Janssen Highlights Innovative Oncology Portfolio and Pipeline of Oral, Biologic and Cell Therapies Through ASCO20 Virtual Scientific Program
RARITAN, N.J.,?May 29, 2020?--?The Janssen Pharmaceutical Companies of Johnson & Johnson announced today the latest research from its innovative oncology portfolio and pipeline of novel oral, biologic and cell therapies is?now available as part of the American Society of Clinical Oncology (ASCO) Virtual Scientific Program. Among the data presented are longer-term results from the JNJ-4528 BCMA-directed CAR-T therapy Phase?1b/2?CARTITUDE-1 study?in relapsed or refractory multiple myeloma (RRMM); results from the?ERLEADA??(apalutamide)?Phase 3?SPARTAN study?reporting overall survival (OS) in non-metastatic castration-resistant prostate cancer (nmCRPC); and initial results?from Phase 1 studies of?amivantamab?(EGFRxMET bispecific antibody)?in non-small cell lung cancer (NSCLC); and?teclistamab?(BCMAxCD3 bispecific antibody) in RRMM. Further information about these studies and the science that Janssen is championing for patients is available via the?Janssen Oncology Virtual Newsroom.
"Through our discovery, development and collaborative efforts, we continue to advance a deep, differentiated portfolio and pipeline of small molecules, biologics and cell therapies for patients with hematologic malignancies, prostate cancer, lung cancer and bladder cancer," said?Peter Lebowitz, M.D., Ph.D., Global Therapeutic Area Head, Oncology, Janssen Research & Development, LLC. "We're proud to have achieved nine oncology drug approvals since 2011, 10 Breakthrough Therapy Designations and to be advancing six novel bispecific antibodies in the clinic. Our strategy is rooted in a deep understanding of disease, a scientific approach to transformational regimens and a movement towards cancer interception as we aim to realize our vision of the elimination of cancer."
Key Janssen Data Presentations Include:
Longer-Term Follow-Up Data for BCMA-Targeted CAR-T Therapy JNJ-4528 Show Early, Deep and Durable Responses in Heavily Pretreated Patients with Multiple Myeloma
An oral presentation of updated results from the Phase?1b/2 CARTITUDE-1 study of JNJ-4528 in patients with RRMM (Abstract #8505).
Final Analysis of Phase 3 SPARTAN Study Marks Second ERLEADA??Phase 3 Registrational Study to Show Overall Survival Benefit
The pre-planned final analysis demonstrating OS results from the Phase 3 SPARTAN study evaluating ERLEADA??in combination with androgen deprivation therapy (ADT) in patients with nmCRPC who are at high risk of metastases (Abstract #5516).
Amivantamab Data in the Treatment of Patients with Advanced Non-Small Cell Lung Cancer Harboring Exon 20 Insertion Mutations
Results from the Phase 1 CHRYSALIS study of amivantamab in patients with metastatic NSCLC with EGFR Exon 20 insertion mutations (Abstract #9512), which served as the basis of a U.S. Food and Drug Administration (FDA) Breakthrough Therapy Designation as?announced?in March.
First Data from Phase 1 Study of BCMAxCD3 Bispecific Teclistamab in Patients with Relapsed or Refractory Multiple Myeloma
An oral presentation of the first data from the Phase 1 study of teclistamab (Abstract #100), an investigational bispecific antibody targeting both BCMA and CD3 receptors on T-cells, in the treatment of patients with RRMM.
Data for IMBRUVICA??(ibrutinib), recently approved for a subsequent chronic lymphocytic leukemia indication, and DARZALEX?FASPROTM?(daratumumab and hyaluronidase-fihj), a new subcutaneous formulation recently approved for the treatment of multiple myeloma, will also be presented during the ASCO Virtual Scientific Program.
All Janssen-sponsored abstracts presented are listed below and abstracts presented for ZYTIGA??(abiraterone acetate) are available through the ASCO abstract database?here.
