A Phase I/Ib Study of JNJ-75276617 in Combination With Conventional Chemotherapy for Pediatric and Young Adult Participants With Relapsed/Refractory Acute Leukemias Harboring KMT2A, NPM1, or Nucleoporin Gene Alterations

The purpose of this study is to determine the recommended Phase 2 dose(s) (RP2Ds) of JNJ-75276617 in combination with a conventional chemotherapy backbone in pediatric and young adult participants with relapsed/refractory acute leukemia harboring histone-lysine N-methyltransferase 2A1 ([KMT2A1], nucleophosmin 1 gene (NPM1), or nucleoporin alterations in Part 1 (Dose Escalation) and to further evaluate safety at the RP2D(s) of JNJ-75276617 in combination with chemotherapy in pediatric and young adult participants with relapsed/refractory acute leukemia harboring KMT2A1, NPM1, or nucleoporin alterations and safety at the RP2D(s) of JNJ-75276617 as monotherapy in a select low burden of disease cohort in Part 2 (Dose Expansion).

Start Date26 Dec 2025

Sponsor / Collaborator

Janssen Research & Development LLC

NCT06738368

/ Not yet recruitingPhase 2IIT

Dose-Adjusted Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) ± Rituximab + Recombinant Erwinia Asparaginase (JZP458; Rylaze®) for the Treatment of Newly-Diagnosed Adults With Philadelphia Chromosome-Negative Acute Lymphoblastic Lymphoma/Leukemia

This phase II trial tests how well etoposide, prednisone, vincristine, cyclophosphamide and doxorubicin (DA-EPOCH) with or without rituximab plus recombinant Erwinia asparaginase (JZP458) works in treating patients with newly diagnosed Philadelphia chromosome (Ph) negative B-acute lymphoblastic leukemia (ALL) or T-ALL. Chemotherapy drugs, such as etoposide, vincristine, cyclophosphamide and doxorubicin, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Anti-inflammatory drugs, such as prednisone, lower the body's immune response and are used with other drugs in the treatment of some types of cancer. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. JZP458 may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving DA-EPOCH with or without rituximab plus JZP458 may kill more cancer cells in patients with newly diagnosed Ph negative B-ALL or T-ALL.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Washington

[+1]

NCT06317662

/ Not yet recruitingPhase 2IIT

A Phase 2 Study of Blinatumomab in Combination With Chemotherapy for Infants With Newly Diagnosed Acute Lymphoblastic Leukemia With Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

This phase II trial tests the addition of venetoclax and/or blinatumomab to usual chemotherapy for treating infants with newly diagnosed acute lymphoblastic leukemia (ALL) with a KMT2A gene rearrangement (KMT2A-rearranged [R]) or without a KMT2A gene rearrangement (KMT2A-germline [G]). Venetoclax is in a class of medications called B-cell lymphoma-2 (Bcl-2) inhibitors. It may stop the growth of cancer cells by blocking Bcl-2, a protein needed for cancer cell survival. Blinatumomab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Chemotherapy drugs work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Adding venetoclax and/or blinatumomab to standard chemotherapy may be more effective at treating patients with ALL than standard chemotherapy alone, but it may also cause more side effects. This clinical trial evaluates the safety and effectiveness of adding venetoclax and/or blinatumomab to chemotherapy for the treatment of infants with KMT2A-R or KMT2A-G ALL.

Start Date26 Apr 2025

Sponsor / Collaborator

National Cancer Institute

100 Clinical Results associated with Vincristine Sulfate

100 Translational Medicine associated with Vincristine Sulfate

100 Patents (Medical) associated with Vincristine Sulfate

31,186

Literatures (Medical) associated with Vincristine Sulfate

01 Dec 2025·CHILDS NERVOUS SYSTEM

Holocord intramedullary pilocytic astrocytoma mimicking holocord spinal abscess: a case report and literature review

Review

Author: Erguven, Merve ; Sabanci, Pulat Akin ; Dolen, Duygu ; Gulsever, Cafer Ikbal ; Unverengil, Gokcen

PURPOSE:

This report aims to present a case of a child with holocord pilocytic astrocytoma and review the existing literature to provide insights into current management strategies.

CASE PRESENTATION:

An 11-month-old patient presented with progressive quadriplegia and was initially diagnosed with a spinal abscess. MRI revealed a heterogeneously enhancing cystic intramedullary lesion extending from the cervicomedullary region to the conus medullaris. The patient underwent an emergent T10-L1 total laminectomy and midline myelotomy for presumed abscess drainage. Intraoperative findings, however, were inconsistent with an abscess, suggesting a neoplastic process. Postoperative MRI indicated persistent spinal cord compression and histopathological examination showed no leukocytes or microorganisms. A second surgery the following day extended the laminectomy to T3, achieving gross total resection. Pathology confirmed a grade I pilocytic astrocytoma. Given the patient's age, chemotherapy with vincristine and carboplatin was initiated, as radiotherapy was unsuitable. Early physical therapy was commenced, resulting in significant neurological improvement to 4/5 muscle strength in all extremities according to the Medical Research Council (MRC) scale in the first year. Chemotherapy was discontinued due to systemic complications. At the 1-year follow-up, MRI demonstrated no tumor recurrence.

