On November 6, 2019 Legend Biotech reported data from the Janssen Research & Development, LLC (Janssen) CARTITUDE-1 study (US) and the LEGEND-2 study (China) will be presented during the 61stAmerican Society of Hematology (ASH) (Free ASH Whitepaper) Annual meeting in Orlando, Florida taking place December 7-10, 2019 (Press release, Legend Biotech, NOV 6, 2019, View Source [SID1234550607]).

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"The data presentations at ASH (Free ASH Whitepaper) 2019 represent two key milestones; the initial data from CARTITUDE-1 study in the US and the long term follow-up for the LEGEND-2 study in China," stated Yuan Xu, PhD, CEO of Legend Biotech. "In collaboration with Janssen, we are committed to the clinical development of LCAR-B38M/JNJ-4528 and are working diligently together to bring this investigational therapy to patients with multiple myeloma."

On Monday, December 9th during the Myeloma session titled: Therapy, excluding Transplantation: Novelty in CAR-T in RRMM, the first clinical data from the CARTITUDE-1 study will be presented. In the same session, long-term follow-up data from the previously reported LEGEND-2 study in China for the 57 patients enrolled at the Second Affiliated Hospital of Xi’an Jiaotong University will be presented, with updated data.

Additionally, updated results for the 17 patients enrolled in the LEGEND-2 study at the Shanghai Ruijin Hospital, Shanghai Changzheng Hospital, and Jiangsu Province People’s Hospital will be presented by the investigators.

Abstracts will be presented during the following dates and times:

Abstract#/Title Presenting Author Date and Time ABSTRACT #577: Results from CARTITUDE-1: a Phase 1b/2 study of JNJ-4528, a CAR-T cell therapy directed against BCMA, in patients with RRMM D Madduri Oral Presentation Monday, December 9, 7:00 am Hall D ABSTRACT #579: Long-term follow-up of a Phase 1, first-in-human open-label study of LCAR-B38M, a structurally differentiated CAR-T cell therapy targeting BCMA, in patients with RRMM BY Wang Oral Presentation Monday, December 9, 7:30 am Hall D ABSTRACT #928: Translational analysis from CARTITUDE-1, an ongoing Phase 1b/2 study of JNJ-4528 BCMA-targeted CAR-T cell therapy in RRMM, indicates preferential expansion of CD8+ T Cell central memory cell subset E Zudaire Oral Presentation Monday, December 9, 7:00 pm Valencia A (W415A) ABSTRACT #1858: Updated Phase 1 results of a first-in-human open-label study of LCAR-B38M, a structurally differentiated CAR-T cell therapy targeting BCMA LJ Chen Poster Presentation Saturday, December 7, 5:30 pm Hall B In February 2019, the US Food and Drug Administration granted Janssen an Orphan Drug Designationfor JNJ-4528. On April 3, 2019, Legend announced that the European Medicines Agency (EMA) granted Janssen a PRIME1 designationfor JNJ-4528, which was supported by results from the Phase 1b/2

CARTITUDE-1 study (NCT03548207) 2 and the Phase 1/2 LEGEND-2 study (NCT03090659)3 evaluating LCAR-B38M in RRMM. About LEGEND-2 LEGEND-2 (NCT03090659) is an ongoing single-arm, open-label Phase 1/2 study of 74 patients being conducted at four participating hospitals in China evaluating the efficacy and safety of LCAR-B38M for the treatment of relapsed or refractory multiple myeloma.

About CARTIFAN-1
In China, the Phase 2 CARTIFAN-1 (MMY2002, NCT03758417)4 confirmatory trial registered with the Center for Drug Evaluation (CTR20181007), is actively recruiting to further evaluate LCARB38M in patients with advanced relapsed or refractory multiple myeloma. About CARTITUDE-1 In the US, JNJ-4528 is currently being investigated in the Phase 1b/2 CARTITUDE-1 (MMY2001, NCT03548207) registration study for the treatment of patients with multiple myeloma who have received at least 3 prior lines of therapy or are double refractory to a PI and IMiD, received a PI, an IMiD, and anti-CD38 antibody and documented disease progression within 12 months of starting the most recent therapy. About CARTITUDE-2 In the global, multi-cohort Phase 2

CARTITUDE-2 (MMY2003, NCT04133636) 5 study, JNJ-4528 will be investigated in patients with multiple in various clinical settings. This study is being conducted to evaluate the overall minimal residual disease (MRD) negative rate of participantswho receive JNJ-4528.

About LocoMMotion
In the US and EU, a prospective observational study LocoMMotion (MMY4001, NCT04035226) 6 is being conducted to evaluate current real-world standards of care in patients with RRMM who received at least 3 prior lines of therapy including a PI, an IMiD, and anti-CD38 antibody. The abstract will be published in Blood.

About Multiple Myeloma

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells. 7 Although treatment may result in remission, unfortunately, patients will most likely relapse. 8 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy. 9,10 Relapsed myeloma is when the disease has returned after a period of initial, partial or complete remission and does not meet the definition of being refractory. 11 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.12 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.13