ASH 2024: Johnson & Johnson showcases innovations in multiple myeloma, B-cell malignancies, and autoimmune disorders

Johnson & Johnson announced more than 90 abstracts featuring data from the Company’s differentiated blood cancer portfolio and pipeline will be presented at the 66^th American Society of Hematology (ASH) Annual Meeting in San Diego from December 7-10. Clinical trial and real-world data will highlight the Company’s broad and expanding portfolio of hematologic therapies, deepening its leadership in novel approaches to treat multiple myeloma as well as myeloid and B-cell malignancies. Six additional abstracts focus on the Company’s commitment and patient insights in warm autoimmune hemolytic anemia (wAIHA), a rare autoantibody-driven disease, and fetal and neonatal alloimmune thrombocytopenia (FNAIT), an alloimmune disorder of pregnancy.

“This year’s data line-up at ASH highlights our unwavering commitment to transform outcomes for patients with hematologic malignancies,” said Yusri Elsayed, M.D., M.H.Sc., Ph.D., Global Therapeutic Area Head, Oncology, Johnson & Johnson Innovative Medicine. “Our relentless pursuit to provide each person diagnosed with blood cancer with treatment options at every stage of their disease inspires us to continue driving innovation in this space.”

“The breadth of scientific evidence being presented at ASH speaks to our drive to deliver life-changing treatments for patients with blood cancer,” said June Lanoue, U.S. President, Hematology, Johnson & Johnson Innovative Medicine. “We look forward to highlighting the latest clinical trial and real-world data that demonstrate how we are addressing unmet needs for these patients.”

 

New data highlight progress across all treatment stages of multiple myeloma, including differentiated and promising combination regimens.

Key clinical and real-world studies focus on providing healthcare professionals with important data that may help better inform their choice of treatment regimens for patients, including:

• Phase III Randomized Study of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) Monotherapy Versus Active Monitoring in Patients with High-Risk Smoldering Multiple Myeloma: Primary Results of the AQUILA Study (Oral #733)
• Phase III Randomized Study of DARZALEX FASPRO® + Bortezomib, Lenalidomide and Dexamethasone (VRd) Versus VRd Alone in Patients with Transplant-Ineligible Newly Diagnosed Multiple Myeloma or for Whom Transplant is Not Planned as Initial Therapy: Analysis of Minimal Residual Disease in the CEPHEUS Trial (Oral #362)
• DARZALEX FASPRO® Plus Lenalidomide Versus Lenalidomide Alone as Maintenance Therapy in Newly Diagnosed Multiple Myeloma After Transplant: Analysis of the Phase 3 AURIGA Study Among Clinically Relevant Subgroups (Oral #654)
• Subcutaneous DARZALEX FASPRO® + Bortezomib, Cyclophosphamide, and Dexamethasone (VCD) in Patients with Newly Diagnosed Light Chain Amyloidosis: Overall Survival and Final Major Organ Deterioration Progression-Free Survival Results from the Phase 3 ANDROMEDA Study (Oral #891)
• CARVYKTI (ciltacabtagene autoleucel; cilta-cel) vs Standard of Care in Patients with Lenalidomide-Refractory Multiple Myeloma After 1–3 Lines of Therapy: Minimal Residual Disease Negativity in the Phase 3 CARTITUDE-4 Trial (Oral #1032)
• Phase III Study of TECVAYLI (teclistamab-cqyv) in Combination with Lenalidomide and TECVAYLI® Alone Versus Lenalidomide Alone in Newly Diagnosed Multiple Myeloma as Maintenance Therapy Following Autologous Stem Cell Transplantation: Safety Run-in Results from the MajesTEC-4/EMN30 Trial (Oral #494)
• Phase II Study of TECVAYLI-Based Induction Regimens in Patients with Transplant-eligible Newly Diagnosed Multiple Myeloma: Results From the GMMG-HD10/DSMM-XX (MajesTEC-5) Trial (Oral #493)
• Pharmacodynamic Signatures and Correlatives of Response in Patients with Relapsed/Refractory Multiple Myeloma Treated with TALVEY® (talquetamab-tgvs) or TECVAYLI® Plus DARZALEX® (daratumumab) and Pomalidomide (Oral #594)

Continued clinical innovation in treatment of B-cell malignancies to be shown through new and updated data.