CONCLUSION:

The management of holocord pilocytic astrocytomas presents significant challenges, particularly in pediatric patients. While surgical resection remains the cornerstone of treatment, the role of chemotherapy requires further investigation. This case underscores the necessity of a multidisciplinary approach and highlights the potential for favorable outcomes with appropriate intervention.

01 Apr 2025·DEN open

Unique endoscopic features of primary biliary diffuse large B‐cell lymphoma: A case report with literature review (with video)

Article

Author: Kameyama, Naohiro ; Ishigami, Keisuke ; Nakase, Hiroshi ; Masaki, Yoshiharu ; Kawakami, Yujiro ; Sugawara, Taro ; Nakamura, Tomoya ; Satoh, Shuji ; Sugita, Shintaro ; Takada, Yumemi

Abstract:

A 67‐year‐old man visited our hospital complaining of dark‐colored urine and upper abdominal pain. Magnetic resonance cholangiopancreatography showed stricture of the distal bile duct, and contrast‐enhanced computed tomography showed irregular thickening of the distal bile duct wall. However, no enlarged lymph nodes, pancreatic tumors, or other neoplastic lesions were apparent around the bile duct. Endoscopic ultrasonography and intraductal ultrasonography showed irregular thickening of the inner hypoechoic layer without the disappearance of the innermost thin hyperechoic layer. On the basis of these findings, we considered that the bile duct lesion was of non‐epithelial origin. Thus, we repeatedly performed bile duct biopsies from the same site under fluoroscopy to obtain a sample of the submucosal tissue. The pathological diagnosis was diffuse large B‐cell lymphoma, and the patient received systemic chemotherapy (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone). After six courses of rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone, positron emission tomography‐computed tomography showed the disappearance of 18‐fluorodeoxyglucose uptake in the bile duct and endoscopic retrograde cholangiography showed improvement of the bile duct stricture. Endoscopic findings and repeated biopsies were useful in making the diagnosis of primary biliary diffuse large B‐cell lymphoma.

01 Apr 2025·DEN open

Dynamic endoscopic progression of gastrointestinal tract involvement in Langerhans cell histiocytosis: A pediatric case report

Article

Author: Li, Zhongyue ; Liu, Bo ; Zhang, Huihua ; Pan, Jianwei

Abstract:

Gastrointestinal tract involvement in Langerhans cell histiocytosis (LCH) is extremely rare, with limited documentation of endoscopic manifestations. We report a 19‐month‐old girl who presented with repeated diarrhea and bloody stools, accompanied by recurrent pulmonary infections, anemia, hypoproteinemia, thrombocytopenia, coagulopathy, and hepatosplenomegaly with lymphadenopathy. Initial treatment with antibacterial agents, mesalazine, thalidomide, and prednisone led to temporary improvement; however, the symptoms repeatedly relapsed. She underwent three digestive endoscopies, but until the third endoscopy, a definitive diagnosis of Langerhans cell histiocytosis was established through biopsy. While upper gastrointestinal tract findings were not significant, notable changes were observed in the colorectal region. A colonoscopy revealed progression from erythema to diffuse hyperemia and edema, with erythema, erosion, and superficial ulcers extending into the distal ileal mucosa. Genetic analysis identified a BRAF‐V600E mutation. Following treatment with chemotherapy (vincristine and prednisone) and the BRAF inhibitor dabrafenib, the patient demonstrated significant clinical improvement within days. At the 1‐year follow‐up, the patient had normal bowel movements and a weight gain of 2.5 kg. Early gastrointestinal endoscopy with multiple biopsies in suspected children can facilitate early detection. Dabrafenib is a viable treatment option for Langerhans cell histiocytosis.

