On November 4, 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that three abstracts highlighting data and information from three oncology drug candidates in its pipeline will be presented at the upcoming 63rd Annual American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting to be held December 11 – 14, 2021 (Press release, MEI Pharma, NOV 4, 2021, View Source [SID1234594529]).

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Details on the poster presentations are included below:

Title: Coastal: A Phase 3 Study of the PI3Kδ Inhibitor Zandelisib with Rituximab (R) Versus Immunochemotherapy in Patients with Relapsed Indolent Non-Hodgkin’s Lymphoma (iNHL)
Authors: Wojciech Jurczak, M.D., Ph.D., et. al.
Date: Sunday, December 12, 2021, 6:00 PM – 8:00 PM ET
Abstract ID: 2430

Summary of study methods: the COASTAL study is a randomized, open-label, controlled multicenter phase 3 trial to investigate the safety and efficacy of zandelisib in combination with rituximab versus standard immunochemotherapy in patients with relapsed or refractory follicular or marginal zone lymphomas who received at least one prior line of therapy. Eligible patients must have received an anti-CD20 antibody in combination with chemotherapy or lenalidomide.

Title: A Novel Isoflavone, ME-344, Enhances Venetoclax Antileukemic Activity Against AML Via Suppression of Oxidative Phosphorylation and Purine Biosynthesis
Authors: Katie Hurrish, et. al.
Date: Sunday, December 12, 2021, 6:00 PM – 8:00 PM ET
Abstract ID: 2238

Summary of results: preclinical studies evaluating the combination of ME-344 with venetoclax in AML cell lines, including those with cytarabine resistance, and in an AML patient sample, suggest that ME-344 suppresses OXPHOS and the purine biosynthesis pathway to enhance the antileukemic activity of venetoclax against AML.

Title: A Phase 1 Dose-Escalation Study of the Oral CDK Inhibitor Voruciclib in Patients with Relapsed/Refractory B-Cell Malignancies or Acute Myeloid Leukemia (AML): Preliminary Results of the Completed Dose Escalation Stage in AML
Authors: Marina Konopleva, M.D., Ph.D., et. al.
Date: Monday, December 13, 2021, 6:00 PM – 8:00 PM ET
Abstract ID: 3423

Summary of conclusions: voruciclib administered on an optimized schedule of 14 consecutive days in a 28-day cycle was well tolerated. Further, no dose limiting toxicities were observed and no significant myelosuppression was seen in patients with B-cell malignancies, suggesting no overlapping toxicities with venetoclax. Disease stabilization was observed in heavily pretreated patients and differentiation syndrome was observed in AML patients indicating biologic activity. A protocol amendment is forthcoming to evaluate voruciclib in combination with venetoclax in patients with relapsed AML.

The abstracts are available on the ASH (Free ASH Whitepaper) annual meeting website. The e-poster presentations will be available on the MEI Pharma website on the morning each poster opens for viewing at ASH (Free ASH Whitepaper).

On November 4, 2021 Gamida Cell Ltd. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, reported four presentations at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, which is being held in Atlanta, Georgia or virtually from December 11-14, 2021 (Press release, Gamida Cell, NOV 4, 2021, View Source [SID1234594527]).

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New data on omidubicel, a potentially life-saving treatment for patients with blood cancers in need of stem cell transplant, will be presented during an oral presentation showing that hematopoietic stem cell transplantation with omidubicel is associated with robust immune constitution and lower rates of severe infection compared to standard umbilical cord blood transplantation. Additionally, there will be three poster presentations and one e-publication highlighting additional clinical data from omidubicel and GDA-201, the company’s natural killer (NK) cell immunotherapy in development for the treatment of hematologic and solid tumors with standard of care antibody therapies. Together the data that will be presented at ASH (Free ASH Whitepaper) reflect the progress across Gamida Cell’s NAM-enabled pipeline of cell therapies being developed as potentially curative approaches for cancer patients in need of new and better therapeutic options.

