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Johnson & Johnson News
JANSSEN TO HIGHLIGHT SCIENTIFIC ADVANCES AT ASCO AND EHA
Janssen will also highlight its commitment to transform cancer care with more than 90 presentations showcasing robust, differentiated portfolio and pipeline in hematologic malignancies and solid tumours.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting will feature 50 presentations from the Company’s robust oncology portfolio and pipeline in hematologic malignancies and solid tumours and 45 additional abstracts will be presented at the European Hematology Association (EHA) 2023 Congress the following week. More than 15 oral presentations and more than 20 investigator-initiated studies will feature new data and updates in multiple myeloma, B-cell malignancies, lung cancer, prostate cancer, and bladder cancer across the Janssen portfolio.
Key ASCO and EHA Data Presentations
Progressing a commitment to hematology innovation, science, and patient care across lines of treatment and through novel combinations
Commitment to Multiple Myeloma
- Janssen will feature new and updated data from its robust portfolio, including therapies for all lines of treatment and data on novel targets and combination regimens to address the needs of patients with this complex, heterogeneous disease.
- At EHA, Janssen will reinforce its commitment to improving outcomes, patient experience, and care disparities in multiple myeloma through the launch of a first-of-its-kind Global Multiple Myeloma Call-to-Action (CTA). This CTA has been developed by a multidisciplinary council including clinical leaders, patient advocates, and policy experts from across the globe, supported by Janssen. It focuses on areas of greatest unmet need in multiple myeloma with the aim of unifying the global community around common goals and inspiring action to shape the future of multiple myeloma care.
Multiple Myeloma
- At ASCO, an oral presentation on the Phase 3 randomized CARTITUDE-4 study of CARVYKTI® provides the pivotal data compared to standard-of-care regimens in patients with lenalidomide-refractory multiple myeloma who have had one to three prior lines of treatment. These data will also be featured in the plenary session at EHA. These results will underscore the potential of CARVYKTI® in providing therapy for patients with relapsed and lenalidomide refractory multiple myeloma, (Abstracts #LBA106 and #S100, respectively).
- First reported data from the Phase 1b RedirecTT-1 study evaluating the treatment combination of two of Janssen’s bispecific antibodies, TECVAYLI® (teclistamab-cqyv, BCMAxCD3) and talquetamab (GPRC5DxCD3), in patients with relapsed or refractory multiple myeloma (RRMM) will be presented at ASCO and EHA as oral presentations, (Abstracts #8002 and #S190, respectively). This is the first and only data combining two T-cell redirecting antibodies in multiple myeloma.
- Updated data from the TRIMM-2 study, including responses in patients treated with prior T-cell redirecting therapies, will be presented in an oral presentation at ASCO, studying talquetamab in combination with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj), (Abstract #8003).
- In RRMM, longer-term follow-up data from the MajesTEC-1 study, which led to the U.S. FDA approval of TECVAYLI® in 2022, will be presented as a poster at both ASCO and EHA, (Abstracts #8011 and #P879, respectively). Data from the MajesTEC-1 study evaluating prophylactic tocilizumab for the reduction of cytokine release syndrome (CRS) and data highlighting a biweekly dosing schedule of TECVAYLI® will be featured as poster presentations, (Abstracts #8033 and #8034, respectively).
- Updated Phase 1/2 data from the pivotal MonumenTAL-1 study of talquetamab, in addition to longer-term follow-up data at both recommended Phase 2 doses (RP2Ds), will be presented via a poster at each meeting, (Abstracts #8036 and #P892, respectively). Additionally, findings from an analysis of infections and parameters of humoral immunity in patients with RRMM treated with talquetamab in the MonumenTAL-1 study will be presented at ASCO, (Abstract #8020).
- In newly diagnosed multiple myeloma (NDMM), a poster presentation at ASCO will feature an indirect treatment comparison of two core frontline triplet regimens. This comparison is based on data from the Phase 3 MAIA trial, evaluating DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone (DRd) compared to Rd alone in transplant-ineligible patients, and the Phase 3 SWOG SO777 trial evaluating bortezomib in combination with lenalidomide and dexamethasone (VRD) versus Rd, (Abstract #8037).
B-cell Malignancies
- Four-year follow-up data from the fixed-duration (FD) cohort of the Phase 2 CAPTIVATE study will be featured in a poster presentation at each meeting. This study evaluates an investigational combination regimen of IMBRUVICA® (ibrutinib) plus venetoclax (I+V) for newly diagnosed chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL), (Abstracts #7535 and #P617, respectively).
Advancing the science of solid tumours through precision medicine
Janssen’s continued innovation in solid tumors focuses on advancing precision medicine options for patients with biomarker-driven disease who have limited targeted treatment options and moving patients into earlier lines of therapy when treatments may be more effective.
Janssen’s continued innovation in solid tumors focuses on advancing precision medicine options for patients with biomarker-driven disease who have limited targeted treatment options and moving patients into earlier lines of therapy when treatments may be more effective.