100

News (Medical) associated with Vincristine Sulfate

06 Feb 2025

·www.businesswire.com

Merck Announces Phase 3 waveLINE-010 Trial Initiation Evaluating Zilovertamab Vedotin, an Investigational Antibody-Drug Conjugate, for the Treatment of Patients With Previously Untreated Diffuse Large B-Cell Lymphoma

RAHWAY, N.J.--( BUSINESS WIRE )--Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced the initiation of waveLINE-010, a pivotal Phase 3 clinical trial evaluating zilovertamab vedotin in combination with rituximab plus cyclophosphamide, doxorubicin and prednisone (R-CHP) compared to rituximab plus cyclophosphamide, doxorubicin, vincristine and prednisone (R-CHOP) alone, for the treatment of patients with previously untreated diffuse large B-cell lymphoma (DLBCL). Zilovertamab vedotin is Merck’s investigational antibody-drug conjugate (ADC) that targets receptor tyrosine kinase-like orphan receptor 1 (ROR1). Global recruitment of the waveLINE-010 trial has begun, with patients now enrolling. “ Following the encouraging results observed in the Phase 2 waveLINE-007 trial, we look forward to evaluating the potential clinical benefits of a combination regimen with zilovertamab vedotin in patients with diffuse large B-cell lymphoma compared to the current standard treatment,” said Dr. Gregory Lubiniecki, vice president, oncology clinical research, Merck Research Laboratories. “ ADCs have shown promise as an important modality in the treatment of different cancer types, and the initiation of this Phase 3 waveLINE clinical trial demonstrates our commitment to researching zilovertamab vedotin to help address unmet needs for patients with this aggressive and most common form of non-Hodgkin lymphoma.” WaveLINE-010 is a randomized, open-label Phase 3 trial (ClinicalTrials.gov, NCT06717347 ), which is enrolling an estimated 1,046 patients globally. The primary endpoint is progression-free survival (PFS), and secondary endpoints include complete response (CR) rate at the end of the treatment, overall survival, event-free survival, duration of CR and safety. Zilovertamab vedotin is currently being evaluated in the Phase 2/3 waveLINE-003 dose confirmation and expansion trial ( NCT05139017 ) for the treatment of relapsed or refractory DLBCL and in the Phase 2 waveLINE-007 trial ( NCT05406401 ) in combination with R-CHP in patients with previously untreated DLBCL. Merck recently presented data from this trial for the first time at the 66 th American Society of Hematology Annual Meeting and Exposition in December 2024. About diffuse large B-cell lymphoma Lymphoma is cancer beginning in the lymphatic system – the network of organs, vessels and tissues that protects the body from infection. There are many subtypes of lymphoma, which is often categorized into two main types – Hodgkin lymphoma and non-Hodgkin lymphoma (NHL). Diffuse large B-cell lymphoma, the most common form of NHL, is derived from white blood cells that grow rapidly and uncontrollably, enlarging the lymph nodes and often migrating to other parts of the body. DLBCL accounts for approximately 25-30% of all NHLs worldwide. In the U.S., it is estimated that approximately 25,000 patients are diagnosed with DLBCL each year. The five-year relative survival rate for DLBCL is 60-70%. About zilovertamab vedotin (MK-2140) Zilovertamab vedotin is an investigational ADC that targets ROR1. ROR1 is a transmembrane protein that is overexpressed in multiple hematologic malignancies. Merck is committed to research with zilovertamab vedotin across B-cell malignancies and is establishing a robust program of clinical trials under the name waveLINE. The waveLINE program includes a Phase 2/3 study in patients with relapsed or refractory DLBCL (waveLINE-003, NCT05139017 ) and a Phase 2 study in patients with previously untreated DLBCL (waveLINE-007, NCT05406401 ). About Merck in hematology Merck is committed to advancing innovation and care for people with hematologic neoplasms and malignancies. Building on its leadership in oncology, the company has a broad clinical development program that evaluates novel mechanisms of action to address longstanding unmet needs for patients with hematologic disorders. Among Merck’s research efforts are studies evaluating multiple investigational medicines as monotherapy or in combination with other therapies across a range of hematologic neoplasms and malignancies. Merck’s focus on cancer Every day, we follow the science as we work to discover innovations that can help patients, no matter what stage of cancer they have. As a leading oncology company, we are pursuing research where scientific opportunity and medical need converge, underpinned by our diverse pipeline of more than 25 novel mechanisms. With one of the largest clinical development programs across more than 30 tumor types, we strive to advance breakthrough science that will shape the future of oncology. By addressing barriers to clinical trial participation, screening and treatment, we work with urgency to reduce disparities and help ensure patients have access to high-quality cancer care. Our unwavering commitment is what will bring us closer to our goal of bringing life to more patients with cancer. For more information, visit https://www.merck.com/research/oncology . About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ).