Details about the ASH (Free ASH Whitepaper) presentations are as follows:

Title: Hematopoietic Stem Cell Transplantation (HSCT) with Omidubicel Is Associated with Robust Immune Reconstitution and Lower Rates of Severe Infection Compared to Standard Umbilical Cord Blood Transplantation (Oral)
Abstract Number: 333
Lead Author: Paul Szabolcs, M.D., Division of Blood and Marrow Transplantation and Cellular Therapy, UPMC Children’s Hospital of Pittsburgh, Pittsburg, PA
Time: Saturday, December 11, 2021, 4:00 p.m. – 5:30 p.m. EST (session time) and 4:30 p.m. EST (presentation)

Title: Allogeneic Stem Cell Transplantation with Omidubicel: Long-Term Follow-up from a Single Center (Poster)
Abstract Number: 1827
Lead Author: Chenyu Lin, M.D., Department of Medicine, Division of Hematologic Malignancies and Cellular Therapy, Duke University Medical Center, Durham, NC
Time: Saturday, December 11, 2021, 5:30 p.m. – 7:30 p.m. EST

Title: GDA-201, a Novel Metabolically Enhanced Allogeneic Natural Killer (NK) Cell Product Yields High Remission Rates in Patients with Relapsed/Refractory Non-Hodgkin Lymphoma (NHL): 2-Year Survival and Correlation with Cytokine IL7 (Poster)
Abstract Number: 3854
Lead Author: Veronika Bachanova, M.D., Ph.D., Division of Hematology, Oncology and Transplantation, University of Minnesota, Minneapolis, MN
Time: Monday, December 13, 2021, 6:00 p.m. – 8:00 p.m. EST

Title: Hospitalization and Healthcare Resource Use of Omidubicel Vs Cord Blood Transplantation for Hematological Malignancies in a Global Randomized Phase III Clinical Trial (Poster)
Abstract Number: 4036
Lead Author: Navneet Majhail, M.D., Taussig Cancer Institute, Department of Hematology and Oncology, Cleveland Clinic, Cleveland, OH
Time: Monday, December 13, 2021, 6:00 p.m. – 8:00 p.m. EST

Title: Transcriptional and Metabolic Profiling of Nicotinamide-Enhanced Natural Killer (NAM-NK) Cells (GDA-201) (e-Publication)
Abstract Number: 4791
Lead Author: Dima Yackoubov, M.Sc., Gamida Cell, Jerusalem, Israel

About Omidubicel

Omidubicel is an advanced cell therapy under development as a potential life-saving allogeneic hematopoietic stem cell (bone marrow) transplant for patients with hematologic malignancies (blood cancers), for which it has been granted Breakthrough Status by the FDA. Omidubicel is also being evaluated in a Phase 1/2 clinical study in patients with severe aplastic anemia (NCT03173937). The aplastic anemia investigational new drug application is currently filed with the FDA under the brand name CordIn, which is the same investigational development candidate as omidubicel. For more information on clinical trials of omidubicel, please visit www.clinicaltrials.gov.

Omidubicel is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

About GDA-201

Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising initial clinical trial results, as reported at the 2020 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting & Exposition1. GDA-201 addresses key limitations of NK cells by increasing the cytotoxicity and in vivo retention and proliferation in the bone marrow and lymphoid organs. Furthermore, GDA-201 improves antibody-dependent cellular cytotoxicity (ADCC) and tumor targeting of NK cells. For more information about GDA-201, please visit View Source

GDA-201 is an investigational therapy, and its safety and efficacy have not been established by the FDA or any other health authority.

On November 4, 2021Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that updated clinical data from its Phase 1 dose-escalation study of plamotamab, a CD20 x CD3 bispecific antibody, in patients with B-cell malignancies will be presented in a poster session during the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in Atlanta, Georgia on Sunday, December 12, 2021 (Press release, Xencor, NOV 4, 2021, View Source [SID1234594526]).

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"Plamotamab is generally well tolerated and demonstrates encouraging clinical activity at our recommended intravenous Phase 2 dose, 50 mg flat dosing every two weeks after step-up dosing. We believe the best outcomes for patients require our focus on studying unique combinations of plamotamab with chemotherapy-free partners, and we are initiating the first of these studies in patients with relapsed or refractory diffuse large B cell lymphoma in late 2021 or early 2022," said Allen Yang, M.D., Ph.D., senior vice president and chief medical officer at Xencor. "Additionally, our recently announced collaboration for advancing plamotamab development will close soon, and this will expand our strategy to develop multiple highly active chemotherapy-free regimens across B-cell cancers, importantly with tumor-selective, co-stimulatory CD28 bispecific antibodies."