Lung Cancer
- An oral presentation will report results from Cohort D of the CHRYSALIS-2 study on efforts to identify predictive biomarkers for treatment with RYBREVANT® (amivantamab-vmjw) plus lazertinib among patients with epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC) in the post-osimertinib setting, (Abstract #9013).
- Longer-term follow-up data from the CHRYSALIS study evaluating RYBREVANT® in combination with lazertinib as a first-line therapy in patients with locally advanced or metastatic NSCLC with common EGFR mutations will be presented as a poster, (Abstract #9134).
- Updated safety results from the Phase 1b PALOMA study evaluating the investigational use of subcutaneous RYBREVANT® in patients with advanced solid tumors will also be presented as a poster, (Abstract #9126).
GU Cancers
- A late-breaking oral presentation will report the final analysis from Cohort 1 of the Phase 3 THOR confirmatory study, evaluating BALVERSA® (erdafitinib) versus chemotherapy in patients with advanced or metastatic urothelial cancer (mUC) with susceptible fibroblast growth factor receptor (FGFR) alterations, (Abstract #LBA4619).
- Two additional oral presentations at ASCO from Janssen’s bladder cancer clinical program include the final results from the Phase 2 NORSE study evaluating BALVERSA® alone and in combination with cetrelimab in patients with mUC and FGFR alterations and results from the pediatric Match Trial A, evaluating BALVERSA® in children with FGFR-altered tumors, (Abstracts #4504 and #10007, respectively).
- An oral presentation will report data from CAPTURE, a real-world evidence study evaluating somatic/germline homologous recombination repair (HRR) mutations and outcomes in patients with metastatic castration-resistant prostate cancer (mCRPC) receiving first-line treatment stratified by BRCA status, (Abstract #5003).
- Overall, six poster presentations at ASCO will highlight data evaluating ERLEADA® (apalutamide) in patients with high-risk localized prostate cancer undergoing radical prostatectomy (ARA-RP), high-risk biochemical relapsed prostate cancer (AFT-19 PRESTO), PSA recurrent prostate cancer (STARTAR), and treatment response in Black and white patients with mCRPC (PANTHER), (Abstracts #5010, #5077, #5016, and #5095, respectively), and evaluating prognostic and predictive abilities of histopathology-based artificial intelligence scores in patients with nmCRPC treated with ERLEADA®, (Abstracts #5035 and #5027, respectively).
Tumour Agnostic Disease
- Janssen will present a poster highlighting final data from the RAGNAR study, evaluating the efficacy and safety of BALVERSA® in patients with advanced solid tumors with prespecified FGFR alterations, (Abstract #3121). RAGNAR is a Phase 2 open-label, single-arm, tumor-agnostic trial investigating the efficacy and safety of BALVERSA® in pretreated adult and pediatric patients with advanced solid tumors and FGFR alternations.
Furthering autoantibody acience for patients with wAIHA
Janssen continues to advance its Phase 2/3 clinical study exploring nipocalimab, a fully human IgG1 antibody neonatal crystallizable fragment receptor (FcRn) blocker designed to address the underlying cause of autoantibody disease by reducing pathogenic antibodies while maintaining immune function in adults with warm Autoimmune Hemolytic Anemia (wAIHA). wAIHA is a rare, life-threatening autoimmune disorder caused by autoantibodies that attach to and prematurely destroy healthy red blood cells. Nipocalimab received Fast Track Designation for wAIHA in 2019.
A de novo poster presentation on the characteristics, treatment patterns and healthcare utilization of patients with wAIHA initiating first-line therapy of oral corticosteroids (OCS) with or without rituximab (OCS+R) (EHA Abstract #P1697), will describe real-world treatment patterns and healthcare resource utilization (HCRU) of patients with wAIHA initiating first-line therapy of OCS+R compared to OCS and will illustrate the significant burden of disease and unmet patient need in this rare disease.
A complete list of Janssen-sponsored abstracts at ASCO and EHA is available at: Janssen.com/ASCO2023
Janssen continues to advance its Phase 2/3 clinical study exploring nipocalimab, a fully human IgG1 antibody neonatal crystallizable fragment receptor (FcRn) blocker designed to address the underlying cause of autoantibody disease by reducing pathogenic antibodies while maintaining immune function in adults with warm Autoimmune Hemolytic Anemia (wAIHA). wAIHA is a rare, life-threatening autoimmune disorder caused by autoantibodies that attach to and prematurely destroy healthy red blood cells. Nipocalimab received Fast Track Designation for wAIHA in 2019.
A de novo poster presentation on the characteristics, treatment patterns and healthcare utilization of patients with wAIHA initiating first-line therapy of oral corticosteroids (OCS) with or without rituximab (OCS+R) (EHA Abstract #P1697), will describe real-world treatment patterns and healthcare resource utilization (HCRU) of patients with wAIHA initiating first-line therapy of OCS+R compared to OCS and will illustrate the significant burden of disease and unmet patient need in this rare disease.
A complete list of Janssen-sponsored abstracts at ASCO and EHA is available at: Janssen.com/ASCO2023
