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Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global clinical-stage biotechnology company that develops and manufactures novel therapies, today announced that 12 company-sponsored studies have been accepted for presentation at the 63rd annual edition of the American Society of Hematology (ASH). Meeting and Exhibition. These include two oral presentations and 10 poster presentations.

Highlights of the presentation include updates from the CARTITUDE clinical development program for T-cell therapy (CAR-T) of the experimental B-cell maturation antigen chimeric receptor (BCMA), ciltacabtagene autoleucel ( cilta-cel), for the treatment of patients with relapsed or refractory multiple myeloma (MMRR). Presentations will detail longer-term follow-up data and new subgroup analysis results from the Phase 1b / 2 CARTITUDE-1 study as well as an adjusted indirect comparison of CARTITUDE-1 patient outcomes versus to standard real-time care therapies. global clinical practice of the LocoMMotion study. The first publication of data from cohort B and longer-term follow-up data from cohort A from the CARTITUDE-2 study in previous treatment lines will be presented.

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

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

A selected list of meeting summaries is available below.

ASH Presentations (December 11-14, 2021)

Abstract no.

Title

INFO

Abstract # 549
Oral

Updated Results of CARTITUDE-1: A Phase 1b / 2 Study of Ciltacabtagene Autoleucel, a Chimeric Antigen Receptor T cell therapy directed by B cell maturation antigen, in patients with relapsed multiple myeloma / refractory

Session title: 704. Cellular immunotherapies: cell therapies for myeloma

Date / Time: Sunday, December 12, 2021 from 4:30 p.m. to 6:00 p.m. EST

Presentation time: 5:00 p.m. 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 Compared to Actual Clinical Practice Therapies from the LocoMMotion Prospective Study

Session title: 704. Cellular immunotherapies: cell therapies for myeloma

Date / Time: Sunday, December 12, 2021 4:30 p.m. – 6:00 p.m. EST

Presentation time: 5:15 p.m. EST

Location: Georgia World Congress Center, Hall C2-C3

Abstract # 3938

Attach

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

Session title: 731. Autologous transplantation: clinical and epidemiological: poster III

Date / Time: Monday, December 13, 2021 from 6:00 p.m. to 8:00 p.m. EST

Location: Georgia World Congress Center, Hall B5

Abstract # 2812

Attach

Anakinra targeting cytokine release syndrome associated with chimeric antigen receptor T cell therapies

Session title: 704. Cellular immunotherapies: clinic: poster II

Date / Time: Sunday, December 12, 2021 from 6:00 p.m. to 8:00 p.m. EST

Location: Georgia World Congress Center, Hall B5

Abstract # 3866

Attach

Efficacy and Safety of Ciltacabtagene Autoleucel (Cilta-cel), an antigen-directed chimeric B-cell maturation antigen receptor T cell therapy, in lenalidomide refractory patients with progressive multiple myeloma after 1 to 3 lines previous processing: update

CARTITUDE-2 results

Session title: 704. Cellular immunotherapies: Clinical: Poster III

Date / Time: Monday, December 13, 2021 from 6:00 p.m. to 8:00 p.m. EST

Location: Georgia World Congress Center, Hall B5

Abstract # 2910

Attach

CARTITUDE-2: Efficacy and Safety of Treatment with Ciltacabtagene Autoleucel (Cilta-cel), a B-Cell Processing Antigen (BCMA) Directed by Chimeric Antigen Receptor T cells (CAR T), in patients with myeloma multiple and early relapse after initial treatment

Session title: 731. Autologous transplantation: clinical and epidemiological: poster II

Date / Time: Sunday, December 12, 2021 from 6:00 p.m. to 8:00 p.m. EST

Location: Georgia World Congress Center, Hall B5

Abstract # 1835

Attach

Bortezomib, lenalidomide and dexamethasone (VRd) followed by ciltacabtagene autoleucel vs VRd followed by lenalidomide and dexamethasone (Rd) as maintenance therapy in patients with newly diagnosed multiple myeloma not intended for transplantation: randomized phase 3 study (CARTITUDE- 5)

Session title: 731. Autologous transplantation: clinical and epidemiological: poster I

Date / Time: Saturday, December 11, 2021 5:30 p.m. to 7:30 p.m. EST

Location: Georgia World Congress Center, Hall B5

Abstract # 3057

Attach

LocoMMotion: A prospective, non-interventional, multinational study of current standards of care in real life in patients with relapsed / refractory multiple myeloma who received ≥ 3 prior lines of treatment

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

Date / Time: Sunday, December 12, 2021 from 6:00 p.m. to 8:00 p.m. EST

Location: Georgia World Congress Center, Hall B5

Abstract # 1676

Attach

Meta-analysis of Ciltacabtagene Autoleucel versus physician choice in the treatment of patients with relapsed or refractory multiple myeloma

Session title: 653. Plasma cell myeloma and dyscrasias: clinical and prospective therapeutic trials: poster I

Date / Time: Saturday December 11, 2021 5:30 p.m. – 7:30 p.m.

Location: Georgia World Congress Center, Hall B5

Abstract # 4075

Attach

Concrete results of standard treatments in patients with relapsed / refractory multiple myeloma

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

Date / Time: Monday, December 13, 2021 from 6:00 p.m. to 8:00 p.m. EST

Location: Georgia World Congress Center, Hall B5

Abstract # 1932

Attach

Considerations for Optimal Delivery of Chimeric Antigen Receptor (CAR) T-Cell Therapy Programs: A Multiparty Qualitative Analysis

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

Date / Time: Saturday December 11, 2021 5:30 p.m. – 7:30 p.m.

Location: Georgia World Congress Center, Hall B5

Abstract # 1700

Attach

Tri-specific CD19xCD20xCD22 VHH CAR-T cells (LCAR-AIO) eradicate antigen-heterogeneous B cell tumors, improve 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 p.m. to 7:30 p.m.

Location: Georgia World Congress Center, Hall B5

About CARTITUDE-1

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


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