, European EMA, and Japan’s PMDA granted orphan drug designation for cilta-cel in February 2019, February 2020, and June 2020, respectively. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products unanimously recommended maintaining the orphan drug designation for cilta-cel based on clinical data showing improved and sustained complete response rates.

About Multiple Myeloma

Multiple myeloma is considered an incurable hematologic malignancy characterized by the overgrowth of plasma cells in the bone marrow.^[2] It is estimated that over 35,000 people will be diagnosed with multiple myeloma in the U.S. in 2024, and more than 12,000 will die from the disease.^[3] While some patients with multiple myeloma are initially asymptomatic, the majority are diagnosed due to symptoms related to the disease, which may include bone disease, decreased blood cell counts, elevated calcium levels, kidney disease, or infection.^[4]

About CARTITUDE-4

About LB2102

About Small Cell Lung Cancer

Lung cancer is one of the leading causes of cancer death, accounting for approximately 25% of all cancer deaths annually in the U.S.^[7] Small cell lung cancer (SCLC) is the most aggressive form, representing about 10%-15% of lung cancer cases in the U.S.^[8,9] It is estimated that there are approximately 30,000 to 35,000 new cases diagnosed each year. Once the cancer spreads and progresses to extensive-stage SCLC, treatment becomes significantly more challenging. Approximately 60% to 70% of SCLC patients have metastatic disease at the time of diagnosis.^[10]

About Legend Biotech

Legend Biotech is the world’s largest independent cell therapy company, with over 3,000 employees dedicated to developing breakthrough therapies that can transform the cancer treatment landscape. In collaboration with its partner Johnson & Johnson, Legend Biotech developed and commercialized CARVYKTI^®, a one-time therapy for the treatment of relapsed or refractory multiple myeloma, leading the revolution in CAR-T cell therapy. Headquartered in the U.S., the company is strengthening its leadership to build an end-to-end cell therapy system, enhancing patient access to CARVYKTI^® and fully realizing its therapeutic potential. Building on this platform, the company aims to drive continued innovation in its cutting-edge cell therapy pipeline.

For more information, please visithttps://legendbiotech.com and follow us on X and LinkedIn.

Forward-Looking Statements

This press release contains statements regarding future expectations, plans, and prospects, as well as any other statements that are not historical facts, which 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 related to Legend Biotech’s strategies and objectives; statements related to the benefits of CARVYKTI^® (including its emerging curative potential); and statements related to the potential of LB2102 (including the reproducibility and durability of any favorable results initially observed in patients dosed in clinical trials to date). Although not all forward-looking statements contain these identifying words, words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “will,” “would,” and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements due to various important factors. Legend Biotech’s expectations may be affected by, among other things: uncertainties associated with the development of new pharmaceutical products; unexpected clinical trial results, including results from additional analyses of existing clinical data or unexpected new clinical data; unexpected regulatory actions or delays, including requests for additional safety and/or efficacy data or data analyses, or general government regulation; unexpected delays due to actions or inactions by third-party partners; uncertainties arising from challenges to Legend Biotech’s patent or other proprietary intellectual property protection, including uncertainties involved in U.S. litigation proceedings; government, industry, and general product pricing and other political pressures; and other factors discussed in the “Risk Factors” section of Legend Biotech’s Annual Report on Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) on March 10, 2026. If one or more of these risks or uncertainties materializes, or if underlying assumptions prove incorrect, actual results may differ materially from those described in this press release as anticipated, believed, estimated, or expected. Any forward-looking statements contained in this press release speak only as of the date hereof. Legend Biotech expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events, or otherwise.

^‡ Zhonglin Hao (M.D., Ph.D.), Professor of Medicine and Cancer Biology and Director of the Thoracic Oncology Program at the University of Kentucky Markey Cancer Center, has provided consulting and advisory services to Legend Biotech and has not received compensation for any media work.

This press release is a Chinese translation. In case of any inconsistency between the Chinese and English versions, the original English version published on the company’s website shall prevail.