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Abstract No. |
Title |
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Portfolio Products |
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ERLEADA??(apalutamide) |
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Poster Discussion |
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Final Survival Results From SPARTAN, a Phase 3 Study of Apalutamide vs Placebo in Patients with nmCRPC |
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Poster Presentations |
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Molecular Determinants of Outcome for mCSPC with Addition of Apalutamide or Placebo to Androgen Deprivation Therapy in TITAN |
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PSA Kinetics in Patients with Advanced Prostate Cancer Treated with Apalutamide: Results from the TITAN and SPARTAN Studies |
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Molecular Determinants of PSA Kinetics and Clinical Response to Apalutamide in Patients with nmCRPC in SPARTAN |
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DARZALEX??(daratumumab) and DARZALEX?FASPRO? (daratumumab and hyaluronidase-fihj) |
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Poster Presentations |
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Corticosteroid Tapering in Patients with Relapsed or Refractory Multiple Myeloma (RRMM) Receiving Subcutaneous Daratumumab: Part 3 of the Open-label, Multicenter, Phase 1b PAVO Study |
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Daratumumab + Bortezomib, Thalidomide, and Dexamethasone (D-VTd) in Transplant-eligible Newly Diagnosed Multiple Myeloma: Baseline slimCRAB-based Subgroup Analysis of CASSIOPEIA |
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Subcutaneous Daratumumab in Patients with Multiple Myeloma Who Have Been Previously Treated with Intravenous Daratumumab: A Multicenter, Randomized, Phase 2 Study (LYNX) |
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Efficacy and Safety of Carfilzomib, Dexamethasone, Daratumumab (DKd) Twice-Weekly at 56 mg/m2 and Once-Weekly at 70 mg/m2 in RRMM: Cross-Study Comparison of CANDOR and MY1001* |
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Publication |
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Health Related Quality of Life (HRQoL) Outcomes from the Phase 3 CANDOR Study Comparing Carfilzomib, Dexamethasone, and Daratumumab (DKd) to Carfilzomib and Dexamethasone (Kd) in Patients with RRMM* |
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IMBRUVICA??(ibrutinib) |
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Poster Presentation |
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Clinical Activity of Cirmtuzumab, an Anti-ROR1 Antibody, in Combination with Ibrutinib; Interim Results of a Phase 1b/2 Study in MCL or CLL** |
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Publications |
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Toxicity Burden in Older Patients with CLL Receiving Bendamustine with Rituximab (BR) or Ibrutinib Regimens: Alliance A041202** |
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Real-World Healthcare Resource Utilization (HRU)/Costs associated with Venetoclax Treatment among CLL/SLL Patients |
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Real-world HRU and Costs among Relapsed/Refractory Mantle Cell Lymphoma Patients Receiving Ibrutinib or Chemoimmunotherapy (CIT) |
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BALVERSA??(erdafitinib) |
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Poster Discussion |
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BLC2001 Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma (UC): Long-Term Outcomes in BLC2001 |
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Poster Presentations |
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Clinical Outcomes and Economic Burden for Bladder Cancer Patients: An Analysis from a Swedish Cancer Registry |
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Evolving Development of PD-1 Therapy: Cetrelimab (JNJ-63723283) from Monotherapy to Combination with Erdafitinib |
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Publication |
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Use of a Dynamic Disease Progression Model to Estimate Prevalence and Prognosis for Patients with UC in the U.S. |
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Late-Stage Pipeline |
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JNJ-4528 |
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Oral Presentation |
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Update of CARTITUDE-1: A Phase 1B/2 Study of JNJ-4528, a BCMA-Directed CAR-T Cell Therapy, in RRMM |
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Publication |
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Medical Resource Utilization Among Multiple Myeloma Patients who were Triple-exposed to a Proteasome Inhibitor, an Immunomodulatory Agent, and Daratumumab |
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Patient Characteristics and Treatment Patterns in RRMM Patients After Exposure to a Proteasome Inhibitor, an Immunomodulatory Agent and Daratumumab |
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Treatment Patterns in Multiple Myeloma: Real-World Experience of the Triple Class Exposed Patient |
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Amivantamab |
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Poster Presentation |
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Amivantamab, an Anti-EGFR-MET Bispecific Antibody, in Patients with EGFR Exon 20 Insertion-Mutated NSCLC |
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Niraparib |
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Poster Presentations |
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A Phase 3 Randomized, Placebo-Controlled, Double-Blind Study of Niraparib Plus Abiraterone Acetate and Prednisone Versus Abiraterone Acetate and Prednisone in Patients with Metastatic Prostate Cancer (MAGNITUDE) |
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Association of Detectable Levels of Circulating Tumor DNA (ctDNA) with Disease Burden in Prostate Cancer |
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Early-Stage Pipeline |
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Teclistamab |
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Oral Presentation |
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Phase 1 Study of Teclistamab, a Humanized BCMA x CD3 Bispecific Antibody, in RRMM |
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Cusatuzumab |
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Poster Presentation |
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CULMINATE: A Phase 2 Study of Cusatuzumab + Azacitidine in Patients with Newly Diagnosed Acute Myeloid Leukemia, Ineligible for Intensive Chemotherapy |
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Lazertinib |
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Poster Presentations |
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Intracranial Anti-Tumor Activity of Lazertinib in Patients with Advanced NSCLC Who Progressed After Prior EGFR TKI Therapy: Data from a Phase 1/2 Study? |
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ctDNA Resistance Landscape of Lazertinib, a Third-Generation EGFR Tyrosine Kinase Inhibitor? |
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* Abstracts submitted by Amgen?in collaboration with Janssen Oncology
? Abstract submitted by Yuhan Corporation, which entered into a license and collaboration agreement with Janssen Biotech, Inc. for the development of lazertinib
** Abstracts were submitted by IMBRUVICA??co-developer partner, Pharmacyclics, an AbbVie company
About JNJ-4528
JNJ-4528 (LCAR-B38M) is an investigational CAR-T therapy for the treatment of patients with RRMM. In?December 2017, Janssen?entered?into an exclusive worldwide license and collaboration agreement with Legend Biotech to develop and commercialize JNJ-4528.?In?May 2018, Janssen?initiated?a Phase?1b/2 trial (NCT03548207) to evaluate the efficacy and safety of JNJ-4528 in adults with RRMM, informed by the LEGEND-2 study results.
In?December 2019, Janssen?announced?receipt of a Breakthrough Therapy Designation from the U.S. FDA, which is granted to expedite the development and regulatory review of an investigational medicine that is intended to treat a serious or life-threatening condition. In?February 2019, the U.S. FDA granted Janssen an Orphan Drug Designation for JNJ-4528, and in?February 2020, the European Commission granted Janssen an orphan designation for JNJ-4528. In February 2019,?JNJ-4528 was?granted?PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA).
About?ERLEADA?
ERLEADA??(apalutamide) is an androgen receptor inhibitor indicated for the treatment of patients with nonmetastatic castration-sensitive prostate cancer (nmCRPC) and for the treatment of patients with metastatic