Key Highlights from the Abstract

The accepted abstract with data from the study is available through the ASH (Free ASH Whitepaper) website. Updated results will be shared at the ASH (Free ASH Whitepaper) Annual Meeting.

At data cut off on July 1, 2021, 80 patients with relapsed or refractory non-Hodgkin’s lymphoma (NHL) had received doses of plamotamab. Patients had a median age of 62 years, a median of 4 prior therapies and had been diagnosed a median of 28 months prior to treatment. The study was originally designed in two parts: Part A to establish an initial priming dose with fixed, weight-based dosing regimens and Part B to escalate dosing on administrations subsequent to the priming dose. A third part, Part C, was added to establish a step-up dosing regimen with higher, flat and less frequent, every other week, dosing.

The most common treatment-related adverse event was cytokine release syndrome (CRS), which occurred in 62.5% (50/80) of patients, with 5.0% (4/80) experiencing Grade 3 or 4 events. CRS was generally manageable with premedication. No related neurotoxicity Grade 2 or higher was observed.

The efficacy analysis included 53 evaluable patients who were treated at doses between 80 and 360 mcg/kg (n=45) or at flat doses of 50 mg (n=8). The overall response rate (ORR) was 38.2% (13/34) in patients with diffuse large B-cell lymphoma. The ORR was 80% (8/10) for patients with follicular lymphoma. The median duration of response was 57 days.

After the implementation of higher doses in the flat-dosing regimen, the ORR among all patients with NHL had improved to 50% (4/8) from 42.2% (19/45) in prior weight-based dosing cohorts. At data cut off, the median duration of response was 19.5+ days, with three of four patients continuing to respond to plamotamab monotherapy.

The ORR for patients with prior CAR-T therapy was 25% (4/16).

Presentation Details

Abstract 2494, "Safety and Anti-Tumor Activity of Plamotamab (XmAb13676), an Anti-CD20 x Anti-CD3 Bispecific Antibody, in Subjects with Relapsed/Refractory Non-Hodgkin’s Lymphoma"
Session: 626. Aggressive Lymphomas: Prospective Therapeutic Trials: Poster II
Date & Time: Sunday, December 12, 2021. 6:00 – 8:00 p.m. EST
Location: Georgia World Congress Center, Hall B5
About Plamotamab

Plamotamab is an investigational tumor-targeted XmAb bispecific antibody that contains both a CD20 binding domain and a cytotoxic T-cell binding domain (CD3). CD20 is highly expressed across a range of B-cell tumors, including non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL). Engagement of CD3 by plamotamab activates T cells for highly potent and targeted killing of CD20-expressing tumor cells.

Plamotamab is currently being evaluated in a Phase 1 clinical study for the treatment of patients with CD20-expressing hematologic malignancies, including NHL and CLL. Preliminary safety and anti-tumor activity from the Phase 1 study indicated that plamotamab was generally well tolerated and demonstrated encouraging clinical activity as a monotherapy.

On November 4, 2021 Catamaran Bio, Inc., a biotechnology company developing off-the-shelf CAR-NK cell therapies to treat cancer, reported that it has designated CAT-179, a HER2-targeted CAR-NK cell therapy, and CAT-248, a CD70-targeted CAR-NK cell therapy, as its first preclinical development programs (Press release, Catamaran Bio, NOV 4, 2021, View Source [SID1234594524]). The company also announced that data supporting the CAT-248 program will be presented during a poster session at the 63rd Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) which will be held virtually and in person in Atlanta from December 11-14, 2021.

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At ASH (Free ASH Whitepaper), Catamaran will present data demonstrating the successful deployment of its proprietary TAILWIND platform to generate a CAR-NK cell therapy which demonstrates high levels of cytotoxicity against various tumor cell lines. Catamaran’s TAILWIND platform provides an integrated CAR-NK solution that includes technology to overcome the immunosuppressive tumor microenvironment, CAR architectures optimized for NK cells, and non-viral transposon engineering for efficient manufacturing of CAR-NK cell therapies. The ASH (Free ASH Whitepaper) presentation will focus on preclinical data supporting CAT‑248, Catamaran’s allogeneic CAR-NK cell therapy directed against CD70, a tumor antigen that is highly expressed on certain types of cancers, including renal cell carcinoma, pancreatic cancer, and acute myeloid leukemia. This work is a collaboration between Catamaran and the lab of Dr. Branden Moriarity, scientific co-founder of Catamaran and Associate Professor in the Department of Pediatrics, Division of Hematology/Oncology at the University of Minnesota Medical School.

