Legend Biotech (LEGN) Showcases Updated and New Data from Comprehensive BCMA CAR-T, Cilta-Cel, Program and First Preclinical Results for Tri-specific CAR-T at 2021 ASH

November 4, 2021 8:34 AM EDT

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Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, today announced that 12 company-sponsored studies were accepted for presentation at the 63rd American Society of Hematology (ASH) Annual Meeting and Exposition. These include two oral presentations and 10 poster presentations.

Presentation highlights include updates from the CARTITUDE clinical development program for the investigational B-cell maturation antigen (BCMA) directed chimeric antigen receptor T cell (CAR-T) therapy, ciltacabtagene autoleucel (cilta-cel), for the treatment of patients with relapsed or refractory multiple myeloma (RRMM). Presentations will detail longer-term follow-up data and new sub-group analysis results from the Phase 1b/2 CARTITUDE-1 study as well as adjusted indirect comparison of CARTITUDE-1 patient outcomes relative to standard-of-care therapies in real-world clinical practice from the LocoMMotion study. First data release from Cohort B and longer-term follow-up data from Cohort A of the CARTITUDE-2 study in earlier lines of treatments will be presented.

Additionally, Legend will share the first preclinical in vivo data on its novel tri-specific single-domain antibody (VHH) CAR-T (LCAR-AIO). LCAR-AIO targets three antigens—CD19, CD20 and CD22—with the potential for development as a treatment for patients with relapsed B cell lymphoma and prior CD19 CAR-T therapies.

“The new and updated data from the CARTITUDE-1 and CARTITUDE-2 studies show that cilta-cel continues to provide early, deep and durable responses, even in high-risk patients,” said Ying Huang, PhD, CEO and CFO of Legend Biotech. “What’s also encouraging is the new preclinical data from our novel tri-specific VHH CAR-T, which was designed and developed by Legend. This trispecific CAR-T exemplifies our team’s ability to discover novel mechanisms of action by screening and optimizing antibodies in house.”

A select list of abstracts from the meeting can be found below.

ASH Presentations (December 11-14, 2021)

Abstract No.

Title

INFO

Abstract #549
Oral

Updated Results From CARTITUDE-1: Phase 1b/2 Study of Ciltacabtagene Autoleucel, a B-cell Maturation Antigen–Directed Chimeric Antigen Receptor T Cell Therapy, in Patients with Relapsed/Refractory Multiple Myeloma

Session Title: 704. Cellular Immunotherapies: Cellular Therapies for Myeloma

Date/Time: Sunday, December 12, 2021 4:30 PM – 6:00 PM EST

Presentation time: 5:00 PM EST

Room: Georgia World Congress Center, Hall C2-C3

Abstract #550

Oral

Ciltacabtagene Autoleucel for Triple-Class Exposed Multiple Myeloma: Adjusted Comparisons of CARTITUDE-1 Patient Outcomes Versus Therapies from Real-World Clinical Practice from the LocoMMotion Prospective Study

Session Title: 704. Cellular Immunotherapies: Cellular Therapies for Myeloma

Date/Time: Sunday, December 12, 2021 4:30 PM - 6:00 PM EST

Presentation time: 5:15 PM EST

Location: Georgia World Congress Center, Hall C2-C3

Abstract#3938

Poster

Efficacy and Safety of Ciltacabtagene Autoleucel in Patients with Relapsed/Refractory Multiple Myeloma: CARTITUDE-1 Subgroup Analysis

Session Title: 731. Autologous Transplantation: Clinical and Epidemiological: Poster III

Date/Time: Monday, December 13, 2021 6:00 PM - 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #2812

Poster

Anakinra Targeting Cytokine Release Syndrome Associated with Chimeric Antigen Receptor T-cell Therapies

Session Title: 704. Cellular Immunotherapies: Clinical: Poster II

Date/Time: Sunday, December 12, 2021 6:00 PM - 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #3866