Phase 2Phase 3ASH

08 Jan 2025

·www.businesswire.com

Asher Bio Announces Clinical Trial Collaboration and Supply Agreement on Etakafusp Alfa (AB248) in Combination with Bispecific T-cell Engager in Patients with Small Cell Lung Cancer

SOUTH SAN FRANCISCO, Calif.--( BUSINESS WIRE )--Asher Biotherapeutics, a biotechnology company developing precisely-targeted immunotherapies for cancer and infectious diseases, today announced a clinical trial collaboration and supply agreement with Amgen (NASDAQ:AMGN) to evaluate etakafusp alfa (formerly known as AB248), Asher Bio’s investigational CD8+ T cell targeted interleukin-2 (IL-2) immunotherapy, in combination with IMDELLTRA ® (tarlatamab), Amgen’s DLL3-targeting Bispecific T-cell Engager (BiTE ® ) therapy, in patients with extensive-stage small cell lung cancer (ES-SCLC). “ This clinical trial collaboration and supply agreement with Amgen allows us to further expand on the Phase 1 results for etakafusp alfa in a new combination with IMDELLTRA ® in a global Phase 1b study in ES-SCLC,” said Don O’Sullivan, Ph.D., Chief Business Officer of Asher Bio. “ Based on emerging data to date, we believe etakafusp alfa has the potential to improve the efficacy of T cell engagers (TCEs) by selectively expanding the CD8+ T cell population, improving effector function, tumor infiltration and reversing TCE-induced T cell desensitization. We look forward to collaborating with Amgen to assess the potential for the novel combination to improve outcomes for patients with ES-SCLC.” As part of this collaboration agreement, Amgen will sponsor and operationalize a global Phase 1b study to evaluate the safety and early efficacy of etakafusp alfa in combination with IMDELLTRA ® in patients with ES-SCLC. Asher Bio will retain full ownership of etakafusp alfa and will supply Amgen with etakafusp alfa at no cost. About SCLC SCLC is one of the most aggressive and devastating solid tumor malignancies, with a median survival of approximately 12 months following initial therapy and a 3% five-year relative survival rate for ES-SCLC. 1,2,3 Current second-line treatments impart a short duration of response (median DoR: 3.3–5.3 months) and limited survival (median OS: 5.8-9.3 months), while current third-line treatments for SCLC, which consist primarily of chemotherapy, yield a short median DoR of 2.6 months and a median OS of 4.4-5.3 months. 4-8 SCLC comprises ~15% of the 2.4 million plus patients diagnosed with lung cancer worldwide each year. 9-11 Despite initial high response rates to first-line platinum-based chemotherapy, most patients quickly relapse within months and require subsequent treatment options. 13 About Etakafusp Alfa ( AB248) Etakafusp Alfa ( AB248 ) is a novel CD8+ T cell selective IL-2, generated by fusing a reduced potency IL-2 mutein to an anti-CD8β antibody. It was specifically engineered to selectively and potently activate CD8+ T-cells which are the immune cells that drive anti-tumor efficacy, while avoiding natural killer (NK) cells, which can act as a pharmacological sink and contribute to toxicity, and regulatory T (Treg) cells, which are immunosuppressive. Asher Bio is currently evaluating etakafusp alfa in a Phase 1a/1b clinical trial, AB248-101. The trial consists of a dose escalation and expansion phase to investigate the safety, pharmacokinetics (PK), pharmacodynamics (PD), and anti-tumor activity of etakafusp alfa alone and in combination with pembrolizumab in subjects with locally advanced/metastatic solid tumors who failed prior therapies. Initial pharmacokinetic and pharmacodynamic data from the ongoing Phase 1a/1b clinical trial support etakafusp alfa’s proof of mechanism and activity with a highly differentiated clinical profile. Early data shows potent and selective CD8+ T cell activation without substantial changes to Treg and NK cell numbers and initial evidence of anti-tumor activity, including confirmed objective responses, with a generally well-tolerated safety profile. Please refer to www.clinicaltrials.gov (NCT05653882) for additional details related to this Phase 1a/1b clinical trial. About Asher Bio Asher Bio is a biotechnology company developing therapies to precisely engage specific immune cells to fight cancer and chronic viral infection. We utilize our proprietary cis-targeting platform to develop therapies engineered to overcome limitations of other immune-based treatments by selectively activating specific immune cell types with validated disease fighting functionality. Our candidates feature an antibody connected to a modified immunomodulatory protein, such as a cytokine. Our candidate design is intended to enable our candidates to selectively activate the desired immune cells and not other cells that contribute to toxicity or immune suppression. Our lead program etakafusp alfa (AB248), an IL-2 molecule specifically targeted to CD8+ effector T cells, is currently in Phase 1 trials for oncology. Our broader portfolio includes AB821, an IND-ready CD8-targeted IL-21 immunotherapy, and early-stage programs targeting CAR-T cells, myeloid cells and CD4+ T cells. Asher Bio was founded by Ivana Djuretic and Andy Yeung with support from Third Rock Ventures and is located in South San Francisco. For more information, please visit http://www.asherbio.com and follow us on X (formerly Twitter) @ AsherBio and on LinkedIn . 1 American Cancer Society. Lung Cancer Survival Rates. 2 Paz-Ares L, Chen Y, Reinmuth N, et al. Durvalumab, with or without tremelimumab, plus platinum-etoposide in first-line treatment of extensive-stage small-cell lung cancer: 3-year overall survival update from CASPIAN. ESMO Open. 2022;7:100408. 3 Liu SV, Reck M, Mansfield AS, et al. Updated Overall Survival and PD-L1 Subgroup Analysis of Patients With Extensive-Stage Small-Cell Lung Cancer Treated With Atezolizumab, Carboplatin, and Etoposide (IMpower133). J Clin Oncol. 2021;39:619-630. 4 Trigo J, Subbiah V, Besse B, et al. Lurbinectedin as second-line treatment for patients with small-cell lung cancer: a single-arm, open-label, phase 2 basket trial. Lancet Oncol. 2020;21(5):645-654. 5 Von Pawel J, Schiller JH, Shepherd FA, et al. Topotecan versus cyclophosphamide, doxorubicin, and vincristine for the treatment of recurrent small-cell lung cancer. J Clin Oncol. 1999;17(2):658-67. 6 Von Pawel J, Jotte R, Spigel DR, et al. Randomized phase III trial of amrubicin versus topotecan as second-line treatment for patients with small-cell lung cancer. J Clin Oncol. 2014;32(35):4012-9. 7 Coutinho AD, Shah M, Lunacsek OE, et al. Real-world treatment patterns and outcomes of patients with small cell lung cancer progression after 2 lines of therapy. Lung Cancer. 2019;127:53-58. 8 Borghaei H, Pundole X, Anderson E, et al. Treatment patterns and outcomes in recent US clinical practice for SCLC patients after two prior lines of therapy. Presentation at World Conference on Lung Cancer 2023. September 9-12, 2023; Singapore, SGP. Poster #EP13.07-03. 9 Oronsky B, Abrouk N, Caroen S, et al. A 2022 Update on Extensive Stage Small-Cell Lung Cancer (SCLC). J Cancer. 2022;13:2945-2953. 10 World Health Organization. Lung. 2020. 11 Sabari JK, Lok BH, Laird JH, et al. Unravelling the biology of SCLC: implications for therapy. Nat Rev Clin Oncol. 2017;14:549-561.