"The unveiling of our initial two development programs demonstrates Catamaran’s rapid progress toward delivering off-the-shelf CAR‑NK cell therapies capable of reaching solid tumors," said Alvin Shih, MD, Chief Executive Officer of Catamaran Bio. "The new preclinical data we will be presenting at ASH (Free ASH Whitepaper) demonstrate the viability and potential of our TAILWIND platform to enable a leading-edge solution for skillfully designing and efficiently manufacturing CAR-NK cell therapies for the treatment of cancer. We are excited to continue advancing our lead programs toward the clinic, as we seek to extend the transformative potential of cell therapy to patients with solid tumors."

The details of Catamaran’s presentation at ASH (Free ASH Whitepaper) 2021 are as follows:

Title: Engineering CD70-Directed CAR-NK Cells for the Treatment of Hematological and Solid Malignancies
Poster session: Abstract 1691, Session 703, Cellular Immunotherapies: Basic and Translational
Date and time: Saturday, December 11, 2021, from 5:30 – 7:30 p.m. ET
Location: Hall B5 at Georgia World Congress Center and via virtual meeting registration
Presenters: Eugene Choi (Principal Scientist, Catamaran Bio) and Celeste Richardson (SVP Research, Catamaran Bio)

On November 4, 2021 Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global, clinical-stage biotechnology company developing and manufacturing novel therapies, reported that 12 company-sponsored studies were accepted for presentation at the 63rd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Legend Biotech, NOV 4, 2021, View Source [SID1234594523]). These include two oral presentations and 10 poster presentations .

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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.

About CARTITUDE-2

CARTITUDE-2 (NCT04133636) is an ongoing Phase 2 multicohort study evaluating the safety and efficacy of cilta-cel in various clinical settings. Cohort A included patients who had progressive multiple myeloma after 1–3 prior lines of therapy, including PI and IMiD, were lenalidomide refractory, and had no prior exposure to BCMA-targeting agents. Cohort B included patients with early relapse after initial therapy that included a PI and IMiD. The primary objective was percentage of patients with negative minimal residual disease (MRD).2

About CARTITUDE-5

CARTITUDE-5 (NCT04923893) is a Phase 3 open-label study of bortezomib, lenalidomide, and dexamethasone (VRd) followed by cilta-cel vs. VRd followed by Rd maintenance, in patients with newly diagnosed MM for whom autologous stem cell transplant (ASCT) is not planned as initial therapy.

About LocoMMotion

LocoMMotion (NCT04035226) is a prospective non-interventional study evaluating the safety and efficacy of real-life standard-of-care treatments under routine clinical practice over a 24-month period in patients with RRMM. This study aims to understand the effectiveness of current standards of care in heavily pretreated patients with RRMM (reflecting real-world practice in the patient population progressing after PIs, IMiDs and anti-CD38 antibodies).

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.3 Although treatment may result in remission, unfortunately, patients will most likely relapse.4 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.5 Refractory multiple myeloma is when a patient’s disease is non-responsive or progresses within 60 days of their last therapy.6,7 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. 8 Patients who relapse after treatment with standard therapies, including protease inhibitors and immunomodulatory agents, have poor prognoses and few treatment options available.9

About Cilta-cel
Cilta-cel is an investigational chimeric antigen receptor T cell (CAR-T) therapy, formerly identified as JNJ-4528 in the U.S. and Europe and LCAR-B38M CAR-T cells in China, that is being studied in a comprehensive clinical development program for the treatment of patients with relapsed or refractory multiple myeloma and in earlier lines of treatment. The design consists of a structurally differentiated CAR-T with two BCMA-targeting single domain antibodies. In December 2017, Legend Biotech, Inc. entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel. In addition to a Breakthrough Therapy Designation (BTD) granted in the U.S. in December 2019, cilta-cel received a Priority Medicines (PRiME) designation from the European Commission in April 2019, and a BTD in China in August 2020. In addition, Orphan Drug Designation was granted for cilta-cel by the U.S. FDA in February 2019, and by the European Commission in February 2020. A Biologics License Application seeking approval of cilta-cel was submitted to the U.S. FDA and a Marketing Authorization Application was submitted to the European Medicines Agency.