^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Folotyn (pralatrexate)

    i
    Other names: PDX, 10-propargyl-10-deazaaminopterin
    Company:
    Assertio, Aurobindo, CASI, Mundipharma
    Drug class:
    THF dehydrogenase inhibitor
    Related drugs:
    12d
    Fusion-positive rhabdomyosarcoma oncofusions share a common interactome. (PubMed, Nat Commun)
    Accordingly, the antifolate pralatrexate suppressed growth across all seven oncofusions, in multiple human FP-RMS cell lines, and a patient-derived xenograft. These findings demonstrate that divergent FP-RMS oncofusions are functionally fungible through a shared interactome that defines common vulnerabilities.
    Journal
    |
    TYMS (Thymidylate Synthetase) • PAX3 (Paired Box 3)
    |
    Folotyn (pralatrexate)
    15d
    Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas (clinicaltrials.gov)
    P1/2, N=13, Active, not recruiting, City of Hope Medical Center | Trial completion date: Feb 2026 --> Feb 2027
    Trial completion date
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK negative
    |
    Keytruda (pembrolizumab) • Folotyn (pralatrexate)
    2ms
    Pralatrexate With Bendamustine and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=50, Recruiting, Fred Hutchinson Cancer Center | Not yet recruiting --> Recruiting
    Enrollment open
    |
    CD33 (CD33 Molecule) • HLA-DRB1 (Major Histocompatibility Complex, Class II, DR Beta 1) • HLA-DQB1 (Major Histocompatibility Complex, Class II, DQ Beta 1) • HLA-B (Major Histocompatibility Complex, Class I, B) • HLA-C (Major Histocompatibility Complex, Class I, C)
    |
    bendamustine • Folotyn (pralatrexate)
    2ms
    Soquelitinib vs Standard of Care in Participants With Relapsed/Refractory Peripheral T-cell Lymphoma Not Otherwise Specified, Follicular Helper T-cell Lymphomas, or Systemic Anaplastic Large-cell Lymphoma (clinicaltrials.gov)
    P3, N=150, Recruiting, Corvus Pharmaceuticals, Inc. | Trial completion date: Jul 2028 --> Dec 2028 | Trial primary completion date: Nov 2026 --> Nov 2027
    Trial completion date • Trial primary completion date
    |
    Beleodaq (belinostat) • Folotyn (pralatrexate) • soquelitinib (CPI-818)
    7ms
    A Phase 3 Multinational Study of Golidocitinib Versus Investigator's Choice in r/r PTCL (JACKPOT19) (clinicaltrials.gov)
    P3, N=218, Recruiting, Dizal Pharmaceuticals
    New P3 trial
    |
    gemcitabine • Epidaza (chidamide) • Beleodaq (belinostat) • Folotyn (pralatrexate) • golidocitinib (DZD4205)
    7ms
    Pralatrexate With Bendamustine and Total-Body Irradiation Followed by Donor Stem Cell Transplant for the Treatment of Relapsed or Refractory T-Cell Non-Hodgkin Lymphoma (clinicaltrials.gov)
    P1/2, N=50, Not yet recruiting, Fred Hutchinson Cancer Center
    New P1/2 trial
    |
    CD33 (CD33 Molecule)
    |
    bendamustine • Folotyn (pralatrexate)
    7ms
    A prospective, single-center, single-arm clinical study evaluating the efficacy and safety of pralatrexate combined with chidamide and azacitidine in adult patients with newly diagnosed peripheral T-cell lymphoma (ChiCTR2500109351)
    P2, N=20, Not yet recruiting, The FIrst Affiliated Hospital, College of Medicine, Zhejiang University; The FIrst Affiliated Hospital, College of Medicine, Zhejiang University
    New P2 trial
    |
    ALK negative
    |
    azacitidine • Epidaza (chidamide) • Folotyn (pralatrexate)
    10ms
    Study of Pembrolizumab Combined With Decitabine and Pralatrexate in PTCL and CTCL (clinicaltrials.gov)
    P1, N=37, Active, not recruiting, University of Virginia | Recruiting --> Active, not recruiting | Trial completion date: Dec 2025 --> May 2026
    Enrollment closed • Trial completion date
    |
    Keytruda (pembrolizumab) • decitabine • Folotyn (pralatrexate)
    11ms
    One-Carbon Metabolism Inhibition Depletes Purines and Results in Profound and Prolonged Ewing Sarcoma Growth Suppression. (PubMed, Cancer Res Commun)
    Inhibition of one-carbon metabolism at a different node, using the clinically relevant dihydrofolate reductase inhibitor Pralatrexate, similarly yields a profound growth inhibition, with depletion of thymidylate and purine nucleotides. Genetic depletion of SHMT2 dramatically impairs tumor growth in a xenograft model of EWS. Together, these data establish dependence on one-carbon metabolism as a novel and targetable vulnerability of EWS cells, which can be exploited for therapy.
    Journal
    |
    SHMT2 (Serine Hydroxymethyltransferase 2)
    |
    Folotyn (pralatrexate)
    11ms
    Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL (clinicaltrials.gov)
    P2, N=50, Recruiting, University of Virginia | Trial completion date: Jun 2028 --> Jun 2030 | Trial primary completion date: Jun 2026 --> Jun 2028
    Trial completion date • Trial primary completion date
    |
    gemcitabine • azacitidine • romidepsin • Beleodaq (belinostat) • Folotyn (pralatrexate)
    11ms
    Case series of long-term responders to pralatrexate in peripheral T-cell lymphoma. (PubMed, J Clin Exp Hematop)
    There were no pathological or immunohistochemical findings common to cases that responded to pralatrexate, however, of the four PTCL-NOS patients, two were GATA3 positive. Although there are limitations due to the number of cases, considering that the response rate of pralatrexate for PTCL-NOS in existing studies was 32%, these results may lead to future advances in PTCL treatment.
    Journal
    |
    GATA3 (GATA binding protein 3)
    |
    Folotyn (pralatrexate)
    12ms
    Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T-Cell Lymphomas (clinicaltrials.gov)
    P1/2, N=13, Active, not recruiting, City of Hope Medical Center | Trial completion date: Jun 2025 --> Feb 2026
    Trial completion date
    |
    ALK (Anaplastic lymphoma kinase)
    |
    ALK positive • ALK negative
    |
    Keytruda (pembrolizumab) • Folotyn (pralatrexate)