Phase 1ImmunotherapyPhase 3Phase 2

18 Dec 2024

·www.investor.jnj.com

Johnson & Johnson submits application to the European Medicines Agency seeking approval of a new indication for IMBRUVICA® (ibrutinib) in adult patients with previously untreated mantle cell lymphoma (MCL) who are eligible for autologous stem cell tr

The European MCL Network Phase 3 TRIANGLE study, evaluated ibrutinib in combination with induction immunochemotherapy, both with and without an autologous stem cell transplant, followed by 24 months fixedduration ibrutinib therapy1 Both ibrutinib-based regimens, transplant-free and with transplant, delivered clinically meaningful improvement in efficacy compared to the current standard of care of induction immunochemotherapy followed by transplant2 BEERSE, BELGIUM (18 December 2024) – Janssen-Cilag International NV, a Johnson & Johnson company, today announced the submission of a Type II variation application to the European Medicines Agency (EMA). The submission seeks approval for an indication extension of IMBRUVICA® (ibrutinib) in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP) for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL), who are eligible for autologous stem cell transplant (transplant). This regulatory submission is supported by data from the TRIANGLE study, conducted by the European MCL Network. “Mantle cell lymphoma remains an incurable and challenging disease to treat, particularly in younger patients in need of durable frontline options,” said Edmond Chan, MBChB, M.D. (Res), EMEA Therapeutic Area Lead Haematology, Johnson & Johnson Innovative Medicine. “The TRIANGLE study demonstrates ibrutinib's potential to replace or compliment a transplantbased regimen, offering eligible patients a more effective path to long term remission and representing the first major step forward in frontline mantle cell lymphoma treatment in years.” The proposed indication is supported by results from the Phase 3 TRIANGLE study (NCT02858258) which investigated 870 patients across three treatment arms: standard induction immunochemotherapy followed by transplant, induction immunochemotherapy plus ibrutinib followed by transplant and 2-year fixed-duration ibrutinib therapy, and induction immunochemotherapy plus ibrutinib without transplant, followed by 2-year fixed-duration ibrutinib therapy.2,3 Prolonged efficacy and safety data from the TRIANGLE study were recently presented by the principal investigator Prof. Dr. Martin Dreyling, Ludwig Maximilian University of Munich, as an oral presentation at the 2024 American Society of Hematology (ASH) Annual Meeting.3 “At Johnson & Johnson, we are committed to investing in innovation that transforms clinical outcomes for those living with complex blood cancers, including mantle cell lymphoma,” said Jessica Vermeulen, Vice President, Oncology Late Development, Johnson & Johnson Innovative Medicine. “Today’s submission to the EMA could represent a pivotal step in moving beyond transplant as the frontline standard of care for younger patients with mantle cell lymphoma.” About Ibrutinib Ibrutinib is a once-daily oral medication that is jointly developed and commercialised by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.4 Ibrutinib blocks the BTK protein, which is needed by normal and abnormal B-cells, including specific cancer cells, to multiply and spread.5 By blocking BTK, ibrutinib may help move abnormal B-cells out of their nourishing environments and inhibits their proliferation. 6 Ibrutinib is approved in more than 100 countries and has been used to treat more than 300,000 patients worldwide.7 There are more than 50 companysponsored clinical trials, including 18 Phase 3 studies, over 11 years evaluating the efficacy and safety of ibrutinib.4,8 In October 2021, ibrutinib was added to the World Health Organization’s Model Lists of Essential Medicines (EML), which refers to medicines that address global health priorities and which should be available and affordable for all.9 Ibrutinib was first approved by the European Commission (EC) in 2014, and approved indications to date include:4 As a single agent or in combination with rituximab or obinutuzumab or venetoclax for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL) As a single agent or in combination with bendamustine and rituximab (BR) for the treatment of adult patients with CLL who have received at least one prior therapy As a single agent for the treatment of adult patients with relapsed or refractory MCL As a single agent for the treatment of adult patients with Waldenström’s macroglobulinaemia (WM) who have received at least one prior therapy, or in first line treatment for patients unsuitable for chemo-immunotherapy. In combination with rituximab for the treatment of adult patients with WM For a full list of