Ongoing studies of IMBRUVICA^® (ibrutinib) fixed-duration combination provide an opportunity to demonstrate long-term benefits of IMBRUVICA^® in chronic lymphocytic leukemia. Key presentations:

• First-Line IMBRUVICA^® Plus Venetoclax vs Chlorambucil Plus Obinutuzumab in Elderly or Comorbid Patients with Chronic Lymphocytic Leukemia: GLOW Study 64-Month Follow-Up and Adverse Event-Free Progression-Free Survival Analysis (Poster #1871)
• Consistently High 5.5-Year Progression-Free Survival Rates in Patients with and without Bulky Baseline Lymphadenopathy ≥5 cm are Associated with High Undetectable Minimal Residual Disease (uMRD4) Rates After First-Line Treatment with Fixed-Duration Ibrutinib + Venetoclax for Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma in the Phase 2 CAPTIVATE Study (Poster #1869)
• Initiating First-Line Fixed-Duration IMBRUVICA^® and Venetoclax in Patients with Chronic Lymphocytic Leukemia Improves Overall Survival Outcomes to Rates Approximating an Age-Matched General European Population (Poster #3254)

A suite of oral presentations from independent investigators will further inform the clinical understanding and application of IMBRUVICA^® in chronic lymphocytic leukemia, as well as its potential in the treatment of previously untreated mantle cell lymphoma.

Phase 1 program for the menin inhibitor bleximenib demonstrates commitment to addressing unmet needs in acute myeloid leukemia for patients with both KMT2Ar and NPM1m alterations.

Johnson & Johnson is investigating new targets with a focus on unmet needs in myeloid malignancies. Data will be presented from the Company’s lead asset for the treatment of acute myeloid leukemia in both newly diagnosed and relapsed/refractory patients:

• Phase 1b Study of Menin-KMT2A Inhibitor Bleximenib in Combination with Intensive Chemotherapy in Newly Diagnosed Acute Myeloid Leukemia with KMT2Ar or NPM1 Alterations (Oral #215)
• Bleximenib Dose Optimization and Determination of RP2D From a Phase 1 Study in Relapsed/Refractory Acute Leukemia Patients with KMT2A and NPM1 Alterations (Oral #212)

Research showcases unmet need in hematologic allo- and autoantibody-driven diseases including wAIHA and FNAIT.

Hematology Johnson & Johnson studies on the lived experience of patients and utilization of health resources in people living with wAIHA highlight the hardship faced by those impacted by the disease and need for research into investigational treatment options that may offer sustained disease control and minimize disease exacerbations. Additionally, an overview of an ongoing Phase 3 FNAIT clinical study design will be shared.

• Health Resource Utilization Among Patients with Warm Autoimmune Hemolytic Anemia in Sweden: A Retrospective Registry-Based Study (Poster #2255)
• A Retrospective Database Analysis of Healthcare Resource Utilization in Patients with Warm Autoimmune Hemolytic Anemia in the United States (Poster #2324)
• Sentiment analysis applied to digital conversations among Warm Autoimmune Hemolytic Anemia patients receiving rituximab and/or blood transfusion (Poster #3705)
• Design of a Phase III, Multicenter, Randomized, Open-Label Study of Nipocalimab or IVIG in Pregnancies at Risk for Fetal and Neonatal Alloimmune Thrombocytopenia (FREESIA-3) (Poster #1193.1)
• Insights on the Lived Experience of Warm Autoimmune Hemolytic Anemia from an Ongoing Patient Council (Online Only)
• Qualitative Examination of Treatment Experiences Among Individuals Living with Warm Autoimmune Hemolytic Anemia (Online Only)