Poster


Efficacy and Safety of Ciltacabtagene Autoleucel (Cilta-cel), a B-cell Maturation Antigen–Directed Chimeric Antigen Receptor T-cell Therapy, in Lenalidomide-Refractory Patients with Progressive Multiple Myeloma After 1–3 Prior Lines of Therapy: Updated

Results From CARTITUDE-2

Session Title: 704. Cellular Immunotherapies: Clinical: Poster III

Date/Time: Monday, December 13, 2021 6:00 PM - 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #2910

Poster

CARTITUDE-2: Efficacy and Safety of Ciltacabtagene Autoleucel (Cilta-cel), a B-cell Maturation Antigen (BCMA)-Directed Chimeric Antigen Receptor T Cell (CAR T) Therapy, in Patients with Multiple Myeloma and Early Relapse After Initial Therapy

Session Title: 731. Autologous Transplantation: Clinical and Epidemiological: Poster II

Date/Time: Sunday, December 12, 2021 6:00 PM - 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #1835

Poster


Bortezomib, Lenalidomide, and Dexamethasone (VRd) Followed by Ciltacabtagene Autoleucel vs VRd Followed by Lenalidomide and Dexamethasone (Rd) Maintenance in Patients with Newly Diagnosed Multiple Myeloma Not Intended for Transplant: A Randomized, Phase 3 Study (CARTITUDE-5)

Session Title: 731. Autologous Transplantation: Clinical and Epidemiological: Poster I

Date/Time: Saturday, December 11, 2021 5:30 PM - 7:30 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #3057

Poster

LocoMMotion: A Prospective, Non-interventional, Multinational Study of Real-life Current Standards of Care in Patients with Relapsed/Refractory Multiple Myeloma Who Received ≥3 Prior Lines of Therapy

Session Title: 905. Outcomes Research—Lymphoid Malignancies: Poster II

Date/Time: Sunday, December 12, 2021 6:00 PM - 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #1676

Poster

Meta-analysis of Ciltacabtagene Autoleucel versus Physician’s Choice in the Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Session Title: 653. Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I

Date/Time: Saturday, December 11, 2021 5:30 PM - 7:30 PM

Location: Georgia World Congress Center, Hall B5

Abstract #4075

Poster

Real-World Outcomes for Standard-Of-Care Treatments in Patients with Relapsed/Refractory Multiple Myeloma

Session Title: 905. Outcomes Research—Lymphoid Malignancies: Poster III

Date/Time: Monday, December 13, 2021 6:00 PM - 8:00 PM EST

Location: Georgia World Congress Center, Hall B5

Abstract #1932

Poster

Considerations for optimal administration of Chimeric Antigen Receptor (CAR) T-Cell therapy programs: a multi-stakeholder qualitative analysis

Session Title: 902. Health Services Research—Lymphoid Malignancies: Poster I

Date/Time: Saturday, December 11, 2021 5:30 PM - 7:30 PM

Location: Georgia World Congress Center, Hall B5

Abstract #1700

Poster

Tri-specific CD19xCD20xCD22 VHH CAR-T cells (LCAR-AIO) eradicate antigen-heterogeneous B cell tumors, enhance expansion, and prolong persistence in preclinical in vivo models

Session Title: 703. Cellular Immunotherapies: Basic and Translational: Poster I

Date: Saturday, December 11, 2021 5:30-7:30 PM

Location: Georgia World Congress Center, Hall B5

About CARTITUDE-1

CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, multicenter study evaluating the safety and efficacy of cilta-cel in adults with relapsed or refractory with multiple myeloma, who previously received a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 antibody, and who had disease progression on or after the last regimen.1 The primary objective of the Phase 1b portion of the study was to characterize the safety and confirm the recommended Phase 2 dose of cilta-cel, informed by the first-in-human study with LCAR-B38M CAR-T cells (LEGEND-2). The Phase 2 portion further evaluated the efficacy of cilta-cel with overall response rate as the primary endpoint. Of the 97 patients enrolled in the trial, 99 percent were refractory to the last line of treatment and 88 percent were triple-class refractory, meaning their cancer did not respond, or no longer responds, to an IMiD, a PI and an anti-CD38 antibody.



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