adverse events and information on dosage and administration, contraindications and other precautions when using ibrutinib please refer to the Summary of Product Characteristics. About Mantle Cell Lymphoma (MCL) MCL is an aggressive type of blood cancer that originates from the B lymphocytes, a functional component of the human immune system.10 The overall incidence of MCL globally is approximately 1-2 cases per 100,000 persons per year and it has a higher prevalence in men than women.11 MCL typically affects individuals at 65-years of age at diagnosis.11 While patient outcomes have dramatically improved over the latest few decades, MCL remains a difficult disease to treat with many patients relapsing or becoming resistant to therapy.11 About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.innovativemedicine.jnj.com/emea. Follow us at www.linkedin.com/company/jnj-innovative-medicine-emea. Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., Janssen Biologics B.V. and Janssen Research & Development, LLC are Johnson & Johnson companies. Cautions Concerning Forward-Looking Statements  This press release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995 regarding product development and the potential benefits and treatment impact of ibrutinib. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialise, actual results could vary materially from the expectations and projections of Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., Janssen Research & Development, LLC, Janssen Biologics B.V. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; competition, including technological advances, new products and patents attained by competitors; challenges to patents; changes in behaviour and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in Johnson & Johnson’s subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at https://www.sec.gov/, http://www.jnj.com/ or on request from Johnson & Johnson. None of Janssen-Cilag International NV, Janssen Pharmaceutica NV, Janssen-Cilag Limited, Janssen Biotech, Inc., Janssen Research & Development, LLC, Janssen Biologics B.V. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 1 ClinicalTrials.gov. ASCT After a Rituximab/Ibrutinib/Ara-c Containing iNduction in Generalized Mantle Cell Lymphoma. NCT02858258. Available at: https://clinicaltrials.gov/study/NCT02858258. Last accessed: December 2024. 2Dreyling et al., Ibrutinib combined with immunochemotherapy with or without autologous stem-cell transplantation versus immunochemotherapy and autologous stem-cell transplantation in previously untreated patients with mantle cell lymphoma (TRIANGLE): a three-arm, randomised, open-label, phase 3 superiority trial of the European Mantle Cell Lymphoma Network. The Lancet, 2024; 403:10441:2293 - 2306 3Dreyling at al., Role of Autologous Stem Cell Transplantation in the Context of Ibrutinib-Containing First-Line Treatment in Younger Patients with Mantle Cell Lymphoma: Results from the Randomized Triangle Trial By the European MCL Network. Oral presentation. Abstract # 240. 2024 American Society of Hematology Annual Meeting. 4European Medicines Agency. IMBRUVICA Summary of Product Characteristics. September 2023. Available at: https://www.ema.europa.eu/en/documents/product-information/imbruvica-epar-product-information_en.pdf. Last accessed: December 2024. 5Turetsky A, et al. Single cell imaging of Bruton's tyrosine kinase using an irreversible inhibitor. Sci Rep. 2014;4:4782 6de Rooij MF, et al. The clinically active BTK inhibitor PCI-32765 targets B-cell receptor- and chemokine-controlled adhesion and migration in chronic lymphocytic leukemia. Blood. 2012. 119(11):2590-2594 7 J&J Data on File (RF-419273). Global number of cumulative patients treated with Ibrutinib since launch. June 2024. 8 Pollyea DA, et al. A Phase I Dose Escalation Study of the Btk Inhibitor PCI-32765 in Relapsed and Refractory B Cell Non-Hodgkin Lymphoma and Use of a Novel Fluorescent Probe Pharmacodynamic Assay. Blood. 2009. 114(22): 3713 9World Health Organization. WHO prioritizes access to diabetes and cancer treatments in new Essential Medicines Lists. Available at: https://www.who.int/news/item/01-10-2021-who-prioritizes-access-to-diabetes-and-cancer-treatments-in-new-essential-medicines-lists. Last accessed: December 2024. 10Jain P. and Wang M. L., Mantle cell lymphoma in 2022-A comprehensive update on molecular pathogenesis, risk stratification, clinical approach, and current and novel treatments, American Journal of Hematology. 2022; 97;5:638–56. 11Dreyling, M. et al. Newly diagnosed and relapsed mantle cell lymphoma: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Annals of Oncology, 2017; 28:62-71 Media contact: Jenni Mildon JMildon@its.jnj.com +44 7920 418 552 Investor contact: Lauren Johnson   investor-relations@its.jnj.com

ImmunotherapyPhase 3Drug ApprovalASHClinical Result

100 Deals associated with Vincristine Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D02197	Vincristine Sulfate	L01CA02	DB00541

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Pheochromocytoma	JP	Nippon Kayaku Co., Ltd.	26 Mar 2013
Astrocytoma	JP	Nippon Kayaku Co., Ltd.	14 Feb 2005
Glioma	JP	Nippon Kayaku Co., Ltd.	14 Feb 2005
Ewing Sarcoma	CN	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
Leukemia	CN	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
Leukemia	CN	Yangzhou Pharmaceutical Co., Ltd.	01 Jan 1982
Melanoma	CN	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
Neuroblastoma	CN	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
Neuroblastoma	CN	Yangzhou Pharmaceutical Co., Ltd.	01 Jan 1982
Small Cell Lung Cancer	CN	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
Wilms Tumor	CN	Jiangsu Qinfen Pharmaceutical Co., Ltd.	01 Jan 1982
acute leukemia	JP	Eli Lilly Japan KK	18 Apr 1968
Chronic leukemia	JP	Eli Lilly Japan KK	18 Apr 1968
Acute Lymphoblastic Leukemia	US	Eli Lilly & Co.	10 Jul 1963
Breast Cancer	US	Eli Lilly & Co.	10 Jul 1963
Bronchogenic Carcinoma	US	Eli Lilly & Co.	10 Jul 1963
Chronic Lymphocytic Leukemia	US	Eli Lilly & Co.	10 Jul 1963
Hodgkin's Lymphoma	US	Eli Lilly & Co.	10 Jul 1963
Lymphoma	US	Eli Lilly & Co.	10 Jul 1963
Multiple Myeloma	US	Eli Lilly & Co.	10 Jul 1963

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Adult Lymphoblastic Lymphoma	Phase 2	US	Amgen, Inc.	23 Jan 2025
Adult Lymphoblastic Lymphoma	Phase 2	US	Pfizer Inc.	23 Jan 2025
Pre B-cell acute lymphoblastic leukemia	Phase 2	US	Amgen, Inc.	23 Jan 2025
Pre B-cell acute lymphoblastic leukemia	Phase 2	US	Pfizer Inc.	23 Jan 2025
Classical Hodgkin's Lymphoma	Phase 2	US	Teva Pharmaceuticals USA, Inc.	12 Dec 2018
Classical Hodgkin's Lymphoma	Phase 2	US	Seagen Inc.	12 Dec 2018
Ph-Like Acute Lymphoblastic Leukemia	Phase 2	US	Spectrum Pharmaceuticals, Inc.	05 Mar 2013
ALK-positive anaplastic large cell lymphoma	Phase 2	US	Spectrum Pharmaceuticals, Inc.	06 Jul 2011
hepatosplenic T-cell lymphoma	Phase 2	US	Spectrum Pharmaceuticals, Inc.	06 Jul 2011
Immunoblastic Lymphadenopathy	Phase 2	US	Spectrum Pharmaceuticals, Inc.	06 Jul 2011

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03742258 (CTgov)	Phase 1	High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements \| T-cell/histiocyte rich large B-cell lymphoma	12	Spleen Tyrosine Kinase Inhibitor+Cyclophosphamide+Prednisone+doxorubicin hydrochloride+Rituximab+Vincristine Sulfate+TAK-659 (TAK-659 60mg + R-CHOP)	fffooqbfck(hexusbupco) = rgfjiwxlkf dfhjhquuls (jyruoqwgmg, xxhsmnrghy - ubjfwamzrn) View more	-	29 Jan 2025
				Doxorubicin Hydrochloride+Spleen Tyrosine Kinase Inhibitor+Cyclophosphamide+Prednisone+Rituximab+Vincristine Sulfate+TAK-659 (TAK-659 80mg + R-CHOP)	fffooqbfck(hexusbupco) = khrtmbdldt dfhjhquuls (jyruoqwgmg, pbjdbtealp - dcdzbbakbk) View more
ASH2024	Not Applicable	Acute Myeloid Leukemia	-	Cytarabine	mjwciskkuq(rbdprgcarr) = vguywpuftk vgxheggsvo (naywuchjav )	-	08 Dec 2024
				Vincristine	mjwciskkuq(rbdprgcarr) = ycyyehtmyi vgxheggsvo (naywuchjav )
ASH2024	Not Applicable	Non-Hodgkin Lymphoma	-	CMOP±R regimen	vmfzsktdbz(wuknxvsuaa) = ngitnecehq uzbvosoyxq (euqqhqdpah ) View more	-	08 Dec 2024
ASH2024	Not Applicable	Diffuse Large B-Cell Lymphoma	-	Zanubrutinib	gphobkkngj(bullewvecx) = Despite 44.9% of patients having high-risk CNS-IPI scores, no central nervous system relapses occurred during the follow-up period alcoexxaus (htgoqcluvf ) View more	-	07 Dec 2024
				Lenalidomide
ASH2024	Not Applicable	Non-Hodgkin Lymphoma	-	Levofloxacin 500 mg	vyzimrgvji(bxocxzrjxg) = shjgwutzhy xlqxxctjts (vrtphsjncn ) View more	-	07 Dec 2024
				Placebo	thiizysqxv(pqnetbwstt) = mxtbchsvaf lhcojylcpj (tyevothzih ) View more
ESMO2024 Manual	Not Applicable	Diffuse Large B-Cell Lymphoma G6PD deficiency	82	RituximabCyclophosphamideDoxorubicin HydrochlorideVincristine SulfatePrednisone	fscftvjycx(oxljadihjr) = dpwuhdtvbl ymyybgiufb (wvmyiayrfq ) View more	Negative	15 Sep 2024
				RituximabCyclophosphamideEtoposideVincristine SulfatePrednisone	fscftvjycx(oxljadihjr) = icoyiaedhx ymyybgiufb (wvmyiayrfq ) View more
NCT03792256 (CTgov)	Phase 1	Recurrent Adult Acute Lymphoblastic Leukemia \| T-Cell Lymphoma \| acute leukemia ... View more	12	ARAC (Stratum 1 With 50 mg/m^2)	yovocbntrm(keenzkiqpr) = gyyswhlwwv qfporoooxr (hnongxcomh, ucxwpzmekf - hupfcfhuew) View more	-	16 Aug 2024
				ARAC (Stratum PK With 50 mg/m^2)	yovocbntrm(keenzkiqpr) = gzjvpltwgc qfporoooxr (hnongxcomh, rzliesfpku - jprgzajcwn) View more
NCT00268853 (RAPID, CTgov)	Phase 2	Diffuse Large B-Cell Lymphoma	124	rituximab+Cyclophosphamide+Prednisone+pixantrone+CPOP-R+vincristine (CPOP-R)	nsthcxkuzw(lpfjbnuslt) = qfanojwqkr zwhivvzvnc (oflpbtzgju, ginbjwxmur - yykcxpimim) View more	-	30 May 2024
				rituximab+Cyclophosphamide+Prednisone+doxorubicin+vincristine+CHOP-R (CHOP-R)	nsthcxkuzw(lpfjbnuslt) = syunhbrnep zwhivvzvnc (oflpbtzgju, hfheysmiyg - sqcvizrwug) View more
NCT02073097 (CTgov)	Phase 1/2	Diffuse Large B-Cell Lymphoma	48	Pegfilgrastim+Acyclovir+Carfilzomib+cyclophosphamide+Prednisone+doxorubicin hydrochloride+Rituximab+Vincristine sulfate	ovrsnhgfwg(xsxccrjupz) = yctnkxugzz gnquhwjenh (rvrnsajyda, whximklngv - heyiyhineo) View more	-	29 May 2024
NCT04947501 (N9, ASCO2024) Manual	Early Phase 1	High Risk Neuroblastoma	15	cyclophosphamidehostopotecanopovincristineistifosfamidecarboplatinetoposide	rourtvkkbx(hvezxumfve) = czcqiclidw ypsiktmpbz (ngnzgpvlir ) View more	Positive	24 May 2024
				cyclophosphamideplatopotecansidvincristineifosfamidecarboplatinetoposide	yvyiuzvbsu(kfyxqgaoyh) = yainanafzl bmybpubuzr (layxtxebnn ) View more

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

Chat with Hiro

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis